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Coriolis Pharma
Company Headquarters
18B Fraunhoferstraße
Planegg, BY 82152
Germany
Contract Service Directory
- Accelerated Stability Studies
- Analytical Methods Development
- Contract Research
- Forced Degradation Studies
- Formulation Development
- Gene Therapy & Testing Protocols
- Lyophilization
- Methods Development
- Particle Characterization
- Pilot-Scale Filling
- Preclinical Testing Formulations
- Preformulation
- Quality Control Testing
- R&D Services
- Stability Studies
Contract Services Directory
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Chemical Development
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Oligonucleotides
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![[VIRTUAL LAUNCH] Redefining Virus Manufacturing with NevoLine™ Upstream](https://dev.rodpub.com/images/224/959_thumb.jpg)
[VIRTUAL LAUNCH] Redefining Virus Manufacturing with NevoLine™ Upstream
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Breaking News | cGMP Manufacture | Industry News
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Breaking News | Drug Development
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Fujifilm Launches Sterile Express Media Service
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Promotions & Moves
Catalent Appoints Open Innovation, Biologics, Cell and Gene Therapy VP
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Asahi Kasei Pharma Contracts ProBioGen
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
CEVEC, Roche Ink ELEVECTA Technology License Agreement
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Taysha Gene Therapies Partners with Catalent
Rapidly expands Taysha’s manufacturing capacity.Contract Pharma Staff 11.05.20
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Breaking News | Collaborations & Alliances | Drug Development | Industry News
Sensorion and Novasep Sign Agreement
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Bio News | Breaking News | cGMP Manufacture | Industry News
eTheRNA Extends mRNA Production Services
Adds high throughput research grade mRNA to its GMP capabilities.Contract Pharma Staff 11.03.20
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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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Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances
REGENXBIO Achieves $80M Novartis Milestone
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
CEVEC, Rznomics Ink License Agreement for CAP Technology
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Bio News | Breaking News | Facilities | Industry News
CellGenix Expands Facility
Meets the growing demand for GMP raw materials.Contract Pharma Staff 10.13.20
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Breaking News | Collaborations & Alliances | Drug Development
Orgenesis to Acquire Koglio Therapeutics
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Bio News | Breaking News | Facilities | Industry News
Arranta Bio Establishes Commercial-Ready Manufacturing Facility
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Breaking News | cGMP Manufacture
BioLife Solutions Acquires SciSafe
Enables BioLife to offer more value to its cell and gene therapy customers.Contract Pharma Staff 09.21.20
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Breaking News | Collaborations & Alliances | Industry News
Axovant Partners with Viralgen
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Breaking News | Industry News
Univercells Introduces NevoLine Upstream Platform
A low-footprint manufacturing platform suitable for multiple viral applications.Contract Pharma Staff 09.16.20
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Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News
Cobra Biologics and CombiGene Partner
Sign agreement to secure GMP production of plasmids for production of CG01 gene therapy.Contract Pharma Staff 09.10.20
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Breaking News | Clinical Trial Materials | Collaborations & Alliances | Industry News
JanOne Prepares for GMP Production
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Bio News | Breaking News | Facilities | Industry News
Luina Bio Expands
Announces new bio-manufacturing GMP and development facilities.Contract Pharma Staff 09.01.20
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Cobra Produces Master Cell Banks for CombiGene’s Gene Therapy
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Breaking News | cGMP Manufacture | Industry News
Catalent’s Harmans Site Approved to Manufacture AveXis’ Gene Therapy
To produce commercial drug substance intermediate for AveXis’ spinal muscular atrophy gene therapy at its manufacturing facility in Harmans, MD.Contract Pharma Staff 08.07.20
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Breaking News | Cold Chain Management | Industry News | Packaging & Tracking
Medipal Holdings Partners with Cryoport
Will bring temperature-controlled supply chain solutions to the Japanese market.Contract Pharma Staff 08.06.20
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
CPI Collaborates with MicrofluidX and CGT Catapault
Aims to reduce the time and cost of bringing novel cell and gene therapies to market.Contract Pharma Staff 07.29.20
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Bio News | Breaking News | Collaborations & Alliances | Drug Development | Industry News
Ovid and UConn Enter Strategic Research Collaboration
Aim to accelerate the development of next-gen genetic therapy for Angelman Syndrome.Contract Pharma Staff 07.23.20
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Breaking News | Collaborations & Alliances
PTC Agrees to Monetize Risdiplam Royalty Stream
Plans to further develop and expand its rare disorder portfolio.Contract Pharma Staff 07.20.20
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Biologics, Proteins, Vaccines | cGMP Manufacture | Drug Development
Tackling Analytical Challenges in Gene Therapy
Key considerations on how to navigate the field as a gene therapy developer.Khanh Ngo Courtney, Ph.D., Biologics Project Director, Avomeen 07.17.20
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Bio News | Breaking News | Collaborations & Alliances | Industry News
Orgenesis Enters Collaboration Agreement with Educell
Will conduct collaborative cell-based research projects in Europe.Contract Pharma Staff 07.14.20
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Breaking News | Facilities | Industry News
Gemini Bio Opens New cGMP Facility
Quadruples manufacturing capacity.Contract Pharma Staff 06.22.20
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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 | Collaborations & Alliances
Ori Biotech and CellGenix Collaborate
Promote innovation within closed-system cell and gene therapy manufacturing.Contract Pharma Staff 05.13.20
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Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
Key Biologics and Astarte Biologics Rebrand
Will now be known as CelleroContract Pharma Staff 05.12.20
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Bio News | Breaking News | Collaborations & Alliances | Industry News
Sarepta and Dyno Therapeutics Will Develop Next-Gen Gene Therapy Vectors
Dyno’s proprietary CapsidMap platform opens up new ways to identify novel capsidsContract Pharma Staff 05.12.20
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Breaking News | Industry News | Promotions & Moves
Alcami Makes Senior Leadership Appointments
Sally Langa to lead biz dev efforts; Kimberly McClintock returns to head-up marketingContract Pharma Staff 05.08.20
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Breaking News | Collaborations & Alliances | Industry News
Avrobio and Magenta Therapeutics Collaborate
Evaluate targeted antibody-drug conjugate as a potential conditioning regimen for lentiviral gene therapiesContract Pharma Staff 05.06.20
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Bio News | Breaking News | Collaborations & Alliances | Industry News
Avid and Aragen Launch “Sequence-to-Manufacturing” Service
Designed to drive efficiencies and reduce overall timelines for delivering early-stage CGMP bulk drug substancesContract Pharma Staff 05.06.20
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Bio News | Biologics, Proteins, Vaccines | cGMP Manufacture | Clinical Trial Materials | Scale-up/Technology Transfer
NJII Names BioCentriq as Cell & Gene Therapy Mfg. Center
Newark, NJ process development and clinical manufacturing facility for cell and gene therapies becomes first of its kind located on a U.S. university campus.
