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Contract Service Directory
Coriolis Pharma
Company Headquarters
18B Fraunhoferstraße
Planegg, BY 82152
Germany
Contract Service Directory
- Accelerated Stability Studies
- Agglomeration
- Analytical Laboratory Services
- Analytical Methods Development
- Analytical Validation Studies
- Bioanalytical Analysis LC/MS/MS
- Bioanalytical Services
- Biological Testing
- Biosimilars
- Chemical Analysis
- Chromatographic Analysis, LC/GC
- Chromatography
- Container Testing
- Contract Research
- Dosage Form Development
- Excipients
- Feasibility Studies
- Forced Degradation Studies
- Formulation Development
- Gene Therapy & Testing Protocols
- High Throughput Screening
- HPLC
- In Vitro Testing
- Lot Release Testing
- Lyophilization
- Mass Spectrometry
- Methods Development
- Methods Validation
- Micro FT-IR Analysis
- Nonclinical Research
- Parenterals Development
- Parenterals, Ampule Filling
- Parenterals, Syringe Filling
- Parenterals, Vial Filling
- Particle Characterization
- Particle Size Analysis
- Particle Size Classification
- Photostability
- Physical Testing
- Pilot-Scale Filling
- Polymerase Chain Reaction
- Preclinical Study Design
- Preclinical Testing
- Preclinical Testing Formulations
- Preformulation
- Process Analytical Technology (PAT)
- Process Characterization
- Process Development/Scale-Up Services
- Process R&D
- Process Validation Studies
- Project Management
- Protein Extraction/Purification
- Purification
- QA/QC
- Quality Control Testing
- R&D Services
- Stability Studies
- Stability, ICH
- Syringe Filling
- UV-VIS Spectrophotometer Analysis
- X-Ray Powder Diffraction
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Breaking News | cGMP Manufacture
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VectorBuilder, Univercells Form Viral Vector Production Pact
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
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Biologics, Proteins, Vaccines | Breaking News | Drug Development | Trials & Filings
AskBio’s Gene Therapy Program Gets Fast Track Designation
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APIs | Breaking News | cGMP Manufacture | Cytotoxics and High Potency Manufacturing | Industry News
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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 | Biologics, Proteins, Vaccines | Extractables and Leachables
On-Demand Lab Open House
Sign up to get a close-up look at our US network of laboratories and hear about our expansion plans.
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
Genezen Breaks Ground on cGMP Lentiviral Vector Production Facility
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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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Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
Frontera Therapeutics Starts GMP Manufacturing Facility Construction
Designed for clinical manufacturing and initial commercial manufacturing of rAAV gene therapy products.06.23.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Drug Discovery | Facilities | Industry News
AbCellera to Build Antibody Manufacturing Facility in Canada
130,000-square-foot Vancouver facility aims to accelerate the development of antibody-based therapies for an array of medical conditions.06.23.21
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Breaking News | Clinical Trial Materials | Industry News
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Breaking News | Facilities | Formulation Development | Industry News
Coriolis Pharma Expands ATMP Development Facilities
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Breaking News | Industry News | Laboratory Testing
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
Yposkesi to Build Second Commercial Bioproduction Site
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Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Facilities | Industry News
Vibalogics Expands Manufacturing Capacity
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
ProCell for Patient Project to Develop Automated Production Unit for CAR-T Cell Therapies
Standardized and automated manufacturing aims to reduce the amount of work on producing CAR-T cells by 50 percent.06.10.21
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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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Bio News | Breaking News | cGMP Manufacture | Facilities | Industry News
Fusion to Build Radiopharma Manufacturing Facility
New 27,000 square foot site will be operational by 2024.Tim Wright, Editor, Contract Pharma 06.07.21
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
VIVEbiotech Launches Lentiviral Vectors Mfg. Plant
Increases production capacity by 400% to deliver commercial-size batches for Cell and Gene Therapy Sector.Kristin Brooks 06.04.21
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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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Promotions & Moves
Selexis SA Appoints Hoffmann-Hecht CBO
Dr. Hoffmann-Hecht will serve on the executive leadership team and will report to Selexis CEO Dirk Lange.Kristin Brooks 06.02.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
CCRM Enters Regenerative Medicine Partnerships
Signs agreements with Canadian and international institutions to advance regenerative medicine inventions.Tim Wright, Editor, Contract Pharma 06.01.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
