Contract Service Directory
PSC Software
Company Headquarters
700
Corporate Center Drive
Pomona, CA 91768
United States
Other Locations
700 Corporate Center Drive
Pomona, CA 91768
United States
Contract Service Directory
- Auditing
- Cold Chain Management
- Consulting, Audits & Inspections
- Consulting, Quality Management Systems
- Consulting, Records Management
- Custom Protocols
- Data Management
- Database Systems
- Electronic Data Capture
- Electronic Data Management
- QA/QC
- Regulatory Affairs Consultants
- Software
- Supply Chain Auditing
- Supply Chain Management
- System Integration
- Training
- Training: cGMP/HPB/FDA Compliance
- Training: Process Validation
- Training: Safety
Contract Services Directory
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APIs | Drug Development
API Development Trends
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APIs | Solid Dosage/Creams/Ointments
Spray Drying: A Proven Approach to Enhance the Solubility of APIs
Spray drying is an established particle engineering technology that offers several advantages over other methods used for improving API bioavailability.Benzion Dolitzky, PhD, VP R&D, Wavelength Pharmaceuticals 09.09.21
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APIs | Clinical Trial Materials
Outsourcing the Manufacture of Clinical Trial APIs
What to consider when deciding to partner with a CDMO for manufacturing.Josh Hoerner, General Manager, Purisys 09.09.21
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Drug Delivery
Inhaled Drug Delivery Trends
Designing dry powder devices for inhaled drugs.Andreas M. Meliniotis, Director of Device Development, Vectura 09.09.21
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A Strong Partnership in Drug Development
How CDMOs and consultants mutually benefit their clients.09.09.21
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Clinical Trial Materials | Clinical Trials | Supply Chain
Clinical Trial Kitting
Overcome the challenges to make every sample count.Claudia Berrón and Arbi Harootoonian, Avantor 09.09.21
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Drug Development
Partnering with a CDMO for Orphan Drug Development
Challenges and considerations for advancing rare disease drugs to market.Susan Billings, Vice President & Global Head of Business Development, Curia (formerly known as AMRI) 09.09.21
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Analytical Services | Bioanalytical Services
Putting Laboratory Suppliers to the Test in the COVID Era – and Beyond
Build resiliency into analytical methods through careful consideration of chromatography partners.Hazel Dickson, PhD, Marketing Manager, Chemistry Group, Waters Corporation 09.09.21
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Choosing and Managing a CDMO
Speed up your time-to-market, keep development costs under control and smooth the FDA approval and commercial launch process.Dana Toops, President, Avema Pharma Solutions 09.09.21
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Global Outsourcing Trends
Lonza’s Jan Vertommen talks about building global manufacturing and development networks to advance innovative, life-saving therapies.Tim Wright, Editor, Contract Pharma 09.09.21
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cGMP Manufacture | Drug Development | QA/QC
Three Tips for Navigating Post-Approval Pharmacovigilance
Seamlessly transition from regulatory reporting to post-approval safety surveillance in today’s market.Emmanuel Belabe, Associate Vice President, Safety Product Management, ArisGlobal, Nina Patel Lahanis, Associate Vice President, Safety Science, EVERSANA 09.08.21
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
CEVEC, UCB Ink AAV Mfg. Technology Agreement
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Breaking News | Collaborations & Alliances | Drug Development | Drug Discovery
Adaptimmune, Genentech Enter Strategic R&D Collaboration
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Clinical Trials | Information Technology
Clinical Trials are Transforming Right Before Our Eyes
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Breaking News | Industry News | Packaging & Tracking
High Purity New England Expands Single-Use Portfolio
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Aseptic Processing | Breaking News | Industry News | Promotions & Moves
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Breaking News | Facilities | Industry News
Formulated Solutions Completes Expansion
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Biologics, Proteins, Vaccines | Breaking News
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Aseptic Processing | Breaking News | cGMP Manufacture | Promotions & Moves
Pii Names Head of Aseptic Operations
Roberto Almodóvar Febles will oversee and manage day-to-day aseptic manufacturing.08.31.21
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Breaking News | Industry News | Promotions & Moves
Forge Biologics Expands Leadership Team
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Bio News | Breaking News | Collaborations & Alliances | Industry News
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Breaking News | Collaborations & Alliances | R&D
Roche, Shape Therapeutics Enter Strategic Gene Therapy Collaboration
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APIs
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Bio News | Breaking News | Industry News
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cGMP Manufacture | Fill/Finish | Parenterals
Modularity in Injectables Manufacturing
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Breaking News | Facilities | Industry News
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Clinical Trials | Information Technology
Enabling Decentralized Clinical Trials through Digital Transformation
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Breaking News | Facilities | Industry News | Packaging & Tracking
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Bachem Capabilities to Address the New FDA Guideline for Synthetic Peptides
Scientific and regulatory challenges remain a big hurdle on the way to successful approval of generic drugs falling under this guideline.
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Analytical Services | Biologics, Proteins, Vaccines | Cold Chain Management | GMPs/GCPs | Scale-up/Technology Transfer | Serialization | Solid Dosage/Semi-solids | Vials
CMO Becoming a Powerhouse With Expansions and New Facilities, Looking to Add Strategic Customers
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APIs
Generic APIs Portfolio
With almost 50 years of expertise in peptide and small molecule synthesis, Bachem has an outstanding track record in large-scale manufacturing.
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Breaking News | Industry News
Catalent, Edenbridge Pharma Enter Zydis Formulation Supply Agreement
Novel formulation of glycopyrrolate will use Catalent’s Zydis ODT delivery technology for adjunctive therapy for the treatment of peptic ulcer.08.10.21
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Breaking News | cGMP Manufacture | Drug Development | Promotions & Moves
Metrics Appoints Senior Director, Scientific and Technical Affairs
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Breaking News | Industry News
KYOWA, Bora Pharmaceuticals Enter Mfg. Pact
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Breaking News | Financial Reports
BioNTech’s 2Q Revenue Soars
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Biologics, Proteins, Vaccines | cGMP Manufacture
A Look Into COVID Vaccines, Development and Outsourcing
Fiona Barry of PharmSource discusses COVID vaccines in development and CMO outsourcing trends.08.09.21
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Breaking News | Collaborations & Alliances | Industry News
Purdue University & US Pharmacopeia Launch Pharmaceutical Industry Technology Forum
The webinar series will focus on the benefits of 3D-Printing pharmaceutical medications.08.05.21
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The Real Cost of Bringing Manufacturing Home
Bikash Chatterjee of Pharmatech Associates discusses the reshoring trend, technologies and advances that could help deliver more manufacturing back to the U.S.08.04.21
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
Global Cell & Gene Therapy Mfg. Market Could Reach $57.4B by 2028
Market estimated to grow at CAGR of 20% from 2021 to 2028 due to an exponential rise in clinical pipeline along with rising number of regulatory approvals.07.30.21
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Breaking News | Drug Development | Industry News
Lantern Pharma Reacquires Irofulven from Allarity Therapeutics
Based on early Phase II results, Lantern to advance development in bladder and prostate cancer with a key mutation in the ERCC2/3 genes.07.28.21
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Breaking News | Facilities | Industry News
Archimica Completes Expansion of Its Multi-Purpose Manufacturing Capacity
Recent investment adds significantly to the company's capabilities.07.27.21
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Breaking News | Collaborations & Alliances | Industry News
CatSci and Argonaute RNA Enter CMC Development Collaboration
Aim to expedite oligonucleotide manufacturing for gene-silencing therapeutics.07.27.21
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Bio News | Breaking News | Collaborations & Alliances | Industry News
AavantiBio, Aldevron Form Gene Therapy Partnership
Aldevron will supply plasmids to AavantiBio’s planned vector core and CDMO partners.07.27.21
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Breaking News | cGMP Manufacture | Industry News
WuXi Biologics Receives Manufacturing License from German Health Authorities
The inspections comprised areas of cGMP manufacturing required for receiving the permit, as well as commercial production approval.07.26.21
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Breaking News | Clinical Trials | Industry News | Information Technology
WCG Acquires eClinical Provider VeraSci
Aims to address growing demand for scientific and technology solutions for remote data capture, hybrid virtual studies and decentralized clinical trials.07.26.21
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Breaking News | Facilities
Capsida Biotherapeutics Opens Facility in Thousand Oaks
New 15,000 square-foot facility will enable industry leading end-to-end gene therapy manufacturing capability.07.23.21
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Bio News | Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News
Marvel Biotechnology Begins cGMP Manufacturing of Lead Candidate
Enters manufacturing agreement with Ausun Pharma for lead asset MB-204.07.22.21
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Breaking News | CRO News | Industry News
Calyx Expands US Presence in Response to Growing Demand
RTP-based US headquarters established to meet pharmaceutical companies’ and CROs’ increasing needs for e-clinical and regulatory solutions.07.22.21
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Breaking News | Promotions & Moves
TCR2 Therapeutics Appoints Chief Technical Officer
Peter Olagunju to oversee process development, manufacturing, quality control and technical operations for the company’s TRuC-T cell programs.07.21.21
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Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
Intravacc's Inactivated Polio Vaccine Out-licensed to Sinovac
Sinovac's Eupolio vaccine (sIPV) receives market authorization from the NMPA in China.07.20.21
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Clinical Trials | CRO News | Information Technology | Reader Showcase
Quanticate Launches Updated Remote Source Data Verification Platform
Cloud-based application allows verification of multiple clinical research sites’ source data to be completed remotely by specialist team at centralized location07.19.21
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Breaking News | Clinical Trials | Industry News | Information Technology
Calyx Opens U.S. HQ Near Research Triangle Park
RTP-based headquarters established to meet growing needs for eClinical and regulatory services.07.19.21
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Drug Development | Industry News
BioNTech to Acquire Kite’s TCR Cell Therapy Platform and Mfg. Facility
Strengthens cell therapy pipeline with individualized solid tumor Neoantigen TCR cell therapy R&D program and adds manufacturing footprint in North America.07.19.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Clinical Trial Materials | Industry News
GentiBio, Forge Biologics Ink Development and Manufacturing Agreement
Partnership to support GentiBio’s cell therapy pipeline with AAV process development, scale up and GMP manufacturing services.07.16.21
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APIs | Breaking News | cGMP Manufacture | Industry News
MediPharm Labs Receives Canadian GMP Pharmaceutical DEL
License can be used for manufacturing, testing and sale of APIs and pharmaceutical drug products containing cannabis.07.15.21
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Analytical Services | Breaking News | Industry News | Information Technology
LabVantage Introduces Version 8.7 of its LIMS Platform
Provides external customer self-service access to LIMS while maintaining the laboratory’s data security.07.14.21
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Breaking News | Collaborations & Alliances
Bicycle Therapeutics, Ionic Pharma Enter License & Collaboration Agreement
Will work together to develop targeted oligonucleotide therapeutics leveraging tissue-targeting TfR1 Bicycle technology.07.13.21
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Breaking News | Industry News
AMRI Becomes Curia
New brand reinforces ongoing expansion of expertise, capabilities and contributions to health care.07.12.21
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Laboratory Testing
Overcoming the Customization Conundrum
A case study on automating diagnostic reagent filling.Deborah Smook, VP of Marketing & Business Development, TurboFil Packaging Machines LLC 07.12.21
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Breaking News | Industry News | QA/QC | Regulatory Affairs | Supply Chain
United States Pharmacopeia Acquires Pharmatech Associates
Expanded offerings will help regulated life science companies strengthen the supply chain for safe, quality medicines.07.09.21
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Analytical Services | Breaking News | Industry News | Laboratory Testing
LGM Pharma Launches Analytical Services for Drug Developers and Manufacturers
Analytical testing and stability services covers both drug substance and drug product.07.08.21
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Breaking News | cGMP Manufacture
Thermo Fisher Scientific Expands Gene Therapy Portfolio
Adds new set of solutions to support more efficient adeno-associated viral manufacturing.07.07.21
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VectorBuilder, Univercells Form Viral Vector Production Pact
Aims to develop a portfolio of optimized viral vector manufacturing protocols.07.06.21
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Facilities | Laboratory Testing | Logistics
A Guide to Outsourced Stability Storage
Watch the on-demand webinar presented by Maureen Gilbert, Site General Manager at Source BioScience.