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Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News
Nanoform Awarded GMP Certification
To manufacture investigational drug developed using its CESS nanoparticle engineering platform for use in clinical trials.Contract Pharma Saff 05.05.20
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Breaking News | Promotions & Moves
Catalent Appoints Cell & Gene Therapy President
Manja Boerman will lead all of Catalent’s cell & gene therapy businesses worldwide.Contract Pharma Staff 05.01.20
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New iPSC Master Cell Banks to Accelerate Development of Novel Cell Therapies
panCELLa and CCRM collaborate to benefit academia and industry
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Drug Development
Major Drug Approvals of 2019
Abbvie, Novartis, Pfizer and J&J score big wins with blockbuster potentialKristin Brooks, Contract Pharma 02.24.20
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Animal component free (ACF) media development for cell therapies
ACF media achieved comparable performance to serum containing
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THE CENTRE FOR CELL AND VECTOR PRODUCTION (CCVP)
A Transparent and Flexible Approach to Manufacturing
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Centre For Cell And Vector Production
A fully functional 20,000 sq. ft. GMP facility featuring 10 ISO Class 7/Grade B clean rooms to enable production of cells and viral vectors for Phase I and II clinical trials.
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Breaking News | Clinical Trial Materials | Drug Delivery | Industry News
Phillips-Medisize Expands Clinical Mfg. Capabilities
The facility is designed to support late stage development of medium- and high-volume products and processes under GMP01.10.20
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Breaking News | Industry News | Promotions & Moves
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Facilities | Industry News
Genethon, Sarepta Choose Yposkesi as Mfg. Partner
CDMO’s capacity to produce AAV materials at large-scale will support Genethon and Sarepta’s project to take micro-dystrophin to clinical trials this year.01.09.20
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News | Information Technology
iBio, EdgePoint AI Form Biologics Partnership
Collaborate for next gen quality in biologics manufacturing.01.07.20
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Breaking News | Promotions & Moves
CARsgen Therapeutics Appoints Global Regulatory Affairs SVP
Dr. Fan will be responsible for CARsgen global regulatory strategy, leading the U.S. and China regulatory affairs team01.06.20
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Planning for Commercial Success
Best Practices for Designing Cell & Gene Therapy Clinical Trails
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
Genopis Launches GMP Contract Mfg. Business
New CDMO to offer plasmid DNA production in Q2 of 2020.01.03.20
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Drug Development | R&D
Top Pharma M&A Deals of 2019
Drug manufacturers spent a record $342 billion on Mergers & AcquisitionsKristin Brooks, Contract Pharma 12.23.19
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News | Scale-up/Technology Transfer
AGC Biologics Expands Plasmid DNA Offering
pDNA is key for gene therapy applications for the creation of Lentivirus and Adeno-associated viruses as well as direct gene therapy12.17.19
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Breaking News | cGMP Manufacture | Cold Chain Management | Industry News | Supply Chain
Symbiosis Invests $1.9M in UK Facility Expansion
Doubles current footprint at Stirling site with an additional 8,000 sq.-ft. of space12.16.19
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Breaking News | CRO News | Facilities | Industry News
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
Avantor Boosts Biopharmaceutical Innovation in China
Opens innovation and customer support center in Shanghai.12.11.19
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Breaking News | Drug Development | Promotions & Moves
Locana Appoints CEO
James Burns is an accomplished company builder and biopharmaceutical product developer12.10.19
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Bio News | Bioanalytical Services | Biologics, Proteins, Vaccines | Breaking News | Industry News
Sartorius Expands Cell Culture Media Capabilities
Pays $45 million for a majority stake in cell culture media specialist Biological Industries.12.09.19
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Biologics, Proteins, Vaccines | Breaking News | Industry News
Novasep Launches oXYgene for Boosting Viral Vector Production
A unique 2-year turnkey plant offer to accelerate commercial production of viral vectors.12.05.19
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Breaking News | cGMP Manufacture | Industry News
Thermo Fisher Opens $90M Viral Vector Mfg. Site
The facility will create 200 new jobs and support the development, testing and manufacture of viral vectors.12.05.19
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Breaking News | Cold Chain Management | Industry News | Logistics | Supply Chain
CSafe Global Expands Packaging Portfolio
AcuTemp Plus Series aims to address temperature-controlled shipping needs of commercial pharmaceuticals, clinical trials, and cell and gene therapies12.03.19
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Breaking News | cGMP Manufacture | Clinical Trial Materials | GMPs/GCPs | Industry News
CureVac Granted Mfg. Authorization for GMP Production Suite
GMP Production Suite scales up capacity for preclinical, clinical and early launch needs for proprietary and partnered programs12.03.19
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Aseptic Processing | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
Polyplus-transfection Expands GMP Portfolio
New GMP conditioning of PEIpro-GMP designed to support clinical phase and commercialization stages of production12.03.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
Lonza and DiNAQOR AG Enter Gene Therapy Collaboration
Lonza’s manufacturing site in Houston, TX will handle all product supply for DiNA-001.11.28.19
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Breaking News | Cold Chain Management | Industry News | Packaging & Tracking | Supply Chain
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Biologics, Proteins, Vaccines | Drug Development
Immunogenicity Assessment of Gene Therapy Compounds
Dr. Kromminga of BioAgilytix discusses testing challenges and evolving trends in gene therapy.Dr. Arno Kromminga, global chief scientific officer, BioAgilytix 11.27.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
HALIX Opens State-of-the-Art cGMP Facility
New facility for the development and manufacturing of biopharmaceuticals.11.22.19
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What Are the Benefits of an Automated High-Throughput Screening Process for Custom Cell Culture Media Development
We are often asked if culture media development can be customized at the discovery stage of the product, and if feasible, how it can be done.
