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  6.  » Accelerating Your Gene Therapy to Patients: Not All Platforms Are Created Equal

Accelerating Your Gene Therapy to Patients: Not All Platforms Are Created Equal

Summary: The field of gene therapy manufacturing faces a significant hurdle in the form of a lack of process standardization. However, there are ways to address this challenge, such as using standardized methods, materials, analytics, and documentation. By implementing these measures, it is possible to minimize supply chain bottlenecks and increase manufacturing efficiencies and scalability. This, in turn, can lead to faster development timelines and smoother regulatory filings. In this fireside chat, George Buchman, Ph.D., Vice President, Pre-Clinical and Process Development, Catalent Cell & Gene Therapy and Thomas VanCott, Ph.D., Chief Scientific Officer, Combined Therapeutics, explore how a complete platform approach to fast-track AAVs can enhance quality and efficiency. This method can also help reduce manufacturing time while providing a well-suited process for late-stage clinical GMP production.

Key Learnings:

  • How standardized processes impact the timeline, development and manufacturing efficiency of AAV vector to the clinic
  • How clonal HEK-293 suspension-based processes improve the scalability and yield of AAV vector production
  • The advantages off-the-shelf plasmids offer compared to commercial plasmid vectors in terms of yield and packaging efficiency when used with a platform clonal cell line

Click here to view the webinar