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Breaking News | cGMP Manufacture | Drug Development | Industry News
Hermes Pharma Announces Spin-out from Hermes Arzneimittel
CDMO specializes in the development and manufacture of user-friendly oral dosage forms for healthcare companies around the world.07.02.21
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Breaking News | Promotions & Moves
Avid Bioservices Appoints Esther M. Alegria to Board
Former SVP of global manufacturing at Biogen bring nearly 30 years of biopharmaceutical industry experience.07.02.21
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Breaking News | Collaborations & Alliances | Facilities | Industry News
WuXi STA Chooses Middletown Delaware for New Pharma Manufacturing Campus
The CDMO is bringing about 500 jobs to Middletown, with site expected to open in 2024.06.29.21
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APIs | Breaking News | cGMP Manufacture | Cytotoxics and High Potency Manufacturing | Industry News
Lonza Expands API Development, Mfg. Facility in China
20M CHF investment will include three 1,000L GMP trains and new development and GMP labs with HPAPI capabilities.06.28.21
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Analytical Services | Bioassay Development | Biologics, Proteins, Vaccines | Drug Development
Host Cell Impurities, Bioassays, Micro-Flow Imaging
WHO, FDA and the European Pharmacopoeia have established strict regulatory guidelines to guarantee product quality in biologics.
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Formulation Development
Tryp Therapeutics Partners with Alcami for Proprietary Formulations
The agreement represents another step toward the proprietary manufacturing, formulation, and delivery of products for Tryp’s PFNTM program.
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Clinical Trials | Information Technology
The Power and Promise of Decentralized Trials
Clinical researchers turned to a range of digital solutions to address the effects of the COVID-19 pandemic on trials.Derk Arts, CEO, Castor 06.25.21
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APIs | Breaking News | Facilities | Industry News
Novasep Upgrades API Manufacturing Facility
A $7.3 million investment will be made over 3 years to modernize the Mourenx site.06.25.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News | Process Development
Catalent to Acquire RheinCell Therapeutics
Strengthens path towards industrialization of induced pluripotent stem cell-based therapies.06.25.21
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Breaking News | Collaborations & Alliances
CellPoint and Lonza Enter CAR-T Cell Collaboration
Will work together to deliver CAR-T Cell therapies to patients at point-of-care.06.24.21
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Breaking News | Collaborations & Alliances
Cellenkos Chooses Cryoport to Support Covid-19 Therapy Shipments to Patients
Cryoport will provide tracking and proactive management for the therapies.06.22.21
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Breaking News | Clinical Trials | CRO News
Syneos Expands Decentralized Trial Capabilities
Aims to accelerate decentralized clinical trial delivery through collaboration with site sponsors.06.22.21
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APIs | Supply Chain
Maintaining Critical Drug Supply During the Pandemic
Vin Colicchio from Dr. Reddy’s talks about the challenges and solutions of maintaining supply during the pandemic.Tim Wright, Editor, Contract Pharma 06.17.21
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Breaking News | Collaborations & Alliances | Industry News
KBI Biopharma, AM-Pharma Enter Manufacturing Agreement
Partnership supports future commercial manufacturing for AM-Pharma’s potential kidney disease treatment.06.17.21
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Breaking News | Facilities | Industry News | Lyophilization
Horizon Therapeutics Buys EirGen Manufacturing Facility
The 44,000 square foot facility in Ireland includes fill-finish and analytical laboratory capabilities with potential for site expansion.06.17.21
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Clinical Trial Materials | Cold Chain Management | Logistics | Supply Chain
Mitigating the Logistical Challenges Associated with Clinical Studies of Investigational Drugs
How Sentry BioPharma Services supports clinical studies with just-in-time custom labeling/kitting/packaging and more.Contract Pharma Staff
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Tablet Development Process Training - July 20-21
This course provides comprehensive insight into the tablet development process to provide powerful tools that you can put to work immediately.
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News | Parenterals
Ocugen, Jubilant Enter COVID-19 Vaccine Partnership
Jubilant HollisterStier to manufacture COVAXIN for the U.S. and Canadian markets.06.15.21
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Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Drug Development | Trials & Filings
Novavax COVID-19 Vax is 90% Effective in Phase 3 Trial
NVX-CoV2373 demonstrates 100% protection against moderate and severe disease, 90% efficacy overall, and met the primary endpoint.06.14.21
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Bio News | Breaking News | Clinical Trial Materials | Clinical Trials | Collaborations & Alliances | Drug Delivery | Industry News | Solid Dosage/Creams/Ointments
Enteris BioPharma Receives $10M Milestone from Cara Therapeutics
Third milestone payment related to the development of Oral KORSUVA.06.11.21
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Bio News | Breaking News | cGMP Manufacture | Clinical Trial Materials | Collaborations & Alliances | Industry News
Revolo and Northway Biotech Enter Manufacturing Partnership
To manufacture novel binding immunoglobulin protein, ‘1805, to support phase 2 trials in rheumatoid arthritis and uveitis.06.11.21
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Analytical Services | Bioanalytical Services | Breaking News | Facilities | Industry News | Laboratory Testing
CatSci Opens New Dagenham Laboratory
New facility is equipped with state-of-the-art analytical equipment through a collaboration with Shimadzu Corporation.06.09.21
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Clinical Trials | CRO News | Industry News | Information Technology
Bioclinica Adds eConsent to EDC Platform
New electronic module is built to support the entire consent process from document approval by IRBs to in-person or remote interactions.Kristin Brooks 06.08.21
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Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Industry News
INOVIO, Advaccine Expand COVID Vax Alliance
To jointly conduct a global Phase 3 segment of the ongoing Phase 2/3 INNOVATE trial evaluating INO-4800 in a two-dose regimen.Kristin Brooks 06.08.21
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Breaking News | Facilities | Industry News | Inspections
CPL Completes Successful Virtual Health Canada Audit
The CDMO created a virtual tour of its facilities in response to the pandemic.Tim Wright, Editor, Contract Pharma 06.03.21
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Clinical Trials | CRO News | Drug Development | Information Technology
Driving Efficiencies in Today’s Complex Trials
Murray Aitken of IQVIA discusses CRO market trends, post-pandemic opportunities, and leveraging tech-enabled services and capabilities.Kristin Brooks, Managing Editor, Contract Pharma 06.03.21
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Breaking News | Collaborations & Alliances | Industry News
PharmaBlock Sciences Partners with Shouyao Holdings
Will support CMC development and manufacturing of Shouyao’s second-generation ALK inhibitor for non-small cell lung cancer.Charles Sternberg, Assistant Editor 06.03.21
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APIs | Breaking News | cGMP Manufacture | Industry News
Onyx Scientific Receives Commercial API License for UK Facility
Allows Onyx to support API projects from pre-clinical studies to low volume commercial manufacture.Charles Sternberg, Assistant Editor 06.03.21
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Clinical Trials | Drug Development
The Future is Decentralized: What This Means for Clinical Trial Sites
Benefits for research sites and how to prepare for decentralized trials.Marc Leighton, Vice President of Product at Florence Healthcare 06.02.21
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Bioanalytical Services | Bioassay Development | Biologics, Proteins, Vaccines
The Future of Continuous Bioprocessing
The modernization of advanced therapy manufacturing.Dr. Karoline Hahn, Senior Consultant for Advanced Therapies, KCR 06.02.21
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Bioanalytical Services | Biologics, Proteins, Vaccines
The Future of Continuous Bioprocessing
The Modernization of Advanced Therapy ManufacturingDr. Karoline Hahn, Senior Consultant for Advanced Therapies, KCR 05.27.21
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Breaking News | Collaborations & Alliances | Industry News
Hovione and iBET Form Strategic Collaboration
Will combine knowledge from both partners to create innovation in new therapeutic fields.Tim Wright, Editor, Contract Pharma 05.27.21
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Biologics, Proteins, Vaccines | Clinical Trials | Drug Development
Gene Therapy Trials
Critical regulatory and study start-up questions for gene therapy trials in the U.S., UK, and Europe.April Marquick, Cell and Gene Therapy Expert, Premier Research 05.26.21
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Breaking News | cGMP Manufacture | Industry News | Information Technology
Novatek Requalified as Supplier for Boehringer Aseptic Mfg. Facilities
Novatek's regulatory compliant quality solutions used at Boehringer for human pharma, animal health and biopharmaceutical sterile manufacturing sites.Kristin Brooks 05.26.21
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Biologics, Proteins, Vaccines | Breaking News | Industry News
MilliporeSigma Accelerates Scale Up of Lipids to Meet Covid Demand