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Biologics, Proteins, Vaccines | Biosimilars
Biopharma Over 20 Years
A look at the key trends that have impacted the biopharma industry over the years.K. John Morrow, Jr. and Eric S. Langer, BioPlan Associates 11.20.19
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Breaking News | CRO News | Drug Development | Drug Discovery | Industry News | R&D
BASi Launches CRO Rebrand
Inotiv is the new name of its contract research services business.11.20.19
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Bio News | Breaking News | Industry News | Promotions & Moves
Rentschler Biopharma Appoints New Executives to Join U.S. Team
New heads of Process Sciences and Human Resources departments.11.20.19
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Breaking News | Promotions & Moves
Catalent Appoints Corporate Development and Science Leaders
Mike Grippo will serve as senior vice president, Strategy and Corporate Development, and Julien Meissonnier as vice president and chief scientific officer11.19.19
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Biologics, Proteins, Vaccines | Clinical Trials
Advanced Therapies: Adding a New Layer of Complexity to Clinical Trials
Overcoming the challenges of a new and changing clinical trial landscapeErin Finot, Global Head of Immuno-Oncology, IQVIA Biotech 11.18.19
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Breaking News | Facilities | Industry News | Inspections
Metrics Completes Japanese Regulatory Inspection
Marks the first international inspection of the company’s new 126,000-square-foot commercial manufacturing facility constructed in 2018.11.18.19
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Reader Showcase
Thermo Scientific Introduces Handheld IonicX Analyzer
Designed to allow pharma and biopharma manufacturers to verify the identity of ionic salts in the warehouse in seconds11.15.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
Fujifilm Expands Gene Therapy Capabilities
Investing $55mn in gene therapy process and analytical development capabilities with the addition of new dedicated laboratories.11.15.19
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Biologics, Proteins, Vaccines | Excipients
MilliporeSigma Launches New Sucrose Offering
For high risk applications such as injectables and biotherapeutics11.14.19
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Bio News | Bioanalytical Services | Biologics, Proteins, Vaccines | Breaking News | Clinical Trial Materials | Industry News
Arranta Bio Acquires Captozyme
Creates a CoE for microbiome development and clinical supply.11.13.19
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Biologics, Proteins, Vaccines
Cell and Gene Therapy Landscape
Heather Myler of PPD provides current insight into the growing field of Cell and Gene Therapies11.12.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
IDT Biologika, NIH Mfg. Contract Updated
Awarded new task order in the scope of 10-year NIH contract to manufacture vaccines and biologics for infectious diseases.11.11.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
Rentschler Kicks Off Expansion at U.S. Facility
New 500 L bioreactor in operation mid-2020 at U.S. site.11.11.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
Cognate BioServices Acquires Cobra Biologics
Creates global cell and gene therapy manufacturing services platform for both clinical and commercial products.11.11.19
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Breaking News | Cold Chain Management | Industry News | Logistics | Supply Chain
Lonza Selects Cryoport as Preferred Partner
Will work to remove the supply chain hurdles faced by developers of Cell & Gene Therapies11.08.19
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cGMP Manufacture | Drug Development
Contract Pharma’s 20th Anniversary Series: Catalent
Elliott Berger of Catalent shares his insights on the past 20 years and what we can anticipate for the future of the industry and outsourcingKristin Brooks, Contract Pharma 11.08.19
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Breaking News | cGMP Manufacture | Industry News | Information Technology
Werum Releases Next-Gen PAS-X MES
Designed to speed up biotech and cell and gene manufacturing11.07.19
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Notch Therapeutics – a new company with a revolutionary allogeneic T cell technology
(“off the shelf”)
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Bioanalytical Services | Clinical Trials | Industry News | Laboratory Testing
Recipharm Divests Bioanalysis Biz
Expands existing partnership with CTC Clinical Trial Consultants AB.11.04.19
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Analytical Services | Industry News | QA/QC
Recipharm Launches Recipharm Analytical Solutions
Stand-alone service offers analytical services including method development, method validation, and stability program design and implementation11.04.19
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Facilities
Raybow Expands CDMO Business to U.S. with Acquisition of PharmAgra Labs
Planning an expansion project at the PharmAgra site, adding additional capacity and personnel in the Brevard, NC area.11.04.19
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Bio News | Breaking News | Industry News
Nikolaus Rentschler and Frank Mathias are "EY Entrepreneur of the Year"
Rentschler Biopharma management duo received the award on October 25.11.01.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
Bio-Techne Invests in New GMP Manufacturing Facility
Will supply raw materials for cell therapy production.11.01.19
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Five Steps to Ensure Your Cell and Gene Therapy Product Is GMP Compliant
When we think about CGTs what most often comes to mind is the early stage scientific innovation responsible for finding new ways to treat diseases.
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APIs | Breaking News | Facilities | Industry News
Sterling Expands US Operations
Invests $1.5 million into North Carolina facility expansion.10.30.19
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German Pharma Benefiting From a Brexit Boost?
Germany consolidates itself as world leader in pharma according to the CPhI Pharma Index.10.29.19
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Biologics, Proteins, Vaccines | Drug Development
Cell and Gene Therapy for Neurological Product Indications
Panel discusses development and clinical progress for these next-gen treatments for CNS conditions
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Breaking News | Capsules | Facilities | Industry News
CDMO to Invest Over €3M in GMP Facility Expansion
Micro-Sphere will add an additional spray drying line to its facility in Switzerland.10.28.19
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Valsynthese
Custom manufacturer with focus on development and synthesis under GMP and ISO 9001 environment.10.24.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
Aldevron, NTC Team Up for Gene Therapy Manufacturing
To offer Nanoplasmids and antibiotic-free RNA-OUT technology.10.23.19
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Biologics, Proteins, Vaccines
Solvay’s Udel PSU Leveraged to Develop Spaulding Series
Designed to withstand the required operating temperature range of -40°F to 280°F, enabling the aseptic disconnects to be used in cryogenic conditions10.17.19
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cGMP Manufacture | Clinical Trial Materials | Industry News | Scale-up/Technology Transfer
CombiGene, Cobra Biologics Sign Production Pact
Master Service Agreement includes manufacturing of CG01 for clinical studies as well as commercial production upon approval10.16.19
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Clinical Trial Materials
Overcoming the Small Molecule Bioavailability Challenge
Approximately 90% of preclinical compounds are estimated to face bioavailability challenges.David Lyon, Sr. Research Fellow, Lonza Pharma & Biotech 10.15.19
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cGMP Manufacture
Deriving Value from Integrated cGMP and Pre-GMP Manufacturing Operations
The benefits of leveraging a mix of GMP and pre-GMP facilities.Didier Combis, Commercial Director, Seqens CDMO 10.15.19
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Contract Pharma’s 20th Anniversary Retrospective
A look back a the pharma/biopharma industry and the future of outsourcing.Kristin Brooks, Managing Editor, Contract Pharma 10.15.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
Prevail, Lonza Enter Development and Mfg. Alliance
Lonza will manufacture Prevail's AAV-based gene therapy programs for neurodegenerative diseases10.08.19
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Breaking News | GMPs/GCPs | Industry News | Inspections
ASIT biotech Receives GMP Certification
Site in Liège, Belgium to manufacture in-house the active pharmaceutical ingredient of its leading product for grass pollen allergies10.07.19
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Bio News | Breaking News | Collaborations & Alliances | Industry News
Rentschler Expands Collaboration with Summit
New contracts secured with Japanese pharmaceutical companies10.04.19
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Bioanalytical Services | Biologics, Proteins, Vaccines | Industry News | Laboratory Testing
