Cell Culture Technology– category –
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FDA Finalizes Guidance on CMC Flexibility for Cell and Gene Therapies, Expediting Access to Advanced Treatments
Regulatory Focus USA Overview The U.S. FDA has issued final guidance outlining flexible Chemistry, Manufacturing, and Controls (CMC) requirements for cell and gene therapy (CGT) products, recognizing their inherent complexities compared ... -
Thermo Fisher Bolsters Cell Therapy Manufacturing with New Single-Use Bioreactor and Integrated Bioprocess Hub
Simply Wall St USA Overview Thermo Fisher Scientific has launched the Gibco CTS DynaXS Single Use Bioreactor, engineered for scalable and precise cell therapy manufacturing, alongside a new U.S. Bioprocess Design Center. This strategic e...