One of a few companies that produces lipids in quantities needed to meet demand for mRNA therapeutics, including Pfizer-BioNTech Covid-19 vaccine.Kristin Brooks 05.26.21
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Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News
Cambrex Adds Kilogram-Scale Mfg. Capabilities at Estonia
Building work and installation of the new reactor and supporting equipment is now complete, and preparation for GMP qualification is underway.Kristin Brooks 05.26.21
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Analytical Services | Breaking News | Facilities | Industry News | Laboratory Testing
Almac Sciences Invests in Continuous Flow Chemistry Equipment
Furthers its most recent laboratory expansion.Charles Sternberg, Assistant Editor 05.25.21
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Breaking News | CRO News | Industry News
Premier Research Acquires Camargo Pharmaceutical Services
Expands product planning, development and differentiation services offered.Tim Wright, Editor, Contract Pharma 05.21.21
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Breaking News | Drug Development | Formulation Development | Industry News | Solid Dosage/Creams/Ointments
Recro, Astex Enter Drug Development Alliance
Expands partnership for oral solid dose drug product services.Kristin Brooks 05.18.21
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Bio News | Breaking News | Collaborations & Alliances | Drug Development | Industry News | R&D
BioMedX Extends Collaboration with Merck
Merck will support up to six more research groups at the BioMed X Institute in Heidelberg within the next six years.Charles Sternberg, Assistant Editor 05.17.21
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Bio News | Bioanalytical Services | Biologics, Proteins, Vaccines | Breaking News | Industry News
PerkinElmer Acquires Nexcelom Bioscience
Bolsters preclinical portfolio and enhances QA/QC capabilities in cell and gene therapy and biologics manufacturing.Tim Wright, Editor, Contract Pharma 05.17.21
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Breaking News | Collaborations & Alliances | Industry News
Zynrelef Anesthetic Receives FDA Approval
Lifecore will manufacture the new innovative drug for treatment of postoperative pain.Charles Sternberg, Assistant Editor 05.17.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News | Parenterals
Humanigen Selects Chime Biologics as Manufacturing Partner
Ink manufacturing deal for COVID-19 therapeutic candidate lenzilumab.Tim Wright, Editor, Contract Pharma 05.17.21
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Breaking News | Cytotoxics and High Potency Manufacturing | Facilities | Industry News
Novasep Expands HPAPI Manufacturing Capacity
Responds to increasing customer demand for manufacturing services for antibody drug conjugates.Tim Wright, Editor, Contract Pharma 05.13.21
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Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News
Northwest Bio Seeks GMP Certification of Sawston Mfg. Facility
Upon initial license, production of GMP DCVax-L products in the Sawston facility may begin by the end of Q3.Kristin Brooks 05.12.21
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Bio News | Breaking News | Facilities
NJ Bio Moves Headquarters to Princeton, New Jersey
The 35,000-square-foot site was formerly occupied by Bristol Myers Squibb.Tim Wright, Editor, Contract Pharma 05.11.21
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Bio News | Breaking News | cGMP Manufacture | Cytotoxics and High Potency Manufacturing | Facilities | Industry News | Solid Dosage/Creams/Ointments
Enteris BioPharma Completes Expansion of Manufacturing Facility
Also launches CDMO business for the development and manufacture of difficult to formulate drugs and highly potent compounds.Tim Wright, Editor, Contract Pharma 05.11.21
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Biologics, Proteins, Vaccines | Breaking News | Industry News
Novavax, Gavi Execute APA for COVID-19 Vax
Novavax to deliver 350 million doses beginning 3Q21.Kristin Brooks, Contract Pharma 05.06.21
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The Word ‘Innovation’ Probably Doesn’t Mean What You Think It Does
Innovation in manufacturing can come in many forms.Ben Locwin, Contributing Editor, International COVID-19 Advisor, Healthcare Futurist 05.05.21
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The Changing Nature of Communications
Is Zoom burnout leading to a resurgence of the “good-ol” phone call?David G. Jensen, Contributing Editor 05.05.21
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Ensuring Pharma Manufacturing Quality
How today’s life sciences manufacturers can effectively monitor processes, integrate with sub-contractors and align with regulatory reporting requirements.Shahid Manzur, Principal, EY Consulting 05.05.21
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CDMO Market Trends & Opportunities
CDMOs have been some of the biggest winners from COVID contracts and will see benefits for several more years to come. A Q&A with GlobalData’s Peter Shapiro.Tim Wright, Editor, Contract Pharma 05.05.21
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Fast Track Automation in Pharmaceutical Manufacturing
Drug manufacturers turn to advanced automation technologies and project execution methodologies to reduce time, cost and risk.Steve Zarichniak, Technical Solutions Consultant, Honeywell Process Solutions 05.05.21
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Are Your Suppliers Supporting Your Growth?
The role of strategic sourcing and procurement for emerging biopharmaceutical companies.Dave Stowe and Jonathan Horn, Tunnell Consulting 05.05.21
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Bio News | Breaking News | Collaborations & Alliances | Industry News
BioVaxys Inks Deal with CDMO BioElpida
Includes clinical-grade bioproduction and aseptic packaging for ovarian cancer vaccine candidate BXV-0918A.Tim Wright, Editor, Contract Pharma 05.05.21
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Breaking News | Clinical Trials | CRO News | Information Technology
Syneos, Komodo Health Expand Data App Alliance
Leveraging Komodo’s Healthcare Map, Syneos aims to better analyze clinical, real-world, and commercial data.Kristin Brooks 05.04.21
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Clinical Trials | Information Technology | Promotions & Moves
Clinical Ink Adds Executives
CCO Chris Crucitti, COO Brian Donahue, and VP Project Operations Bill Barrasso to manage eSource platforms.Kristin Brooks 05.04.21
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Bio News | Breaking News | Drug Development | Drug Discovery | Facilities | Industry News | Information Technology
AbCellera Breaks Ground on Global HQ in Vancouver
380,000 square feet of facilities envisioned as creative tech hub expected to be completed in 2023 and 2024.Tim Wright, Editor, Contract Pharma 05.03.21
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Bio News | Breaking News | Facilities | Industry News
NuvOx Completes Construction of Expanded Manufacturing Facility
Will manufacture its lead product, NanO2, for clinical trials and commercial supply after FDA approval.Tim Wright, Editor, Contract Pharma 05.03.21
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Analytical Services | Bioanalytical Services | Breaking News | cGMP Manufacture | Drug Development | Industry News | R&D
AMRI Adds R&D and Mfg. Solutions for Orphan Products
Targeted investments globally expand scale and compound handling capabilities at facilities in Albany, Grafton, and Glasgow.Kristin Brooks 04.30.21
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Breaking News | Facilities | Fill/Finish | Industry News
Grand River Aseptic Manufacturing Earns Facility of the Year Award
Receives special recognition for operational agility during the pandemic.Charles Sternberg, Assistant Editor 04.29.21
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Analytical Services | Bioanalytical Services | Breaking News | CRO News | Facilities | Industry News
PPD to Expand GMP Lab in Ireland
Adding cell and gene therapy capabilities to support growing customer need.Tim Wright, Editor, Contract Pharma 04.29.21
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Breaking News | Collaborations & Alliances | Industry News
Elektrofi, Argenx Enter Collaboration and License Agreement
Will explore new subcutaneous formulations for therapeutic products directed at the human neonatal Fc receptor.Charles Sternberg, Assistant Editor 04.27.21
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Breaking News | Industry News
Aceto Acquires A&C
Increases its GMP manufacturing, packaging, and ingredients offerings for the cell culture, vaccine, and biopharmaceutical industries.Charles Sternberg, Assistant Editor 04.27.21
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Breaking News | Facilities | Industry News | Inspections
Bora Pharmaceuticals Completes Health Canada Inspection
Mississauga site is the company’s first manufacturing facility in North America and is its HQ in the region.Tim Wright, Editor, Contract Pharma 04.23.21
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Breaking News | Drug Development | Drug Discovery
KemPharm Receives $10M Milestone for FDA Approval of Azstarys
Is eligible to receive an additional near-term $10 million milestone payment following DEA scheduling of SDX.Charles Sternberg, Assistant Editor 04.22.21
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Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News
Valneva Focuses on Bilateral Discussions to Supply COVID-19 Vax
Looks to secure a supply agreement for the only inactivated vaccine candidate in clinical trials against COVID-19 in EU.Kristin Brooks 04.22.21
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CRO News
PRA Health Sciences Expands Pharmacovigilance Services
Offers post-marketing services for authorized COVID-19 vaccines and therapeutics, including PASS using Real World Solutions.Kristin Brooks 04.22.21
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Industry News
Carton Service Launches Custom Green Packaging Solutions
New brand, Cartons 4R Earth, uses materials that are both more sustainable and renewable.