Frontage Expands Bioanalytical Capacity and Capabilities
To add 10,000 square feet of lab space to support biologic drug development, biomarkers and cell and gene therapy10.03.19
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Biopharmaceuticals & Analytical Testing Technology
Analytical technology and processes are evolving as the biologics industry continues to grow.10.01.19
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Biologics, Proteins, Vaccines | Breaking News | Drug Development | Drug Discovery | Industry News
Astellas to Fund Boston-Area Cell and Gene Therapy Start-Up
Invests $12.5 million to support LabCentral Incubators in Boston's Life Science Community10.01.19
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Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Packaging & Tracking
TrakCel, WuXi AppTec Enter Strategic Supply Chain Pact
Aims to accelerate delivery of cell and gene therapies for mutual customers10.01.19
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Breaking News | Industry News | Inspections | Regulatory Affairs
Almac Completes Three Regulatory Inspections
Inspections at Charnwood, Craigavon, and Audubon sites successful09.27.19
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Biologics, Proteins, Vaccines | cGMP Manufacture | Drug Development
Continued and Consistent Investment in Manufacturing Facilities
As companies move their cell and gene therapies through the development process, supporting larger Phase III trials and commercial launches will be a challengeRyan Carpentier, Executive Director of Business Development, Cryoport 09.23.19
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Clinical Trials
Gene Therapy Trials
Applications and the limitations of real-world data.Karen Ooms, Executive Vice President and Head of Statistics, Quanticate 09.16.19
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APIs | Regulatory Affairs | Supply Chain
API Supply Chain Strategy
How to risk-proof your API supply chain for a successful 505(b)(2) filing.Shailesh Vengurlekar and Hamilton J. Lenox, LGM Pharma 09.16.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Facilities | Industry News
GE Healthcare and Germfree to Advance Manufacturing of Novel Biotherapeutics
Manufacturing solution will feature a Germfree modular bioprocessing environment09.16.19
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Breaking News | Industry News | Solid Dosage/Creams/Ointments | Solid Dosage/Semi-solids
Upperton Pharma Solutions Investment Increases Tabletting Capabilities
New Futorque X tablet press is designed to support R&D studies and production batches09.16.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News | Validation
CMAB Receives Positive Opinion Following External Quality Audit
CDMO’s fully integrated facility in Suzhou, China was found to conform to EU Eudralex Vol. 4 GMP guidelines09.10.19
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Bio News | Breaking News | Industry News | Validation
Viralgen Receives EMA cGMP Certification
Confirms commitment to flexible and robust AAV manufacturing capability09.05.19
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cGMP Manufacture | Clinical Trial Materials | Industry News
Rentschler Biopharma Takes on New Projects at Milford, MA Facility
The site will support both clinical and commercial manufacturing programs09.04.19
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iBio, CC-Pharming Expand Collaboration in China
Licenses to iBio’s Bio-Better Rituximab and FastPharming™ System expand commercial partnership08.27.19
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Mustang Bio, CSL Behring Enter License Agreement for Stable Producer Cell Line
Cytegrity™ is a stable producer cell line developed by St. Jude Children’s Research Hospital for the treatment of X-linked severe combined immunodeficiency08.27.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News | R&D
Pfizer Invests $500M in Gene Therapy Facility
The Sanford, NC site to support continuing investment in gene therapy R&D08.21.19
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cGMP Manufacture | Clinical Trial Materials | Industry News | Process Development | R&D
IBBR Seeks RFPs for cGMP Biologics Manufacturing
Facility is also equipped to perform process development research, preclinical manufacturing for IND-enabling tox studies, Point of Concept studies08.19.19
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cGMP Manufacture | Fill/Finish | Industry News | Lyophilization
Thermo Fisher Opens VR Training Center in Greenville
Training Center can train 20 people at a time, with the goal of reducing training time by 50%08.19.19
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Bio News | Breaking News
AskBio Acquires Synpromics
The two companies bring together pioneering technology to increase efficacy of gene therapeutics08.14.19
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Promotions & Moves
Avomeen Appoints Project Director of Biological Chemistry
In this newly created position, Courtney will help grow Avomeen’s large-molecule and protein therapeutics business segment08.09.19
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Bio News | Breaking News | Cold Chain Management | Industry News | Packaging & Tracking
BioLife Solutions Aquires Savsu Technologies
Adds evo cold chain management system, designed for high-value, temperature-sensitive biologics, to its portfolio08.09.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
Genprex Partner Aldevron Completes Step in Mfg. for Oncoprex Clinical Devt. Program
Newly manufactured plasmids will be used in clinical trials evaluating Oncoprex in combination with targeted therapies and immunotherapies08.09.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Facilities | Industry News
Halix Completes New cGMP Facility
Company meets aggressive timelines for new biomanufacturing facility08.09.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
PTC Therapeutics Expands in New Jersey
Secures BMS biologics facility to support gene therapy production08.05.19
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Breaking News | Facilities | Industry News
Vetio Completes Plant Expansion in Montreal
Facility produces liquids, semi-solids, tablets, intermediates and blends08.02.19
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cGMP Manufacture | Collaborations & Alliances
NIIMBL, FDA to Advance Innovation in Bio Manufacturing
CRADA enables FDA and NIIMBL to support investments in regulatory science research, and training needed to foster advanced manufacturing innovations08.01.19
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Collaborations & Alliances | Logistics | Supply Chain
Lonza, Vineti Enter Cell and Gene Therapy Network Alliance
Integrated offering includes logistics, scheduling, distribution, Chain of Condition, Chain of Custody, Chain of Identity, and Lonza’s MODA-ES07.30.19
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Industry News | Process Development
Cambrex Expands Process Development at Edinburgh Facility
Doubles current footprint to 15,000 sq. ft., adding lab space to accommodate 40 more scientists07.30.19
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Bio News | Breaking News | Collaborations & Alliances | Industry News
AveXis, BIA Ink Gene Therapy Manufacturing Process Development Deal
BIA to provide expertise in next generation biomolecule purification processes and long-term supply of CIMmultus monolithic columns07.26.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Facilities | Industry News
GenScript Biotech Opens Biologics R&D and Production Center
Meets all U.S., EU and Chinese GMP requirements07.19.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
IDT Biologika Awarded New NIH Task Order
Part of 10-year NIH contract to manufacture vaccines and biologics for infectious diseases07.17.19
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cGMP Manufacture | Industry News | Scale-up/Technology Transfer
Mapi to Establish New Sterile Production Plant for GA Depot
Mapi will supply GA Depot to Mylan for commercial sale07.16.19
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cGMP Manufacture | Industry News
Catalent, AveXis Enter Long-term Strategic Mfg. Pact
AveXis will have dedicated manufacturing space at Paragon’s new commercial manufacturing center near Baltimore-Washington Int’l Airport07.16.19
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Breaking News | Industry News | Logistics | Packaging & Tracking
Marken Acquires Three European Logistics Companies
Expands logistics footprint in Italy, Austria and Hungary07.15.19
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Analytical Services | Laboratory Testing
Re-Open Your Tool Chest
There’s no longer an excuse NOT to start “PAT-ing” your productsEmil W. Ciurczak, DoraMaxx Consulting 07.15.19
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Breaking News | Excipients | Facilities | Industry News
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Biologics, Proteins, Vaccines | Industry News | Supply Chain
Werum IT Solutions Partners with Blood Centers of America
Strategic partnership to develop a “vein-to-vein” digital supply chain solution suite07.11.19
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Extractables and Leachables | Laboratory Testing
The FDA Gets Stricter with E&L Oversight, Can the Industry Keep Up?