Thibault Jonckheere Named CEO of Exothera
The viral vector CDMO spinoff of Univercells is making an intranasal vaccine candidate for Covid-19 treatment.Tim Wright, Editor, Contract Pharma 06.01.21
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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 | cGMP Manufacture | Collaborations & Alliances
Ori Biotech and Vineti Enter Non-Exclusive Partnership
Will produce a fully pre-integrated solution to modernize, fast-track, and streamline the manufacture and delivery of cell and gene therapies.Charles Sternberg, Assistant Editor 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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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Drug Development | Industry News
Gamma Biosciences Acquires Stake in Mirus Bio
Supports Mirus’ expansion of GMP production of its flagship product TransIT VirusGEN for large scale manufacturing of AAV and LV viral vectors for gene therapy.Kristin Brooks 05.18.21
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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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Biologics, Proteins, Vaccines | Breaking News | CRO News | Industry News
Charles River to Acquire Vigene Biosciences
Expands Charles River’s scientific capabilities in the high-growth cell and gene therapy CDMO sector.Charles Sternberg, Assistant Editor 05.17.21
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Breaking News | Industry News | Promotions & Moves
Matica Biotech Names Dr. Yun Jeong Song as CEO
Song's background spans more than 20 years of basic research, patient care and biopharmaceutical industry leadership.Charles Sternberg, Assistant Editor 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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Analytical Services | Breaking News | Facilities | Industry News | Laboratory Testing
Cambrex Expands Analytical Services Capabilities
Adds 1,800 square feet of lab space at Longmont, CO facility.Tim Wright, Editor, Contract Pharma 05.11.21
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Bio News | Breaking News | Collaborations & Alliances | Drug Development | Industry News
3P and Buzzard Pharmaceuticals Enter Cancer Collaboration
Enter into a partnership agreement for manufacturing of the potent IL-1 inhibitor Isunakinra.Charles Sternberg, Assistant Editor 05.07.21
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
Catalent Acquires Commercial-Scale Plasmid DNA Mfg. Facility
Promethera’s Hepatic Cell Therapy Support SA include's 32,400 sq.-ft. facility in Gosselies, Belgium.Kristin Brooks, Contract Pharma 05.06.21
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Clinical Trials | Logistics | Supply Chain
LabConnect, Cryoport Partner to Support Triumvira Trial Logistics
Will integrate Cryoport's Cryoportal Logistics Management Platform and LabConnect's SampleGISTICS platform to provide Triumvira with advanced logistics support.Kristin Brooks, Contract Pharma 05.06.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News | R&D
Albumedix Extends Research Collaboration with Cobra Biologics
Collaboration investigates enhanced manufacturing of AAV and lentiviral vectors to improve quality and productivity for gene therapy and vaccine developers.Tim Wright, Editor, Contract Pharma 05.03.21
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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 | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development | Industry News
CCRM and Amgen Partner to Advance Emerging Medical Innovations
New fund to support regenerative medicine discoveries with high potential impact for patients.Tim Wright, Editor, Contract Pharma 05.03.21
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Breaking News | cGMP Manufacture | Collaborations & Alliances | Drug Development
AavantiBio, Catalent Enter Gene Therapy Alliance
Aims to advance AavantiBio’s gene therapy pipeline, including its lead program in Friedreich’s Ataxia (FA)Kristin Brooks 04.28.21
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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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Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
RDIF, Minapharm to Make Over 40M Doses of the Sputnik V Vaccine in Egypt
Production will take place in Minapharm’s biotech facility in Cairo for global distribution.Tim Wright, Editor, Contract Pharma 04.23.21
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Biologics, Proteins, Vaccines | Breaking News | Industry News | Information Technology
ATMPS, Ori Biotech Integrate Digital Platform for Cell & Gene Therapies
Aims to provide improved product tracking, scheduling and live monitoring of the manufacturing status across the entire CGT supply chain from vein to vein.Kristin Brooks 04.14.21
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
Albumedix Completes Commercial-Scale Mfg. Facility Expansion
Will service increasing demand for products and technologies for cell and gene therapies, vaccines, diagnostics, protein and peptide therapeutics.Kristin Brooks 04.14.21
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APIs | Drug Development | Process Validation
Exploring ICP-MS expertise at Almac
A discussion about Inductively Coupled Plasma Mass Spectrometry (ICP-MS) and its importance within drug development.