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Biologics, Proteins, Vaccines | Clinical Trials | Trials & Filings
Valneva’s Inactivated, Adjuvanted COVID-19 Vax Achieves Positive Data
VLA2001 was highly immunogenic with more than 90% of study participants developing significant levels of antibodies to SARS-CoV-2 virus spike protein.Kristin Brooks 04.22.21
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Breaking News | Industry News
CordenPharma Colorado Enhances Lipid Purification Capacity
Announces another major capital expenditure initiative.Charles Sternberg, Assistant Editor 04.19.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
Resilience Acquires Ology Bioservices
Continues expansion with acquisition of biologics manufacturing company.Tim Wright, Editor, Contract Pharma 04.19.21
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Breaking News | Collaborations & Alliances | Industry News
Kintor, Visum Enter COVID-19 Manufacturing Partnership
To expand proxalutamide manufacturing for treatment of COVID-19 patients.Tim Wright, Editor, Contract Pharma 04.19.21
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Breaking News | Collaborations & Alliances | Industry News | Solid Dosage/Creams/Ointments
Recro, Ensysce Expand Development and Manufacturing Partnership
Additional contract broadens and further strengthens customer product portfolio.Tim Wright, Editor, Contract Pharma 04.15.21
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Breaking News | Industry News | Microbiology
Microbiologics Expands Virology Services
Increases capabilities and capacity to provide anti-infective testing, assay development and biomaterial production services for highly infectious pathogens.Kristin Brooks 04.14.21
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cGMP Manufacture | QA/QC
Ensuring Pharma Manufacturing Quality
How today’s life sciences manufacturers can effectively monitor processes, integrate with sub-contractors and align with regulatory reporting requirements.Kristin Brooks, Contract Pharma 04.14.21
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Analytical Services | Biologics, Proteins, Vaccines | Drug Development | Microbiology
Vetter Development Service
With Vetter, you have a partner you can trust to support you throughout drug product development, clinical manufacturing and regulatory approval.
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Aseptic Processing | Fill/Finish | Parenterals | Process Development | Scale-up/Technology Transfer
Vetter Commercial Manufacturing
Vetter’s decades of experience as a contract manufacturer providing fill & finish for injectable drugs helps deliver results for both large and small companies.
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R&D
Digitalization and the Future of Formulating in Modern R&D Labs
This webinar will focus on the benefits of implementing a true data infrastructure, and the challenges that organizations will face along this journey.04.12.21
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AJILITY: Intelligent Drug Product Manufacturing
The AJILITY platform streamlines your drug product manufacturing program, helping you get lifesaving therapeutics to patients in less time with less complexity.
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Breaking News | Collaborations & Alliances | Drug Delivery | Drug Development | Industry News
Kindeva Drug Delivery and Cambridge Healthcare Innovations Collaborate
Work together to develop and commercialize CHI’s novel dry-powder inhaler product.Charles Sternberg, Assistant Editor 04.07.21
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Breaking News | Industry News | Information Technology
LabVantage Solutions Expands and Improves its Portfolio
Unveils two new solutions and an updated version of its flagship LIMS platform.Charles Sternberg, Assistant Editor 04.05.21
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Biologics, Proteins, Vaccines | Regulatory Affairs
What Will Change at FDA for 2021?
(R)evolution of the industry’s data, catalyzed by changes at FDA and what’s the likely impact to the pharmaceutical industry?Ben Locwin, Contributing Editor, International COVID-19 Advisor, Healthcare Futurist 04.01.21
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Clinical Trials | Drug Development | QA/QC
RBQM Comes of Age: COVID as a Catalyst for Change
Clinical trial conduct has undergone a fundamental shift over the last year – and things will never be the same again.Kristin Brooks, Managing Editor 04.01.21
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Breaking News | Drug Development
Servier Acquires Agios Pharmaceuticals’ Oncology Portfolio
Expands its oncology leadership capabilities in the U.S.Charles Sternberg, Assistant Editor 04.01.21
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Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News
Eloxx Pharmaceuticals Acquires Zikani Therapeutics
Combined company brings complementary Ribosomal RNA-targeted genetic therapy platforms together.Kristin Brooks 04.01.21
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Analytical Services | APIs | cGMP Manufacture | Excipients | Formulation Development | QA/QC | R&D | Solid Dosage/Semi-solids
Enteris BioPharma: Custom Solutions – From Bench to Market
CDMO operations are housed within a 32,000-square-foot, FDA-inspected and cGMP-compliant facility in northern New Jersey.
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APIs | Breaking News | cGMP Manufacture | Industry News
Piramal Pharma to Acquire Indian API Manufacturer Hemmo
Adds peptide API development and manufacturing capabilities for growing number of oncology and metabolic therapies.Kristin Brooks 04.01.21
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Breaking News | Industry News | Promotions & Moves
Vibalogics Updates U.S. Leadership Team
Appoints new CFO, VP of quality and head of process sciences.Charles Sternberg, Assistant Editor 03.31.21
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Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News
Ajinomoto, Bright Peak Enter Immunocytokines Research Pact
Exclusive license agreement to incorporate Ajinomoto Co.’s AJICAP site-specific bioconjugation technology for the development of Bright Peak Immunocytokines.Kristin Brooks 03.30.21
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Biologics, Proteins, Vaccines | cGMP Manufacture
Advanced Analytics Advancing Development of Genetic Vaccines
Leveraging innovative advanced analytical technologies to ensure regulatory compliance in the development and production of novel vaccines.Kristin Brooks, Managing Editor, Contract Pharma 03.29.21
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Drug Delivery | Extractables and Leachables
E&L Considerations for Customized Syringe Delivery Systems
Join James Scull, Ph.D., Scientific Director for Element Life Sciences, to gain a deeper understanding of E&L evaluations of custom drug delivery devices.03.29.21
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Bio News | Biosimilars | Breaking News | cGMP Manufacture | Collaborations & Alliances | Facilities | Industry News
mAbxience Bolsters Biosimilar and CDMO Manufacturing Capacity
Utilizing ABEC Custom Single Run technology to increase flexibility and productivity.Tim Wright, Editor, Contract Pharma 03.25.21
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cGMP Manufacture | Drug Development | Scale-up/Technology Transfer
Fast Track Automation in Pharmaceutical Manufacturing
Drug manufacturers turn to advanced automation technologies and project execution methodologies to reduce time, cost and riskSteve Zarichniak, Technical Solutions Consultant, Honeywell Process Solutions 03.25.21
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Breaking News | cGMP Manufacture | Formulation Development | Industry News
Piramal Pharma Solutions, Plus Therapeutics Ink MSA
Piramal to perform services related to the development, manufacture, and supply of Plus Therapeutics’ RNL-Liposome Intermediate Drug Product.Kristin Brooks 03.24.21
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Breaking News | Collaborations & Alliances | Industry News | Scale-up/Technology Transfer
Plus Therapeutics, Piramal Ink Master Services Agreement
Development, manufacturing and supply deal is for Plus’ Rhenium NanoLiposome intermediate drug product.Tim Wright, Editor, Contract Pharma 03.23.21
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Clinical Trials | Drug Development
Regulatory Practices in a Post-Pandemic World
Envisioning the new normal for clinical development.Dr. Ronan Brown, SVP and Head of Integrated Global Compliance, IQVIA 03.22.21
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Breaking News | Clinical Trials | Drug Development | Trials & Filings
Gilead, Novo Nordisk Expand NASH Alliance
Phase II trial to investigate Novo’s semaglutide and a combination of Gilead’s cilofexor and firsocostat, alone and in combination in cirrhosis due to NASH.Kristin Brooks 03.18.21
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Promotions & Moves
Alcami Appoints Patrick D. Walsh as Chairman and Chief Executive Officer
He succeeds Walter J. Kaczmarek III, who is stepping down as Chief Executive Officer.
