Alternatives to traditional freeze-drying may reshape biological development and the cold chain.

Beyond Lyophilization

A clinical-stage company produces adeno-associated virus vectors in-house.

Finding Success in AAV Manufacturing

Manufacturing increases but future demand remains unpredictable.

Meeting Demand for Vials and Syringes

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Articles

Vertex and CRISPR have amended their collaboration agreement to include the development, manufacture, and commercialization of CTX001, an investigational CRISPR/Cas9-based gene editing therapy for sickle cell disease and transfusion-dependent beta-thalassemia.

Vertex Pharmaceuticals and CRISPR Therapeutics Amend Agreement for $1.1 Billion

Post-inspection report reveals nine sanitary and process problems at Bayview, Md., facility.

Emergent BioSolutions Hit with FDA Form 483 

CalAmp's new sensor for cold-chain applications provides visibility for shipping vaccines.

CalAmp Launches End-To-End Supply Chain Visibility Solution for Cold Chain

Pending a completed FDA inspection, Emergent BioSolutions halts manufacture of vaccine drug substance at Maryland facility. 

Emergent BioSolutions Pauses Vaccine Manufacturing 

CordenPharma’s expansion will include the addition of new production lines which will be merged into the lipid manufacturing process in April 2021.

CordenPharma to Expand Lipid Purification Capacity at its Colorado Site

Sartorius has expanded in the United Kingdom with the relocation to a new facility in Havant, Hampshire, for downstream processing equipment.

Sartorius Opens New Downstream Center of Excellence Facility in UK

The new Abzena facility will initially include four modular suites with up to two 2000-L bioreactors, followed by the addition of two more 2000 L suites.

Abzena Names North Carolina Location for New GMP Manufacturing Facility

The ATMPS and Ori Biotech collaboration aims to improve visibility and reporting of cell and gene therapy manufacturing through a pre-integrated data solution.

ATMPS and Ori Biotech Collaborate on Integrated Digital Platform for Cell and Gene Therapy

Catalent’s new mammalian cell culture suites in Madison, Wis. use single-use bioreactor systems for CGMP clinical and commercial manufacturing.

Catalent Completes Expansion of its Biologics Drug Substance Facility in Wisconsin  

The China National Medical Products Administration has given the company the green light to begin manufacturing commercial supply of its approved anti-PD-1 antibody, tislelizumab, at its biologics facility in Guangzhou, China.

China Approves BeiGene for Commercial Manufacturing at its Biologics Facility

Cleanroom Equipment and Supplies

Clinical Trial Materials