Andrew Kolbert of Avomeen discusses FDA oversight of E&L testing, complications that arise, and the expertise needed to keep up with changing quality standardsKristin Brooks, Contract Pharma 07.11.19
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Passage Bio Announces New Gene Therapy Manufacturing Suite
Dedicated cGMP suite to be built under partnership agreement with Paragon Gene Therapy07.10.19
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Collaborations & Alliances | Drug Development
PTC Therapeutics, Odylia Therapeutics Enter Gene Therapy Alliance
Expands PTC's gene therapy portfolio to rare ophthalmic diseases07.02.19
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Bio News | cGMP Manufacture | Clinical Trial Materials | Drug Development | Industry News | Scale-up/Technology Transfer
Amicus, Catalent Biologics Enter Gene Therapy Mfg. Pact
Will support clinical and commercial supply needs for Pompe and other Lysosomal Disease Gene Therapy Programs07.02.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
Amicus, Brammer Bio Enter Gene Therapy Devt. and Mfg. Collaboration
Supports clinical and commercial supply needs for multiple batten disease programs07.01.19
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Industry News | Supply Chain
Cobra Biologics and Symbiosis Complete Viral Vector Supply Chain
Develops capabilities intended to accelerate the clinical and commercial production of viral vectors06.25.19
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Industry News | R&D
Sanofi Restructures R&D Group
To eliminate 466 jobs in France and Germany as part of a reorganization to focus on its immuno-oncology pipeline and gene therapies06.21.19
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Biologics, Proteins, Vaccines | cGMP Manufacture | Industry News
WuXi Biologics Plans to Further Expand New Bioconjugation Center
To include commercial manufacturing in Wuxi City, China06.21.19
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Bio News | Breaking News | Collaborations & Alliances | Industry News
Axovant, Yposkesi Sign Gene Therapy Deal
CDMO to support the global development and commercialization of Axovant’s gene therapy programs06.20.19
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Breaking News | Facilities | Industry News
Seqens Unveils Innovation and Development CoE
SEQENS'Lab is a development accelerator located just out of Paris06.20.19
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Analytical Services | Breaking News | Drug Development | Drug Discovery | Facilities | Industry News
Concept Life Sciences Opens New Facility
To offer complete pharmaceutical manufacturing support services06.20.19
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Promotions & Moves
Gemini Adds to Executive Leadership Team
Donald O’Neil to lead commercial efforts and Brendan Lucey to head up business development06.18.19
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Breaking News | Collaborations & Alliances | Industry News
Hoth Signs Contract Service Pacts for BioLexa
Particle Sciences, Regis Technologies called on for upcoming toxicology and clinical trials06.18.19
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Promotions & Moves
Avomeen Appoints Head of Elemental Analysis
Mr. Ferencz will help clients comply with regulations such as USP 232 and USP 233, as well as California Proposition 6506.17.19
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Biologics, Proteins, Vaccines | Clinical Trial Materials | Industry News
Catalent Biologics, IVERIC bio Ink Mfg. Pact
Paragon Gene Therapy, part of Catalent Biologics, will provide materials for preclinical and Phase 1/2 trials for IVERIC’s gene therapy product candidates06.17.19
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Collaborations & Alliances | Drug Development
Voyager Therapeutics, Sanofi Genzyme Restructure Gene Therapy Alliance
Voyager gains worldwide rights to VY-HTT01 Huntington’s disease program and ex-U.S. rights to VY-FXN01 Friedreich’s ataxia program for $10 million upfront06.17.19
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The 20th Annual Salary Survey
Plus: packaging trends, data integrity, serialization, ADCs and expediting clinical developmentTim Wright, Editor 06.13.19
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APIs
Catching Up With Cambrex
Contract Pharma talks with Shawn Cavanagh about the recent acquisitions of Halo and Avista.Tim Wright, Editor, Contract Pharma 06.13.19
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Trials & Filings
AveXis’ Zolgensma Aproved for Pediatric Patients with Spinal Muscular Atrophy
The first and only gene therapy approved by the FDA for the treatment of SMA, including those who are pre-symptomatic at diagnosis06.13.19
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The Orphan Promise
New policy on rare disease treatments likely soonS. Harachand, Contributing Editor 06.13.19
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Biologics, Proteins, Vaccines | Drug Development
The Future Is… Therapeutic
As cell and gene therapies rise, so too does outsourcingBen Locwin 06.13.19
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Breaking News | Industry News
Aptar Broadens Pharma Services Platform
Acquires Nanopharm and Gateway Analytical to accelerate customer drug development06.12.19
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Breaking News | Facilities | Industry News | Solid Dosage/Creams/Ointments
Tergus to Build Commercial Manufacturing Facility
Adds commercial capabilities and will expand current capacity by 400%06.12.19
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Biologics, Proteins, Vaccines
Advancing Cell and Gene Therapies
Amy DuRoss of Vineti discusses the key challenges cell and gene therapies face and advances to enhance safety, speed, and accessKristin Brooks, Contract Pharma 06.10.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
Abzena Bolsters Development Timeline Capabilities
Unveils 14-month cell line to phase 1 GMP service; appoints Shahram Katousian as head of biologics manufacturing06.10.19
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cGMP Manufacture | Clinical Trial Materials | Industry News
Phoenix Molecular, WuXi STA Reach Drug Supply Milestone
Completes clinical trial supply to support Phase I/Ib study of PMD-026 for TNBC06.07.19
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Drug Development | Industry News
Biogen Completes $800M Nightstar Acquisition
Gains two mid- to late-stage clinical assets and preclinical programs in ophthalmology06.07.19
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Breaking News | Industry News | Promotions & Moves
Symbiosis Boosts Business Development Team to Support US Growth
Helen Caddy-Leach to lead the Scottish CMO’s push into the U.S.06.06.19
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Bio News | Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News
apceth, bluebird bio Enter Mfg. Tie-up
apceth to operate as the commercial manufacturer in Europe for Zynteglo, bluebird bio’s gene therapy for β-thalassemia06.06.19
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Biologics, Proteins, Vaccines | Drug Development | Drug Discovery | Industry News
Servier Selects Yposkesi for CAR-T GMP-Mfg.