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Breaking News | Clinical Trial Materials | Cold Chain Management | Industry News
PCI Pharma Services Expands Cold Chain Clinical Supply Storage
Adds significant capacity and several new cold chain storage conditions, which now include temperatures from controlled room temperature to -80°C.Kristin Brooks 03.16.21
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
Northwest Biotherapeutics Adds Production Capacity at UK Facility
Dendritic cell vaccine production capacity for personalized immune therapies increases from about 4 - 6 patients per month to about 40 - 45 patients per month.Kristin Brooks 03.16.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
Takeda and IDT Support Manufacturing of J&J’s COVID-19 Vaccine
Will make manufacturing capacity available at IDT’s facilities in Germany to manufacture the single-shot COVID-19 vaccine.Tim Wright, Editor, Contract Pharma 03.15.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
Maravai Expands CDMO Capabilities Through TriLink Biotechnologies
Offers end-to-end mRNA production with the launch of TriLink's plasmid DNA manufacturing services.Tim Wright, Editor, Contract Pharma 03.15.21
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Cytotoxics and High Potency Manufacturing | Facilities | Solid Dosage/Creams/Ointments
Outsourcing Solid Dosage Manufacturing
A Q&A with Dan Dobry, head of drug product commercial development at Lonza Pharma & Biotech.Tim Wright, Editor, Contract Pharma 03.12.21
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Clinical Trials | Information Technology
The Evolution of Clinical Research Technology to Support Remote Collaboration
Pioneering change with technology advancements that yield high reward with tolerable risk.Angela Gill Nelms, COO for Florence Healthcare 03.11.21
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Breaking News | Collaborations & Alliances | Drug Development
Selexis SA and BITT Enter Service Agreement
Will develop the cell line for BITR2101, BITT’s lead tumor necrosis factor receptor 2 oncology candidate.Charles Sternberg, Assistant Editor 03.10.21
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Breaking News | Industry News
Generic Version of Symbicort Granted FDA Approval
Product is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD).Charles Sternberg, Assistant Editor 03.09.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
High Purity New England & Univercells Technologies Unveil Bioprocessing Solutions
New highly scalable line of bioreactors designed to ensure seamless scalability from early process development to commercial manufacturing.Tim Wright, Editor, Contract Pharma 03.09.21
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cGMP Manufacture | Process Development | Scale-up/Technology Transfer
Process Intensification: Understanding the Optimal Way to Maximize Productivity
Overcoming challenges of implementation and achieving increased volume, reduced timelines, decreased footprint, lower cost of goods, and increased flexibility.Priyanka Gupta, Head of Market Entry Strategy for Protein Based Therapeutics, Sartorius 03.09.21
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Breaking News | cGMP Manufacture | Industry News | Inspections
Metrics Contract Services Completes Russian Regulatory Inspection
Greenville, NC site approved to make an oncology drug to be marketed in Russia.Tim Wright, Editor, Contract Pharma 03.09.21
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Breaking News | Industry News | Promotions & Moves
Sharp Appoints EU Qualified Person
Names Ria Rhemrev-Boom as its new lead EU Qualified Person (QP) for market release services.Tim Wright, Editor, Contract Pharma 03.09.21
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Clinical Trials | Information Technology
Data Management Trends
Pandemic-fueled patient centricity is creating new challenges and opportunities for data management teams.Deepu Joseph, Global Head & VP of Clinical Data Management 03.05.21
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Combination Products & The CDMO Webinar - Watch Now On-Demand
During this webinar, regulatory and quality experts from Alcami provided insights into combination products and the latest regulatory guidance.
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Breaking News
Fusion Pharmaceuticals Acquires IPN-1087
Expands its pipeline of potent alpha-emitting radiopharmaceuticals.Charles Sternberg, Assistant Editor 03.02.21
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Drug Delivery | Parenterals
Injectable Drug Delivery Trends
How medication trends are driving the shift to patient-friendly drug delivery systems.Peter Soelkner, Managing Director, Vetter 03.01.21
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Breaking News | Collaborations & Alliances | Industry News
Phlow Corp. and USP Form Alliance
Focused on continuous manufacturing to increase supply of essential medicines for U.S. patients.Tim Wright, Editor, Contract Pharma 03.01.21
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Manufacturing Equipment Trends
Andreas Mattern of Syntegon Technology discusses latest technologies being leveraged in manufacturing equipment today.Kristin Brooks 02.25.21
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Bio News | Breaking News | Industry News
High Purity New England Bolsters Biopharma Solutions Services
Launches customizable cell culture bioreactor line.Tim Wright, Editor, Contract Pharma 02.25.21
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Breaking News | Drug Development | Industry News
Cyprium, Sentynl Therapeutics Ink Asset Purchase Agreement
Sentynl acquires CUTX-101 Copper Histidinate for the treatment of Menkes disease for $20 million in upfront and regulatory milestones.Kristin Brooks 02.24.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Facilities | Industry News
Catalent Acquires Delphi Genetics
Launches US plasmid manufacturing site to establish global pDNA development and manufacturing capabilities.Tim Wright, Editor, Contract Pharma 02.23.21
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Breaking News | Industry News | Information Technology
Antares Vision Agrees to Acquire rfXcel Corporation
rfXcel’s AI-enabled SaaS platform more than doubles Antares Vision’s software business and adds a high share of contracted, recurring and scalable revenues.Charles Sternberg, Assistant Editor 02.19.21
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Breaking News | Collaborations & Alliances | Drug Development
Lilly, Rigel Enter Exclusive CNS Development Collaboration
Lilly will pay $125 million upfront and up to $835 million in potential milestones for Rigel's lead RIPK1 inhibitor, R552.Kristin Brooks 02.18.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
Novavax, SK Bioscience Expand Vax Pact
The existing partnership for manufacture of NVX-CoV2373 has been expanded to increase production capacity and supply vaccines to the Korean Government.Charles Sternberg, Assistant Editor 02.17.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
Kaneka Eurogentec Expands Capabilities
Receives GMP accreditation for new mRNA manufacturing facility, COVID-19 vaccine production ongoing.Tim Wright, Editor, Contract Pharma 02.17.21
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Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development
Biomunex, Onward Ink Strategic Antibody Development Pact
Exclusive worldwide license and development agreement will leverage Biomunex' next gen bi- and multi-specific antibody platform in hematological malignancies.Kristin Brooks 02.16.21
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Biologics, Proteins, Vaccines | Collaborations & Alliances | Drug Development
Molecular Templates, BMS Enter Strategic Research Pact
Aims to discover and develop multiple therapies for specific oncology targets utilizing MTEM’s next-gen engineered toxin body (ETB) platform.Kristin Brooks 02.11.21
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Breaking News | Facilities | Industry News
Scapa Healthcare Enhances OTC Drug Manufacturing Capabilities
Makes multimillion dollar investment at its Knoxville facility.Tim Wright, Editor, Contract Pharma 02.10.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development | Industry News
AbbVie, Caribou Ink CAR-T Collaboration
Leverages Caribou's next-generation CRISPR genome editing technology platform and AbbVie's antigen-specific binders.Tim Wright, Editor, Contract Pharma 02.10.21
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Breaking News | Industry News
Lonza to Divest Specialty Ingredients Biz
Allows Lonza to focus on its position in the healthcare industry and to accelerate strategic priorities.Kristin Brooks 02.09.21
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Breaking News | Facilities | Fill/Finish | Industry News | Lyophilization | Parenterals
Argonaut Opens Custom Controls and Standards Facility
Formulation and filling will be performed at a state-of-the-art site in Carlsbad, CA.Tim Wright, Editor, Contract Pharma 02.08.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Clinical Trial Materials | Collaborations & Alliances | Industry News
Catalent, Trizell Enter Cell Therapy Deal
Sign development and manufacturing agreement with for macrophage-based advanced cell therapy.Tim Wright, Editor, Contract Pharma 02.08.21
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Biologics, Proteins, Vaccines | Breaking News | Industry News
CureVac, UK Partner on Vaccines Against SARS-CoV-2 Variants
Aims to mitigate the effects of the pandemic and help prepare against future SARS-CoV-2 outbreaks by working on multiple variant vaccines.Kristin Brooks 02.05.21
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Biologics, Proteins, Vaccines | cGMP Manufacture | Drug Development
The Future of Vaccines and Biologics
Dr. Linda Marbán of Capricor Therapeutics discusses the advances in responding to infectious diseases.Kristin Brooks, Managing Editor, Contract Pharma 02.04.21
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Breaking News | Drug Development | Industry News
Lilly Acquires Asahi Kasei’s Chronic Pain Candidate
To pay $20 million upfront and up to $210 million in potential milestones for AK1780, an orally bioavailable P2X7 receptor antagonist.Kristin Brooks 02.01.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development | Industry News | Information Technology
Cognate BioServices, Nucleus Biologics Form Cell & Gene Therapy Partnership
Will focus on clinical and commercial clients, especially as Cognate expands its business with allogeneic and autologous on-demand cell and gene therapies.Tim Wright, Editor, Contract Pharma 01.29.21
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Aseptic Processing | Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Fill/Finish | Industry News
Novartis Inks Contract Manufacturing Deal for Pfizer-BioNTech COVID-19 Vaccine
Novartis to leverage manufacturing capacity and capabilities to address pandemic, supporting global supply of COVID-19 vaccine.Tim Wright, Editor, Contract Pharma 01.29.21
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Cold Chain Management | Logistics | Supply Chain
Delivering Custom Client Solutions
Cold chain solutions provider Sentry BioPharma Services is able to adapt to meet the diverse needs of its clients.Contract Pharma Staff
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Biologics, Proteins, Vaccines | Breaking News | Drug Development | Drug Discovery | Industry News | Information Technology
Evozyne, Takeda Ink Strategic Protein Design Agreement
Takeda will use Evozyne's evolution-based protein design technology to research and develop proteins for next-gen gene therapies.Kristin Brooks 01.28.21
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Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development
Lilly, Vir, GSK Partner to Evaluate COVID Combo Therapies
