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FDA Announces Flexible Manufacturing Approach for Cell and Gene Therapies on January 11, 2026

2 weeks ago talkbio0Tagged calcium glucarate, Candidiasis, Chronic Mucocutaneous, Cells, gene therapy, Manufacturing, Pliability, requirements, United States Food and Drug Administration

FDA; cell and gene therapies; CGT; manufacturing flexibility; CMC requirements; Marty Makary

Strategic Roadmap for Biologics Manufacturing: Enhancing Efficiency and Flexibility

1 year ago talkbio0Tagged Biological Factors, biomanufacturing, bony process, Characterization, Continuous, Efficiency, Manufacturing, Modular Facilities, Pliability, Precision medicines, Regulatory Compliance, Strategic Roadmap, technology roadmap

Biologics manufacturing, Strategic roadmap, Process characterization, Flexibility and efficiency, Regulatory compliance, Biomanufacturing technology roadmap, Precision medicines, Modular facilities, Continuous manufacturing