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The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.

Oklahoma Facility Given FDA Warning

The Russian Direct Investment Fund has announced three deals with India, Brazil, and Mexico, for the supply of doses of Sputnik V, a potential COVID-19 vaccine.

Russia Completes Deals with India, Mexico, and Brazil for Sputnik V

The companies aim to scale up production of Eli Lilly’s potential COVID-19 antibody therapies, pending regulatory approval.

Eli Lilly and Amgen Partner for COVID-19 Therapy Manufacturing Capacity

BioNTech plans to produce up to 250 million doses of its COVID-19 vaccine candidate, BNT162b2, in the first half of 2021.

BioNTech to Acquire Novartis GMP Facility for COVID-19 Vaccine Production

The new facility will produce cell therapies for clinical evaluation from discovery through to Phase 2b trials while expanding Takeda’s abilities to develop next-generation cell therapies.

Takeda Opens New R&D Cell Therapy Manufacturing Facility

The new particle counter allows users to import their standard operating procedure routine environmental monitoring maps and sampling configurations into the counter, which reduces human error and can improve data integrity.

Beckman Coulter Life Sciences Launches the MET ONE 3400+ Portable Air Particle Counter for Cleanroom Compliance

Valneva will supply the UK government with an initial 60 million doses of the vaccine in the second half of 2021, if successful, and will provide more doses thereafter. 

Valneva Enters into $1.6-Billion Partnership with UK Government for COVID-19 Vaccine

The APS system comes equipped with filter switching, liquid management, and cell bleed to reduce risk of human error and increase process robustness.

Cytiva Introduces the Xcellerex Automated Perfusion System

The funding will help advance the vaccine’s clinical evaluation, potential marketing authorization, development and manufacturing in Germany, and the number of participants in late-stage clinical trials.

BioNTech to Receive Funding from BMBF for its COVID-19 Vaccine Program

GenSight Biologics has submitted a marketing authorization application to the European Medicines Agency for Lumevoq.

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