Yposkesi to develop and GMP manufacture lentiviral vectors to support allogenic CAR-T cell technology development06.05.19
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Bio News | Biologics, Proteins, Vaccines | cGMP Manufacture
Aldevron to Build 14-Acre Gene Therapy Mfg. Campus
Annual capacity will exceed $1 billion of plasmid DNA, RNA, gene editing enzymes, and other biologics06.03.19
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Bio News | cGMP Manufacture | Fill/Finish | Industry News
iBio Launches Sterile Fill-Finish Services
Initial capacity supports 100 – 2,500 vials runs, with plans to expand to 15,00006.03.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
Thermo Fisher, Scinogy Partner to Accelerate Cell and Gene Therapy Commercialization
New collaboration will enable scalable, cost-effective manufacturing processes05.31.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
Ampersand to Acquire Vibalogics
CDMO will expand capabilities to meet growing demand for development and manufacturing of complex viral products05.30.19
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Breaking News | Promotions & Moves
Almac Appoints Sheryl Foster VP of Quality
John Robson named vice president of analytical operations05.29.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Facilities | Industry News | Information Technology
Vineti Opens New Regional HQ in Maryland
New office expansion further enables accelerated cell and gene therapy clinical development and commercial operations in the Eastern United States05.28.19
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Drug Development
What I’m Looking Forward to at ASCO 2019
Erin Finot discusses the advances in science and oncology drug development at ASCOErin Finot, MS, MBA, Global Head of Immuno-Oncology, Oncology Division, IQVIA Biotech 05.28.19
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Bio News | Breaking News | Industry News
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Breaking News | GMPs/GCPs | Industry News
LSNE Receives GMP Certification by Brazil's ANVISA
Marks the first LSNE manufacturing facility to receive ANVISA certification05.14.19
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Breaking News | Industry News | Promotions & Moves
Paragon Strengthens Leadership Team
John Mosack head GMP mfg. at Baltimore site; Adam Sachs to lead program mgmt. and client alliance; Deborah Wild is chief quality and reg. affairs officer05.08.19
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Facilities | Solid Dosage/Creams/Ointments
ACG’s New $91M Brazil Facility
Touts major expansion of capsule manufacturing capabilities at CPhI05.08.19
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Information Technology
My Head is in The Cloud(s)
Cloud computing is making it easier to control all aspects of the global pharma production processEmil W. Ciurczak, DoraMaxx Consulting 05.07.19
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Biologics, Proteins, Vaccines
The Coming Revolution of Personalized Medicine
Cell and gene therapy is creating a momentous shift in the pharma landscape and reshaping the future of medicine.Tommy Fanning, Global Head Biopharmaceuticals, IDA Ireland 05.07.19
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Breaking News | Drug Discovery | Facilities | Industry News | R&D
Takeda Opens New Global Research Center in San Diego
New facility focuses on specialized drug discovery technologies and discovery research across gastrointestinal and neuroscience therapeutic areas05.06.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News | Scale-up/Technology Transfer
3P Bio, Intervacc Secure Large-Scale Mfg. Process
Tech transfer and scale-up of the mfg. process with verification of reproducibility for Strangvac production has been completed05.06.19
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Breaking News | Collaborations & Alliances | Drug Development | Industry News
Micro-Sphere Partners With PTM Consulting
Will offer customers support across the entire drug product development and manufacturing cycle05.06.19
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Industry News | Reader Showcase
Sartorius Launches New Cell Culture Microbioreactor System
New ambr 15 designed for improved clone selection as well as media and feed optimization in fed‑batch and perfusion mimic conditions05.06.19
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Promotions & Moves
Outlook Therapeutics Names Clinical SVP
Dr. Kissner brings extensive experience in therapeutic product development from the benchtop through clinical development and regulatory filing04.26.19
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Biologics, Proteins, Vaccines | cGMP Manufacture | Industry News
Precigen Opens Cell Therapy Mfg. Facility in MD
The 5,000 square foot facility in Germantown will manufacture early stage clinical trial material for gene therapy trials04.26.19
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Bio News | Breaking News | Facilities | Industry News
Chinese CDMO GenScript Breaks Ground
The GenScript-Legend Biotech Commercial Manufacturing Center to become China’s largest dedicated to cell and gene therapy research04.23.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Facilities | Industry News
Paragon to Build Second GMP Mfg. Facility
Expands collaboration in manufacturing design and operation with Sarepta Therapeutics04.17.19
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Bio News | Industry News
CEVEC Expands AAV Production Platform
Secures funding to expand commercialization of CAP GT-based stable adeno-associated viral (AAV) vector production platform04.16.19
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Clinical Trials | Drug Development | Information Technology
Vertex Takes a Risk-based Approach to UAT
Re-engineering processes with a modern EDC technology
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Analytical Services | Breaking News | Industry News
Almac Expands Global Analytical Services Capability
To bolster operations at its Athlone facility04.15.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
Catalent to Acquire Paragon for $1.2B
To provide new expertise and capabilities in fast-growing gene therapy space04.15.19
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cGMP Manufacture | Industry News
Paragon Opens New Biomanufacturing Facility in MD
New facility is equipped with several 500L and 2000L single-use bioreactors for clinical through commercial material production04.12.19
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Industry News
YMC Acquires ChromaCon Biz
Expands footprint in multi-column continuous purification technologies04.10.19
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Bio News | cGMP Manufacture | Collaborations & Alliances | Drug Development | Industry News | R&D
Merck & NJII Receive NIIMBL Award
To provide funding for the development of a training program to enable incumbent employees in the biopharma industry to acquire competencies in the field04.09.19
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cGMP Manufacture | Industry News
MilliporeSigma Launches BioContinuum Buffer Delivery Platform
Designed for more efficient buffer delivery and is tailored to provide the highest level of accuracy and precision in buffer preparation and management04.08.19
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Bioanalytical Services | Collaborations & Alliances
Thermo Fisher, Genovis Advance Bio-Characterization and Monitoring Methods
Aims to develop advanced end-to-end workflows for biotherapeutics analysis04.08.19
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Excipients
Pharmaceutical Excipients Trends
They’re not just unimportant background noise anymore.Emil W. Ciurczak, DoraMaxx Consulting 04.05.19
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Clinical Trial Materials
Clinical Trial Supply: The Pathway to Success
Early phase development and manufacture must be done quickly and efficiently to help keep costs low.Torkel Gren, Senior Director, Science & Technology Officer, Recipharm 04.05.19
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Solid Dosage/Creams/Ointments
Solid Dose Processing & Packaging Trends
Mikart’s senior vice president of business development, John M. Phillips, talks trends with Contract PharmaTim Wright, Editor, Contract Pharma 04.05.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
AveXis Buys Fourth US Plant
Novartis subsidiary expands gene therapy mfg. capacity with purchase of AstraZeneca site in Colorado04.05.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Facilities | Industry News
LakePharma Enhances Mfg. Operations
Launches GMP manufacturing of recombinant proteins and antibodies in the Bay Area04.05.19