Lilly expands BLAZE-4 trial to evaluate bamlanivimab with VIR-7831, two neutralizing antibodies that bind to different epitopes of the SARS-CoV-2 spike protein.Kristin Brooks 01.27.21
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Bio News | Breaking News | Collaborations & Alliances | Fill/Finish | Industry News | Parenterals
Ajinomoto Bio-Pharma, Humanigen Expand Manufacturing Agreement
Ajinomoto will support fill finish for investigational COVID-19 therapeutic, lenzilumab, nearing completion of phase 3 study.Tim Wright, Editor, Contract Pharma 01.27.21
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Clinical Trials | Information Technology
The State of Clinical Trial Technology
Blake Adams of Florence discusses key report findings and the clinical trial software used to support Pfizer’s global COVID-19 vaccine study.Kristin Brooks, Contract Pharma 01.26.21
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Breaking News | Formulation Development | Industry News | Methods Development
Adare Pharma Solutions Opens New Small-Scale Lab
Vandalia, OH lab offers customizable, flexible systems designed to expedite formulation and process development services.Kristin Brooks 01.26.21
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Clinical Trials
The Future of Clinical Trials Series: Part II
Greater awareness will ensure diversity is no longer an afterthought and patients will be at the center of every aspect of clinical research.Jena Daniels, Rasmus Hogreffe, Ingrid Oakley-Girvan, Dr. Michelle Longmire, Medable 01.26.21
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Breaking News | Drug Discovery | Industry News | Preclinical Outsourcing
X-Chem Acquires IntelliSyn and AviSyn
Acquisitions allow the company to offer services for screening, hit validation and lead optimization on existing and new markets.Kristin Brooks 01.26.21
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Breaking News | cGMP Manufacture | Excipients | Industry News
PromoCell Receives EXCiPACT Certification
Manufactures pharmaceutical excipients to GMP standards for tailor-made cell culture media and reagents that fulfill specific regulatory requirements.Kristin Brooks 01.26.21
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Breaking News | Facilities | Industry News | Logistics | Packaging & Tracking
WDSrx Expands Warehouse Network
Pharma logistics company creates national network with expansion to Reno, NV.Tim Wright, Editor, Contract Pharma 01.21.21
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Analytical Services | Laboratory Testing
Improving Product Profitability
Using PAT/QbD/CM as tools to increase profitability of products.Emil Ciurczak, Contributing Editor 01.21.21
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Breaking News | Industry News | Information Technology | Validation
Global Biosciences Co. Selects ValGenesis VLMS
Will digitize the validation service activities for efficient and faster access to validated and safer products across 40 countries.Contract Pharma Staff 01.20.21
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Breaking News | Promotions & Moves
Eisai Appoints Chief Clinical Officer of Oncology Biz
Dr. Richard Woodman has 18 years of pharmaceutical experience in several different functional areas at both large and small biotech organizations.Contract Pharma Staff 01.20.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Collaborations & Alliances | Industry News
Intravacc Completes Project for Provention Bio’s Vax Candidate
Potentially the first preventive vaccine for coxsackievirus B, a risk factor associated with type 1 diabetes and celiac disease.Contract Pharma Staff 01.19.21
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Clinical Trials | Drug Development | Information Technology
Virtual Clinical Trials: The Future of Dermatology Studies
COVID-19 has created lasting impacts for clinical trials and a host of benefits have arisen from the adoption of virtual and hybrid models.Sonja VanWye, RN, MSN, Director, Dermatology Strategy, IQVIA Biotech 01.15.21
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Breaking News | Collaborations & Alliances | CRO News | Industry News
Bioclinica Partners with Ikcon Pharma
Will work together to deliver best-in-class e-clinical solutions to the pharma industry & sponsors.Contract Pharma Staff 01.15.21
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Breaking News | Clinical Trials | CRO News | Industry News
Frontage Bolsters Clinical Services Capabilities
Unveils plans to provide full service human radiolabeled absorption, metabolism, and excretion study capabilities.Contract Pharma Staff 01.15.21
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Your Pre-clinical Toxicology Program Needs a Strategy
At Syngene, we have developed a roadmap across pre-IND, IND and NDA that seamlessly integrate the various pre-clinical studies.
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Chemical Development
Syngene has full value-chain Process Research and Development (PRD) capabilities for NCEs and advanced intermediates.
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Breaking News | Collaborations & Alliances
Charles River Partners with JADE
Expands its biologics testing capabilities geographically and helps to accommodate demand for biologics therapeutics.Contract Pharma Staff 01.14.21
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Commercial Manufacturing
Syngene supports manufacturing of regulatory starting materials, APIs, HPAPI, NCEs and novel advanced intermediates.
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
MilliporeSigma Acquires AmpTec
Expands mRNA capabilities for vaccines, treatments and diagnostics.Contract Pharma Staff 01.07.21
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APIs | Breaking News | cGMP Manufacture | Facilities | Industry News
AmbioPharm Opens New Shanghai Campus
Adds European executive team members working out of new Zurich office.Contract Pharma Staff 01.07.21
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Breaking News
Bioclinica Acquires Saliency
Integrates the company's advanced AI technology into its Imaging Platform.Contract Pharma Staff 01.06.21
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Biologics, Proteins, Vaccines | Breaking News | Industry News
Botanical Solution Inc. to Supply Pharma Grade QS-21 Vaccine Adjuvant
Secures $3.3 million in funding with second round planned for Spring 2021 to bolster growth.Contract Pharma Staff 01.06.21
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The Importance of Food Studies in Pharmaceutical Development
Alternate methods of administering solid oral formulations are necessary to meet the needs of all patients.
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Breaking News | Collaborations & Alliances | Industry News
Angelini Pharma Acquires Arvelle Therapeutics for $960M
Angelini to become a leader in CNS and mental health disorder treatments; opening direct affiliates in France, UK, Nordics and Switzerland by 2022.Contract Pharma Staff 01.05.21
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Drug Development | Industry News | Regulatory Affairs
The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021
A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to "normalcy".Chad Landmon, Michelle Divelbiss and Alex Alfano, Axinn, Veltrop & Harkrider LLP's Intellectual Property and Food and Drug Administration Practice Groups 01.05.21
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
INOVIO, Advaccine Enter Exclusive COVID-19 DNA Vax Pact
Partnership adds Asian manufacturing resource to INOVIO's global manufacturing consortium for INO-4800.Contract Pharma Staff 01.04.21
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Clinical Trials | Drug Development
Impact of Decentralized Trials in Oncology Drug Development
Join us on 2/9 as clinical, regulatory and real-world evidence experts discuss the impact of decentralized trials on the evolution of drug dev in oncology.01.04.21
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Analytical Services | Biologics, Proteins, Vaccines | Clinical Trial Materials | Laboratory Testing
Samsung Biologics Continues to Leverage Digitalization to Optimize Client Experience
Through digital transformation, Samsung Biologics is innovating how they connect with clients, regulatory bodies and industry professionals.
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
BioNTech, Shanghai Fosun Pharma to Supply COVID-19 Vax to China
Sign an agreement to provide 100 million doses of their BNT162 mRNA-based vaccine candidate in 2021.Contract Pharma Staff 12.18.20
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ICP-MS - Leveraging Inductively Coupled Plasma Mass Spectrometry To Its Full Potential
by Chris Williams, Julia Spraul (pictured), and Alyssa McBurney
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APIs | Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News
Aurinia and Lonza Expand Manufacturing Partnership
Form agreement for voclosporin manufacturing capacity.Contract Pharma Staff 12.16.20
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Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News | Information Technology | QA/QC
CDMO Cognate BioServices Teams Up with L7 Informatics
To implement L7|ESP for integrated manufacturing and lab operations.Contract Pharma Staff 12.16.20
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Bio News | Bioanalytical Services | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Facilities | Industry News | Process Development | Scale-up/Technology Transfer
CHA Biotech Launches Global CDMO Biz
Matica Biotechnology to construct GMP facility for viral vector production in Texas.Contract Pharma Staff 12.16.20
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Bio News | Breaking News | Collaborations & Alliances | Industry News | Information Technology | QA/QC
Samsung Biologics Adopts Veeva Vault QMS to Unify Quality Management
CDMO is managing quality processes and content for greater visibility and compliance across global manufacturing.Contract Pharma Staff 12.16.20
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Cold Chain Management | Logistics
COVID-19 Vaccine Distribution: The Air Cargo Industry’s Greatest Challenge
How the air cargo logistics community is embracing technology to close critical gaps in the cold chain.Chris Jones, EVP, Marketing and Services, Descartes 12.15.20
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Breaking News | Industry News
AstraZeneca to Acquire Alexion in $39B Deal
Expands scientific presence in immunology by adding Alexion's innovative complement-technology platforms and strong pipeline, and top seller Soliris.Contract Pharma Staff 12.14.20
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Clinical Trials | Drug Development | Information Technology
Advancing Digital Endpoints in Clinical Trials
An end-to-end approach to managing wearable devices through clinical development.Kristin Brooks, Contract Pharma 12.14.20
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Clinical Trials | Information Technology
Life Sciences Strive for Greater Agility
Embracing real-time drug safety monitoring during and post COVID will continue to propel the industry forward.Ronan Brown, SVP of Integrated Technology & Compliance, and Joe Rymsza, VP, Global PV & Regulatory Technology Solutions, IQVIA 12.14.20
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Breaking News | Promotions & Moves
ApiJect Systems Appoints General Counsel & Chief Compliance Officer
James A. Garrett joins the company with extensive legal and strategic business expertise.Contract Pharma Staff 12.14.20
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Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News
Orgenesis, Cure Therapeutics Form JV
Aims to advance point-of-care development and commercialization of cell and gene therapies.Contract Pharma Staff 12.10.20
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Biologics, Proteins, Vaccines | Breaking News | Industry News