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
Catalent Biologics Completes Madison Expansion
More than doubles overall CGMP-scale capacity increasing the number of manufacturing suites at the site to five.Kristin Brooks 04.13.21
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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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Breaking News | Industry News | Promotions & Moves
Rentschler Biopharma Names Martin Kessler as New CEO in U.S.
Will drive company-wide transformation and lead the ongoing expansion at the U.S. site.Tim Wright, Editor, Contract Pharma 03.31.21
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Breaking News | cGMP Manufacture | Industry News
EMA Approves BioNTech's COVID Vax Production at Marburg Site
Largest mRNA vaccine manufacturing site in Europe has annual production capacity of up to one billion doses of its COVID-19 vaccine.Kristin Brooks 03.26.21
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Collaborations & Alliances | Drug Development | Industry News
CyanVac and Exothera Enter COVID-19 Vaccine Partnership
CDMO Exothera selected for the development and GMP manufacturing of intranasal vaccine candidate for Phase III clinical trial is Europe and the U.S.Tim Wright, Editor, Contract Pharma 03.25.21
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Breaking News | Formulation Development | Industry News
Rentschler, Leukocare Extend Service Offering with U.S. Site
Opens Leukocare’s U.S. development labs and offices at Rentschler's facility in the Greater Boston area, where the two companies will work together.Kristin Brooks 03.22.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Facilities | Industry News | Parenterals
Genopis Renamed Wacker Biotech US
Plasmid DNA contract manufacturer was recently acquired by Wacker.Tim Wright, Editor, Contract Pharma 03.19.21
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Bio News | Breaking News | Collaborations & Alliances | Industry News
Fujifilm and Sana Biotechnology Enter Cell Therapy Partnership
Enter license agreement for the development of iPSC-derived cell therapies.Tim Wright, Editor, Contract Pharma 03.17.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Facilities | Industry News | Parenterals
WuXi Biologics to Acquire Manufacturing Facilities from Pfizer China
Immediately boosts commercial Drug Substance and Drug Product capacities for WuXi Biologics to address surging manufacturing demands.Tim Wright, Editor, Contract Pharma 03.17.21
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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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Bioanalytical Services | Breaking News | Industry News | Preclinical Outsourcing
Altasciences Contributes to Vibegron Approval
Provided clinical support for two drug-drug interaction studies and a bioavailability trial for the overactive bladder treatment.Kristin Brooks 02.24.21
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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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Bio News | Breaking News | Collaborations & Alliances | Industry News
Bone Therapeutics, Rigenerand Ink Cell Therapy Deal
Enter an agreement for a process development partnership.Contract Pharma Staff 01.19.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
Cognate BioServices Announces Major Expansion
Will increase cell and gene therapy manufacturing capacity, laboratory space, warehousing capabilities and more.Contract Pharma Staff 01.15.21
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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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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
Precision Medicine Group Acquires Project Farma
Adds Project Farma's unique expertise to Precision's suite of end-to-end cell and gene therapy capabilities to support development and commercialization.Contract Pharma Staff 01.14.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
RheinCell Therapeutics Achieves GMP Certification
Marks a milestone for the evolution of the company.Contract Pharma Staff 01.13.21
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Oligonucleotides
Syngene's services encompass Therapeutic oligonucleotides, Diagnostic Oligonucleotides, Enzymatic synthesis and analytical services.
