Chemistry, Manufacturing, and Controls– tag –
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Celularity and MuseCell Innovations® Forge US Manufacturing Partnership, Projecting Over $300M in Purchases for Dezawa MuseCell® Platform
Celularity (Press Release) USA Overview Celularity Inc. announced a US manufacturing collaboration with MuseCell Innovations®, with Celularity's Florham Park, NJ facility set to produce Dezawa MuseCells® and related products. This partne... -
FDA Expands Regulatory Flexibility for Cell and Gene Therapies, Streamlining CMC Requirements to Accelerate Early Clinical Development
Medicinova, Inc. (Facebook) USA Overview The US FDA has announced an expansion of regulatory flexibility for Cell and Gene Therapy (CGT) products, particularly adapting Chemistry, Manufacturing, and Controls (CMC) requirements across the... -
FDA Finalizes Q&A Guidance on Cell and Gene Therapy Product Development, Clarifying Regulatory Review, CMC, and Safety Monitoring
RAPS (Regulatory Affairs Professionals Society) USA Overview The U.S. FDA has released final FAQ guidance on developing cell and gene therapy (CGT) products, providing practical answers to common regulatory questions spanning regulatory ... -
Hopstem Biotech Closes ~RMB 200M Series C Funding to Accelerate Development of FDA RMAT-Designated iPSC Cell Therapy hNPC01
Insight, China's Pharmaceutical Industry China Overview Hopstem Biotechnology announced the first close of its Series C funding round, raising approximately RMB 200 million (~$40 million USD). This capital will accelerate clinical develo... -
FDA Finalizes Flexible CMC Framework, Ending ‘Rule of Three’ for Cell and Gene Therapy Approvals
BioProcess International USA Overview The FDA has issued a finalized "Level 2" guidance document for Chemistry, Manufacturing, and Controls (CMC) flexibilities in cellular and gene therapy (CGT) products, effectively concluding the "Rule... -
FDA Finalizes Flexible CMC Framework for Cell and Gene Therapy Approvals, Accelerating Personalized Medicine Regulatory Pathways
BioProcess International USA Overview The U.S. FDA finalized a flexible Chemistry, Manufacturing, and Controls (CMC) framework for cell and gene therapy (CGT) product approvals, releasing a guidance document on May 5, 2026. This framewor... -
FDA Introduces Flexible CMC Guidance for Cell and Gene Therapy Products, Ending ‘Rule of Three’ for Commercial Validation Batches
BioProcess International USA Overview The FDA published and immediately implemented Level 2 guidance, 'CMC Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application' on May 5, 2026. This la... -
FDA Flexibilizes Cell and Gene Therapy CMC Regulations, Eliminating ‘Rule of Three’ to Accelerate Development
BioProcess International USA Overview The U.S. FDA has announced a flexible Chemistry, Manufacturing, and Controls (CMC) guidance for Cell and Gene Therapy (CGT) products, effectively ending the traditional 'Rule of Three' validation req... -
ProBio’s AAV Manufacturing Excellence Accelerates UC Irvine and GlyTR Therapeutics’ Pan-Cancer CAR-T Program, Achieving 80% CAR Gene Insertion Efficiency
University of California, Irvine USA Overview ProBio's advanced AAV manufacturing technology is critically powering pre-IND research for the first-in-class pan-cancer CAR-T program developed by UC Irvine and GlyTR Therapeutics. ProBio's ... -
Porton Advanced Fortifies End-to-End ATMP CDMO Services with Over 250 Global Clients
Porton Advanced China Overview Porton Advanced is strengthening its end-to-end CDMO solutions for Advanced Therapy Medicinal Products (ATMPs), serving over 250 global customers. The company offers cell engineering CMC services for autolo...
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