Boehringer to Acquire NBE-Therapeutics in €1.2B Transaction
Gains iADC platform and potential best-in-class antibody-drug conjugate (ADC) therapies for the treatment of solid tumors.Contract Pharma Staff 12.10.20
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Breaking News | Industry News | Trials & Filings
Health Canada Authorizes Pfizer, BioNTech COVID-19 Vax
Pfizer Canada and BioNTech will supply the Government of Canada a minimum of 20 million doses and up to 76 million doses of the vaccine through 2021.Contract Pharma Staff 12.10.20
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
Health Canada Green Lights COVID-19 Vax
Canadian regulator authorizes supply and emergency use of Pfizer and BioNTech’s COVID-19 mRNA vaccine.Contract Pharma Staff 12.09.20
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Breaking News | Excipients | Industry News | Parenterals
Evonik Bolsters Excipients Portfolio
Acquires Birmingham-based Lactel absorbable polymers from Durect Corporation.Contract Pharma Staff 12.09.20
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Breaking News | cGMP Manufacture | Industry News | QA/QC | Validation
UK’s VMIC to Implement Lonza’s MODA-EM
To digitize its Microbiology Quality Control operations.Contract Pharma Staff 12.08.20
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Breaking News | Facilities | Industry News | Information Technology
Samsung Biologics Launches Virtual Showroom
Provides key features and real-time construction updates of its recently announced Plant 4.Contract Pharma Staff 12.07.20
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
Tubulis, WuXi Biologics and WuXi STA Form Strategic Pact
Will advance a new generation of antibody-drug conjugates towards clinical evaluation.Contract Pharma Staff 12.03.20
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Trials & Filings
Pfizer, BioNTech Win First Authorization for COVID-19 Vax
MHRA authorizes supply of BNT162b2 vaccine for emergency supply; companies are ready to deliver the first doses to the U.K. immediately.Contract Pharma Staff 12.02.20
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Fujifilm Launches Sterile Express Media Service
Enables manufacturers to test the feasibility of formulations before scale-up to more costly GMP manufacturing.Contract Pharma Staff 12.01.20
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Pfizer, BioNTech Submit CMA for Covid-19 Vax to EMA
Approval could potentially enable the use of BNT162b2 in Europe before the end of 2020.Contract Pharma Staff 12.01.20
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Breaking News | Clinical Trials | Industry News
SGS Initiates U.S. COVID-19 Clinical Trials
Phase 2/3 trial will examine the safety, tolerability, and efficacy of Sarconeos (BIO101) to treat COVID-19 related respiratory failure.Contract Pharma Staff 11.30.20
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Drug Delivery | Drug Development
Inhaled Drug Delivery Technology Trends
The success of new inhaled medicines relies on the correct combination of formulation and device technology.Dr. Sandy Munro, Vice President – Pharmaceutical Development, Vectura 11.24.20
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
AstraZeneca’s AZD1222 Meets Primary Endpoint in COVID-19
Two different dosing regimens demonstrated efficacy with one showing vaccine efficacy of 90% with no serious safety events noted.Contract Pharma Staff 11.23.20
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Breaking News | cGMP Manufacture | Industry News
Catalent, Blueprint Enter GAVRETO Commercial Supply Pact
Following FDA approval and tech transfer, the Catalent team in Kansas City will support commercial supply of the non-small cell lung cancer drug.Contract Pharma Staff 11.23.20
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Breaking News | Industry News | Promotions & Moves
Frontida BioPharma Appoints EVP Technology
Dr. Praful Agrawala brings years of pharmaceutical product development leadership experience to the company.Contract Pharma Staff 11.20.20
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Collaborations & Alliances | Industry News
Pfizer and BioNTech to Submit EUA for COVID-19 Vaccine
Expect to produce globally up to 50 million doses in 2020, up to 1.3 billion doses by the end of 2021; ready to distribute within hours after authorization.Contract Pharma Staff 11.20.20
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Bio News | Breaking News | Collaborations & Alliances | Industry News
Samsung Biologics Partners with Eli Lilly
Accelerates the delivery of Covid-19 antibody treatments.Contract Pharma Staff 11.20.20
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Breaking News | Facilities | Industry News
Comar Breaks Ground in Vineland, NJ
New 159,000 square-foot site will house injection molding machines, proprietary automation, and packaging equipment.Contract Pharma Staff 11.18.20
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Breaking News | Industry News | Information Technology | Promotions & Moves
Sharp Implements Cloud-Based QMS
Strengthens quality leadership with new appointments.Contract Pharma Staff 11.18.20
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Trials & Filings
Pfizer, BioNTech Conclude Phase III COVID-19 Vax Study
Meets all primary efficacy endpoints, demonstrates BNT162b2 to be 95% effective against COVID-19.Contract Pharma Staff 11.18.20
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Excipients
Bye-Bye China?
Instead of closing its doors on China, Western pharma industry needs to take a balanced approach and perform proper due diligence based on objective criteria.Michele Jermini and Enrico Polastro 11.17.20
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Collaborations & Alliances | Drug Development
XOMA Earns $2M Takeda Milestone
Mezagitamab advances into Phase 2 development in generalized myasthenia gravis.Contract Pharma Staff 11.17.20
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Information Technology | Supply Chain
The Pandemic & The Pharma Industry: 3 Things to Know
The importance of vendor contract visibility, an increase in intense legal scrutiny, and new technology for greater agility and control.Colin Earl, CTO at Agiloft 11.16.20
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Capsules | Solid Dosage/Creams/Ointments | Solid Dosage/Semi-solids
Double-blinding and removing bias with over-encapsulation
While there are many blinding options available, over-encapsulation remains the most popular method adopted by sponsors to meet regulatory demands.
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Breaking News | Collaborations & Alliances | Industry News
Lead Pharma and Roche Enter Collaboration & License Agreement
Will develop oral small molecules to treat immune mediated diseases.Contract Pharma Staff 11.16.20
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Clinical Trials | Information Technology
eCOA: Addressing Barriers to Faster Deployment in Clinical Trials
Clinical Outcome Assessments are an increasingly important tool in clinical research.Paul O'Donohoe, Scientific Lead, eCOA and Mobile Health, Medidata 11.13.20
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Preparing to Adopt Intelligent Label Management
The labeling process is highly complex and constantly in flux, making it ideal for digital transformation, but AI and ML cannot be implemented overnight.Kiran Chinnalla, Associate Director Global Regulatory Affairs, Julian Backhouse, Associate Director Regulatory Technology Product Management, Cham Williams, Associate Director Business Systems , IQVIA 11.13.20
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Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture
CCRM, MIP Partner to Build Biomanufacturing Campus
Aims to establish CDMO ops focused on regenerative medicine-based technologies and cell and gene therapies.Contract Pharma Staff 11.13.20
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Breaking News | Logistics | Packaging & Tracking | Supply Chain
Antares Vision Acquires Adents Traceability Assets
Expands portfolio of software solutions and cloud services for end-to-end traceability.Contract Pharma Staff 11.13.20
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Breaking News | Collaborations & Alliances | Industry News
AzurRx BioPharma Partners with Asymchem
Will develop and produce MS1819 for the treatment of exocrine pancreatic insufficiency.Contract Pharma Staff 11.12.20
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Breaking News | Industry News
Pfizer, BioNTech to Supply 200M Doses of BNT162b2 to EU
Deliveries are anticipated to start by the end of 2020, subject to clinical success and regulatory authorization.Contract Pharma Staff 11.11.20
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Breaking News | CRO News | Industry News | Information Technology
RhoFED Wins BARDA Contract
Will serve to standardize data collection, management, and analysis across BARDA-supported network studies.Contract Pharma Staff 11.10.20
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Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Facilities | Industry News
Novavax Expands Facility to Support Global Vaccine Development
Expands campus with two properties to support vaccine research and development, manufacturing, business operations.Contract Pharma Staff 11.10.20
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Breaking News | Facilities | Industry News | Logistics | Packaging & Tracking | Supply Chain
Pharmaceutical Logistics Company Expands in San Antonio
WDSrx expands into San Antonio providing pharmaceutical warehousing and logistics from 1310 Cornerway Boulevard.Contract Pharma Staff 11.10.20
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Breaking News | Industry News | Laboratory Testing
Dalton Pharma Services Expands Capabilities
Offers extractables and leachables testing services.Contract Pharma Staff 11.10.20
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Drug Delivery | Drug Development | Trials & Filings
Impel NeuroPharma Submits NDA for INP104 in Acute Migraine
Leverages the company’s Precision Olfactory Delivery technology11.09.20
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Breaking News | Drug Development | Promotions & Moves
Inozyme Pharma Appoints SVP, Regulatory Affairs
Dr. Kevin B. Johnson brings over 25 years of experience to the role.Contract Pharma Staff 11.09.20
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Excipients
Pharmaceutical Excipients Market Poised for Growth
The global pharmaceutical excipients market is estimated to surpass $11,944.6 million by 2027.Contract Pharma Staff 11.03.20
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Recent Trends in Noncompliance: Critical Review and Analysis of Recent Regulatory Letters
...11.03.20
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Bio News | Breaking News | Collaborations & Alliances | Industry News
TFF Expands Engagement with Experic
Agrees to install a TFF processing line and its associated capabilities at Experic’s cGMP facility in NJ.Contract Pharma Staff 11.03.20
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Breaking News | Industry News
Samsung Biologics, Checkpoint Therapeutics Expand Cosibelimab Mfg. Pact
Samsung Biologics will provide additional commercial-scale drug substance manufacturing.Contract Pharma Staff 11.02.20
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Bio News | Breaking News | Collaborations & Alliances | Industry News
Lonza to Manufacture AstraZeneca's COVID-19 Long-Acting Antibody Combination
cGMP manufacturing of the two long-acting antibodies to begin in H1 2021 at Lonza's Portsmouth, NH (USA) site.Contract Pharma Staff 10.30.20
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Breaking News | Clinical Trials | CRO News
BARDA Reselects ICON as Preferred Partner
Continues as part of BARDA’s exclusive Medical Countermeasures Clinical Studies NetworkContract Pharma Staff 10.29.20