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Bio News | Bioanalytical Services | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances
APC and NIBRT Enter Strategic Partnership
To enhance client access to their respective biopharmaceutical services04.03.19
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Bio News | cGMP Manufacture | Facilities | Industry News | Inspections
WuXi STA Mfg. Facility Passes GMP Inspection
New drug product manufacturing facility in Waigaoqiao Free Trade Zone of Shanghai has passed its first GMP inspection by the European Medical Products Agency03.27.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
Abzena Launches Developability and Optimization Service
Designed to improve lead selection and de-risk biologic cell line development03.25.19
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Breaking News | Drug Development | Industry News | Laboratory Testing
Thermo Fisher Acquires Brammer Bio in $1.7B Deal
The viral vector manufacturer for gene and cell therapies will join Thermo's Laboratory Products and Services segment03.25.19
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Breaking News | Promotions & Moves
Paragon Bioservices Appoints New CTSO
Bolsters leadership ranks to support late-stage clinical and commercial biopharma manufacturing03.22.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities
bluebird bio Opens Gene and Cell Therapy Mfg. Facility
NC's Gov. Cooper to cut ribbon on facility that will strengthen bluebird's capabilities to make products for clinical devt. and commercial supply03.22.19
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Bio News | Breaking News | cGMP Manufacture | Collaborations & Alliances | Preclinical Outsourcing | Process Development
WuXi STA Forms Partnership with Beta Pharma
STA will accelerate process R&D and manufacturing of late phase and commercial targets03.21.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances
Pall Enters Cell and Gene Therapy Mfg. Tie-up with NJII
Will invest $3.5 million in new innovation partnership03.19.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Collaborations & Alliances
MilliporeSigma, GenScript to Accelerate Cell and Gene Therapy Industrialization in China
Collaboration to build global-standard platform for plasmid and virus manufacturing in China03.19.19
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Breaking News | Industry News
Sheba, Lonza Collaborate on Cell Therapy Mfg. Platform
Will assess automated CAR-T cell therapy manufacturing at the point-of-care03.18.19
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Breaking News | Cold Chain Management | Packaging & Tracking
BioLife Solutions Acquires Astero Bio
Gains products that automate the thawing process for high-value biologic therapies03.14.19
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APIs | Breaking News | Industry News
Sterling Pharma Solutions Acquired by GHO Capital
Sterling provides API development and GMP manufacturing services03.14.19
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Bio News | Breaking News | cGMP Manufacture | Facilities
Goodwin Biotechnology Expands Capacity
Invests in doubling space available for cGMP capacity as it readies for further expansion of its biopharma manufacturing business03.08.19
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Nutraceutical Brands Find Relief in Outsourcing Manufacturing
More companies are working with contract manufacturers to manage resources and focus on business development.Sean Moloughney, Editor, Nutraceuticals World 03.06.19
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Information Technology
Industry 4.0 in the Pharma Industry
Digitization is not a single-handed project.Dr. Christian Hanisch, Project Manager Industry 4.0 Pharma, Bosch Packaging Technology 03.06.19
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2019 Trends & Predictions
Looking to the year ahead we discuss six key trends that will shape the industry.David Hukin and Thomas Underwood, QVigilance and Quanticate 03.06.19
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Fill/Finish | Injectables
Biopharma Contract Fill-and-Finish Market Trends
Biopharmaceuticals continue to fuel growth in the pharmaceutical industry.Cindy Liu and William Downey, HighTech Business Decisions 03.06.19
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Bio News | Breaking News | Clinical Trials | Drug Development | Industry News
Biogen to Buy Nightstar for $800M
Establishes clinical pipeline of gene therapy candidates in ophthalmology03.04.19
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Breaking News | Promotions & Moves
Avomeen Appoints QA Leader
Totton responsible for maintaining Avomeen’s compliance with regulatory requirements and standard operating procedures03.01.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
LakePharma Opens Vector Center in Mass.
New facility in Cambridge supports gene and cell therapy research, development and manufacturing02.28.19
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Bio News | Collaborations & Alliances | Drug Development | Industry News | Laboratory Testing
Sarepta to Acquire Myonexus for $165M
Will in turn acquire transformative gene therapies for five LGMDs: LGMD2E, LGMD2D, LGMD2B, LGMD2C and LGMD2L02.27.19
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Bio News | Facilities | Industry News
Amicus Announces Gene Therapy Center of Excellence
The new 75,000 sq.-ft. CoE in Philadelphia will be completed in 2H1902.26.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
Avexis to Invest $60M in New Mfg. Center
Gene therapy firm to make medicines for rare genetic diseases02.26.19
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Breaking News | Industry News
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Breaking News | Capsules | Facilities | Industry News | Solid Dosage/Creams/Ointments
ACG Capsules Expands in Brazil
ACG Capsules opens a new factory in Pouso Alegre-MG, the second in the region
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Bio News | Industry News | Promotions & Moves | Regulatory Affairs
Former FDA Senior Executives Join PAREXEL
The industry veterans will work on the company's Regulatory Consulting group02.15.19
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Bio News | Breaking News | Collaborations & Alliances | Drug Development | Industry News
3SBio, Verseau Establish Immuno-Oncology Devt. Collaboration
3SBio will fund and conduct antibody development and GMP manufacturing02.11.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
Enzene, Novasep Enter Continuous Mfg. Tie-up
Enzene chooses Novasep BioSC Pilot Chromatography for automated continuous manufacture of mAb02.05.19
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Breaking News | Promotions & Moves
EMD Serono Appoints Chief Compliance Officer
Jobes will oversee the strategic direction of EMD Serono's comprehensive compliance program02.04.19
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Biologics, Proteins, Vaccines
Next-Gen Translational Medicine
QPS triples the footprint of its Translational Medicine site in Delaware to support growth of gene therapies02.04.19
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Biologics, Proteins, Vaccines | Breaking News | Industry News
QPS Expands Translational Medicine Division
Triples footprint of its Translational Medicine site in Newark, DE02.04.19
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Industry News | Promotions & Moves
CavoGene Appoints CEO
Scott J. Fisher, PhD has previously led drug development and gene therapy clinical research of multiple regenerative therapies at early stage companies02.04.19
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Bio News | Collaborations & Alliances | Drug Development | Drug Discovery | Industry News | R&D
MeiraGTx & Janssen Enter Gene Therapy Collaboration
To develop and commercialize gene therapies for the treatment of inherited retinal diseases01.31.19
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Bio News | cGMP Manufacture | Collaborations & Alliances | Drug Development | Industry News
Hitachi Chemical Acquires apceth Biopharma
Hitachi nabs two state-of-the-art GMP/BSL2 production facilities including 600 square meters of cleanroom area01.31.19
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Bio News | Breaking News | Cold Chain Management | Facilities | Industry News | R&D | Supply Chain
Sharp Clinical Services Moves to New $23M Facility
Adds 1.5 million cubic feet of clinical services capacity on a 14-acre site; increases pallet space for cold and controlled-temperature storage by 50%
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Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News | Inspections