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Facilities | Industry News
Genezen Laboratories Receives Growth Equity Investment
Will fund the completion of the company’s lentiviral vector production facility.Contract Pharma Staff 01.05.21
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Breaking News | cGMP Manufacture | Industry News
Passage Bio, Catalent Begin cGMP Mfg. for Gene Therapies
Completion of dedicated cGMP suite enhances manufacturing readiness and secures supply chain control to support lead CNS product candidates.Contract Pharma Staff 12.10.20
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Breaking News | Drug Development
ViGeneron and WuXi Advanced Therapies Enter Partnership
Will accelerate production for the clinical development of VG901, a next-generation ophthalmic gene therapy program.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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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development | Industry News
CureVac and Wacker Sign Contract for Manufacturing of Covid-19 Vaccine Candidate
Manufacturing at Wacker’s biotech site in Amsterdam is scheduled to start in the first half of 2021.Contract Pharma Staff 11.24.20
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Pre-filled Syringes & Injectable Drug Trends
Pre-filled syringes have become a preferred format, as they make it easier to handle drugs and increase dos- ing accuracy.11.23.20
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Promotions & Moves
Catalent Appoints Open Innovation, Biologics, Cell and Gene Therapy VP
Behzad Mahdavi brings more than 20 years of experience in developing and implementing growth strategies in the biopharmaceutical industries.Contract Pharma Staff 11.19.20
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
Asahi Kasei Pharma Contracts ProBioGen
Will use ProBioGen’s technologies for the advancement of its biologics pipeline.Contract Pharma Staff 11.18.20
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Bio News | Breaking News | Industry News
Bionova Scientific Secures First Client Commitment
Its new biologics manufacturing facility is still months from completion.Contract Pharma Staff 11.18.20
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
CEVEC, Roche Ink ELEVECTA Technology License Agreement
Allows Roche to use CEVEC's ELEVECT Technology for AAV vector manufacturing for its portfolio of gene therapy products.Contract Pharma Staff 11.11.20
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
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
Covers the development and manufacturing of AAV vectors, a key step for Sensorion’s gene therapy programs.Contract Pharma Staff 11.03.20
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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
Zolgensma, which leverages REGENXBIO's NAV AAV9 vector, reaches $1 billion in sales.Contract Pharma Staff 10.27.20
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
CEVEC, Rznomics Ink License Agreement for CAP Technology
Rznomics will use CEVEC’s cell line technology with its trans-splicing ribozyme technology for manufacturing gene therapies targeting various cancers.10.20.20
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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
Will accelerate the commercialization of Koligo’s KYSLECEL, a personalized islet cell therapy available in the U.S. for chronic and recurrent acute pancreatitisContract Pharma Staff 09.29.20
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Bio News | Breaking News | Facilities | Industry News
Arranta Bio Establishes Commercial-Ready Manufacturing Facility
Enables the CDMO to supply vital products to patients in need.Contract Pharma Staff 09.28.20
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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
Supports the development and commercialization of Axovant’s AAV gene therapy programs.Contract Pharma Staff 09.16.20
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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
Bottling and labeling of clinical trial batches are expected to begin in early October led by Eurofins CDMO.Contract Pharma Staff 09.08.20
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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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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
Cobra Produces Master Cell Banks for CombiGene’s Gene Therapy
A milestone in the manufacture of a drug candidate for the treatment of focal epilepsy.Contract Pharma Staff 08.18.20
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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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A Guide to Vaccine Development from Lubrizol Life Science
The current COVID-19 pandemic emphasizes the need for safe and effective vaccines against new pathogens.
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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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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