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Breaking News | Industry News | Promotions & Moves
Valicare Expands Service Portfolio
Recruits Dr. Christin Erbach as senior GMP consultant.Contract Pharma Staff 10.28.20
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News | R&D
Sai Life Sciences to Expand Biology Capabilities
Begins construction of new 75,000 sq. ft. facility in Hyderabad; adding 170 biologists to team.Contract Pharma Staff 10.28.20
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The Future of Pharmaceutical Manufacturing: Multi-Product Facility and Equipment Design
Join us for a FREE webinar on November 12 at 11:00 AM EST.10.26.20
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Breaking News | Collaborations & Alliances
Elsevier, Novartis Collaborate on Risk Assessment Prediction Tool
To develop a safety margin risk assessment prediction tool, largely using PharmaPendium data.Contract Pharma Staff 10.22.20
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Breaking News | cGMP Manufacture | Drug Development | Industry News
Roche, Atea Pharma to Develop Potential Oral COVID-19 Treatment
To develop, manufacture and distribute AT-527, Atea’s investigational oral direct-acting antiviral being studied to treat COVID-19.Contract Pharma Staff 10.22.20
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Breaking News | Industry News | Packaging & Tracking | Serialization
TraceLink Launches Serialized Product Intelligence Solution
Allows companies to proactively monitor their serialized operations and gain actionable insights to avoid costly delays and ensure product availability.Contract Pharma Staff 10.21.20
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Aseptic Processing | Breaking News | Collaborations & Alliances | Facilities | Fill/Finish | Industry News | Parenterals
CDMO QCL Expands Fill Finish Capabilities
Partners with AST on flexible, isolated fill finish equipment for new facility expansion.Contract Pharma Staff 10.21.20
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Clinical Trials | Drug Development | Preclinical Outsourcing
Accelerating R&D Trends
The pandemic has propelled lingering trends into the forefront and increasingly complex molecules and biologics have drug developers outsourcing more.Kristin Brooks, Contract Pharma 10.20.20
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Breaking News | Clinical Trials | Collaborations & Alliances
Cytocom and Cleveland Biolabs Merge
Combine their businesses in an all-stock transaction.Contract Pharma Staff 10.20.20
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Breaking News | Clinical Trials
Mereo Makes Leadership Changes
Appoints CFO and SVP, regulatory affairs.Contract Pharma Staff 10.20.20
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Breaking News | cGMP Manufacture | Collaborations & Alliances | Facilities | Industry News
GSK to Sell Poznań Manufacturing Site to Delpharm
The CDMO acquires all facilities and gains approximately 700 manufacturing employees.Contract Pharma Staff 10.15.20
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Aseptic Processing | Fill/Finish
A Holistic Cleanroom Concept: Higher Quality and Greater Flexibility
Overcoming today’s aseptic fill-and-finish process challenges.Ute Schleyer, Project Manager, Site & Plant Development, Vetter 10.14.20
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The Changing Approach to Design: Five Ways to Achieve Warp Speed
Revisiting facility design and construction based on today’s biopharmaceutical industry needs.Jarrod Wrampe, Contributing Editor 10.14.20
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Analytical Services | Bioanalytical Services | Breaking News | Industry News | Laboratory Testing
PPD to Open Multipurpose Clinical Research Lab in Suzhou
Will offer bioanalytical, biomarker and vaccine services for global and China-based biopharma customers.10.14.20
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Biologics, Proteins, Vaccines | Breaking News | Industry News
MilliporeSigma Launches VirusExpress Platform
Scalable platform increases dose yields and reduces process development time for cell and gene therapies.10.13.20
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Breaking News | Collaborations & Alliances | Industry News | Information Technology
U.S. Govt. Selects LabVantage’s LIMS
Walter Reed Army Research Inst. will use LIMS to support the production of vaccines for COVID-19 and other diseases.Contract Pharma Staff 10.13.20
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Clinical Trials | Information Technology
Adding Remote Site Access to Sponsor Bids: What to Know as CRO
Traditional monitoring has changed, CROs should build a portfolio of remote access solutions and have them ready.Ryan Jones, CEO, Florence Healthcare 10.13.20
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Drug Delivery
Topical Drugs Poised for Growth
The topical drug delivery market is projected to reach $129.8 billion by 2025 from $95.2 billion in 2020, at a CAGR of 6.4%.Contract Pharma Staff 10.12.20
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Biologics, Proteins, Vaccines | Breaking News
FDA Issues Guidance on EUA for COVID-19 Vaccines
Provides further information on the EUA process for investigational vaccines.Contract Pharma Staff 10.07.20
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Breaking News | Promotions & Moves
Tergus Pharma Expands Executive Leadership
Appoints VP of quality and VP of manufacturing.Contract Pharma Staff 10.06.20
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Breaking News | Collaborations & Alliances | Industry News | Information Technology
Zenith Technologies Collaborates with Ideagen
Adopts Ideagen’s Q-Pulse eQMS software to improve performance visibility.Contract Pharma Staff 10.06.20
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Breaking News | Clinical Trial Materials | Collaborations & Alliances | Industry News | Preclinical Outsourcing
Ocugen Engages Kemwell Biopharma for cGMP Manufacture of OCU200
Paves the way towards getting OCU200 in the clinic by first half of 2022.Contract Pharma Staff 10.06.20
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Parenterals
Primary Packaging Considerations Amid COVID-19 Vax Urgency
Fran L. DeGrazio of West discusses why and how vaccine development is different than drug development and the impacts of COVID-19 on vaccine development.Kristin Brooks, Contract Pharma 10.05.20
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Breaking News | Collaborations & Alliances | Drug Development
Diamond Pharma Services Supports GenSight Biologics
Provides EU regulatory, pharmacovigilance, quality and compliance support for LUMEVOQ.Contract Pharma Staff 10.05.20
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Breaking News | Drug Development | Industry News | Information Technology
Dr. Reddy's Goes Paperless with ValGenesis VLMS
Digitizes validation process across multiple sites leveraging ValGenesis electronic validation lifecycle management system.Contract Pharma Staff 10.05.20
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Breaking News | Promotions & Moves
3P Expands Management Team
Adds José Luis Bartolomé as operational excellence and continuous improvement director.Contract Pharma Staff 10.02.20
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Breaking News | cGMP Manufacture | Fill/Finish | Industry News
CRB Completes Large-Scale Mfg. Facility for GRAM
GRAM's newest facility was designed to increase its large-scale fill and finish capacity for COVID-19 vaccines and therapeutics.Contract Pharma Staff 10.01.20
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Breaking News | Promotions & Moves
Aphena Appoints Quality and Regulatory Affairs VP
Matthew Prokopczyk brings 25 years of experience in the pharmaceutical industry in the areas of quality control, regulatory compliance and quality assurance.Contract Pharma Staff 09.30.20
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Breaking News | Facilities | Industry News
Vetter Opens New Training Center
In September 2020, Vetter trainees started learning and working in the new Vetter training center.Contract Pharma Staff 09.18.20
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Breaking News | Promotions & Moves
Aprecia Appoints Regulatory Affairs SVP
Kathi Rinesmith to oversee strategic regulatory affairs for the company's expanding pipeline of 3D-printed pharmaceuticals.Contract Pharma Staff 09.17.20
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Aseptic Processing | Drug Development
Why is the sterility of your drug product much more than just a test of sterility?
Join Contract Pharma and Nelson Labs for a FREE webinar on Wednesday, October 21 at 1:00 PM EDT to learn more.09.16.20
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Aseptic Processing | Lyophilization
Planning and Executing a Media Fill: A Guide to Aseptic Process Validation for Lyophilized Products
This webinar from Lubrizol Life Science on Nov 4 will explore key considerations in designing and executing aseptic process simulations for lyophilized products09.10.20
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Biologics, Proteins, Vaccines | Breaking News | Promotions & Moves
Harpoon Therapeutics Appoints VP, Regulatory Affairs and Quality Assurance
Karin Ann Thacker brings 20 years of leadership experience.Contract Pharma Staff 08.27.20
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Biopharmaceutical Manufacturing under Regulatory Compliance: Process Strategies, CGMP Considerations
...08.20.20
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Breaking News | Industry News | QA/QC
Rx-360 Expands Audit Program
Adds remote auditing and new checklists.Contract Pharma Staff 08.12.20
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APIs | cGMP Manufacture | Clinical Trials | Supply Chain
Evaluating Pharma Amid COVID-19
Dr. Ural of Ernst & Young LLP discusses market dynamics, enduring therapeutic areas, near term M&A, and how industry can use this time for transformationKristin Brooks, Contract Pharma 05.18.20
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Clinical Trials
Pioneering Medicine Forward
May 20th marks Clinical Trials Day, celebrating 273 years of clinical trialsTina Bland, Senior Consultant, KCR Trial Execution Consulting 05.18.20
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cGMP Manufacture | Clinical Trials | Drug Development | Information Technology | R&D
COVID-19’s Long-Term Impact on Drug Development: The New Pragmatism
The rise of new tools and approaches, an increase in regulatory responsibility, and the need for speed.Paul Bridges SVP Worldwide Head Regulatory & Access, Parexel and Sheela Hegde, Partner and Managing Director, Health Advances 05.18.20
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Bio News | Breaking News | Collaborations & Alliances | Industry News
bluebird bio Amends CAR-T Collaboration
Bristol Myers Squibb assumes responsibility for vector manufacturing in ex-U.S. territoriesContract Pharma Staff 05.18.20
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
WuXi Launches CAR-T Cell Therapy Platform
Will enable biotechnology companies and researchers to accelerate the development, manufacturing and release of cell and gene therapies for patientsContract Pharma Staff 05.18.20
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Breaking News | Facilities | Industry News | Inspections
PharmaCyte Conducts Final Audit of Mfg. Facility
Batch records in Thailand have been deemed cGMP compliantContract Pharma Staff 05.18.20
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Breaking News | Drug Development | Drug Discovery | Industry News | Information Technology | Laboratory Testing | R&D
Pistoia Alliance Launches Toolkit for FAIR Data Principles
Backed by major pharma, the toolkit aims improve data management and data sharing, supporting AI and machine learning to advance the Lab of the Future.Contract Pharma Staff 05.15.20