Cell & Gene Therapy
Formed in 2018, Cell & Gene Therapy (CGT) supports the quest for better and faster development of cell and gene therapies. In this collaboration, we connect drug development and contract manufacturing organizations with the aim of ensuring harmonization and alignment around issues such as potency assays, phase-appropriate guidance for critical quality attributes, operator safety, regulatory guidelines, and C>-specific validation issues, as well as working towards resolving the current challenges to commercializing C> products.
The business of cell and gene therapy is as diverse as the patients which it serves and for that there is no one size fits all solution.
Cell & Gene Therapy case study
Plasmids release specifications
Aligning industry in a bid to reduce costs, timelines, and testing….
Leveraging the CGT process maps
Current technology for cell and gene therapies (CGTs) is unsuitable for large-scale production This is partly because there is no common standard for the industrial manufacturing of CGTs….
CGT environmental health and safety
The rapidly expanding field of cell and gene therapies (CGT) could revolutionize curative treatments. Regulatory guidance has been developed to address manufacturing guidelines and CMC specifications for CGT drug products….