Upperton Pharma’s Nottingham Site Passes MHRA Inspection
Gains licenses for manufacture, downstream processing into capsules and tablets, as well as spray dried formulations of biotherapeutics and small molecule APIs01.16.19
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Breaking News | Promotions & Moves
Cobra Biologics Appoints Innovation Director
Sleep will work drive technical innovation to streamline process workflows and advance ATMP service offering01.15.19
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Breaking News | cGMP Manufacture | Industry News
FUJIFILM Diosynth Introduces Next-gen Apollo X
Designed to be a 'manufacturing-ready' cell line with a robust support package to aid IND filing01.11.19
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Bio News | Breaking News | Cold Chain Management | Industry News | Injectables
PCI Invests $20M in Biotech & Advanced Injectable Delivery Forms
Demand for biotech packaging drives significant PCI investment at multiple locations worldwide01.08.19
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Breaking News | Promotions & Moves
PTC Therapeutics Appoints CSO, CTO
Pykett to lead research initiatives, Almstead responsible for manufacturing and supply chain01.07.19
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Breaking News | cGMP Manufacture | Fill/Finish | Industry News
Catalent to Expand Biologics Capacity and Capabilities
To invest $200 million in its manufacturing sites in Madison, WI and Bloomington, IN01.07.19
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Breaking News | Facilities | Industry News
Almac Launches Second Line for High Throughput GMP Peptide
New facility will be based in Edinburgh01.04.19
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Breaking News | cGMP Manufacture | Industry News
Rentschler Biopharma Completes Acquisition of U.S. Mfg. Site
Rentschler will continue to manufacture for Shire at the 93,000 sq.-ft. site in Milford, MA01.03.19
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Bio News | Collaborations & Alliances | Drug Development | Drug Discovery | Industry News
Sarepta, Aldevron Enter Gene Therapy Agreement
Strategic relationship is for the supply of plasmid DNA to fulfill Sarepta’s needs for its gene therapy clinical trials and commercial supply01.02.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
Novartis Makes Offer for French CDMO
Proposed acquisition builds on existing agreement with CellforCure for contract manufacturing of Novartis' leading CAR-T cell therapy Kymriah12.26.18
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Bio News | Bioanalytical Services | Breaking News | Facilities | Industry News | Laboratory Testing
PPD Expands GMP Lab Testing Capabilities for Biologics
Enhances gene and cell therapy lab services across Europe and North America12.26.18
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Bio News | Bioanalytical Services | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
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Breaking News | cGMP Manufacture | Drug Development | Industry News
Rentschler Biopharma Buys U.S. Mfg. Site from Shire
Will leverage the development and manufacturing site for CDMO services12.17.18
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Bio News | Drug Development | Facilities | Industry News | Promotions & Moves | R&D
HemaCare Moves Into New HQ
Company has officially moved its global headquarters to Northridge, California, in a 40,000 sq. ft. building in the heart of the San Fernando Valley
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
Lonza to Establish Bio Mfg. Base in China
Will leverage GE Healthcare’s off-the-shelf biologics factory, KUBio, to provide the base for GMP manufacturing12.10.18
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Bio News | Biologics, Proteins, Vaccines | cGMP Manufacture | Facilities | Industry News | Laboratory Testing
PPD Expands GMP Lab Testing Capabilities
Adding 6,000 sq. ft. of gene and cell therapy analytical testing to Athlone, Ireland facility
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Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News | Scale-up/Technology Transfer
Voyager Therapeutics, Brammer Bio, Fujifilm Diosynth Enter Mfg. Tie-up
Collaborations to provide Voyager the ability and flexibility to transfer its mfg. capabilities across multiple vendors12.03.18
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
ABL Expands GMP Viral Vector Mfg. Capacity
Acquires state-of-the-art facility in Lyon, France12.03.18
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Bio News | Biologics, Proteins, Vaccines | Drug Development | Facilities | Industry News | R&D
GE Launches Biotechnology Mfg. Center
To produce a purification platform for efficiency in purification of mfg. biopharmaceuticals, gene therapies & viral vectors
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cGMP Manufacture | Fill/Finish | Parenterals | Solid Dosage/Creams/Ointments
Glenmark Establishes U.S. Ops
Robert Matsuk, president of North America at Glenmark discusses the significance of the new NC siteKristin Brooks, Contract Pharma 11.28.18
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Collaborations & Alliances
Cobra Biologics, Pall, Cell and Gene Therapy in Continuous Mfg. Tie-up
Aims to innovate in-process analytical techniques and manufacturing approaches based on continuous chromatography platforms11.26.18
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Aseptic Processing | Breaking News | cGMP Manufacture | Facilities | Fill/Finish | Industry News
Rentschler Inaugurates New Fill and Finish Facility
New high-tech facility to be used for the aseptic filling and freeze-drying of drug products11.20.18
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Analytical Services | Laboratory Testing
The Great Diaspora of the Pharma Industry
Or, good things come in small(er) packagesEmil W. Ciurczak, DoraMaxx Consulting 11.14.18
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Injectables | Parenterals
Market on the Rise: Parenterals
A look at trends and challenges in today’s parenteral manufacturing and development market.Emilie Branch, Strategic Content Manager, Nice Insight 11.13.18
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Analytical Services | Breaking News | Drug Development | Drug Discovery | Industry News
Concept Life Sciences Expands GLP Capabilities
MHRA confirms GLP extension at Dundee and Bradford sites11.08.18
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Bio News | Facilities | Industry News
ILC Dover Expands Ireland Footprint
New Blarney, County Cork, Ireland location will create up to 70 jobs over two years11.02.18
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Bio News | Breaking News | Industry News
Tropichem Becomes Vetio
The new name has been chosen to better reflect the Company’s exclusive focus as a CDMO for Animal Health11.02.18
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Bio News | cGMP Manufacture | Facilities | Industry News | Process Development
Glenmark Opens First U.S. Mfg. Site
100,000 sq.-ft. North Carolina facility is designed to manufacture a variety of fixed dose pharma formulations10.31.18
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Bio News | Drug Development | Drug Discovery | Facilities | Industry News
Thermo Fisher Officially Opens New Facility
The new business center and biorepository is located on the company's recently expanded campus in Frederick, Maryland10.31.18
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Bio News | Collaborations & Alliances | Drug Development | Drug Discovery | Industry News
Cobra Biologics, University of Leeds Receive Grant
£100K is to look into the effects of hydrodynamic force on the structure & biological integrity of viral vector gene therapy10.30.18
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Breaking News | Industry News
Velesco Acquires New cGMP Analytical Lab
Expands formulation and analytical research and development capabilities10.23.18
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Laboratory Testing | Methods Development
Advanced Analytical Features Services
Michelle Gonzalez, Client Services Specialist, spoke exclusively with Contract Pharma at Contracting & Outsourcing 2018
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
Paragon Enters Mfg. Partnership with Sarepta
Deal expands commercial capacity for Sarepta’s micro-dystrophin gene therapy program10.18.18
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Bio News | Collaborations & Alliances | Drug Development | Drug Discovery | Industry News | R&D
MeiraGTx, Janssen Enter Research Collaboration
MeiraGTx will use their riboswitch technology to engineer gene therapy constructs encoding gene sequences from Janssen10.18.18
- Breaking News