RESOURCES

THE EVOLUTION OF CELL AND GENE THERAPY PROCESSING TOOLS

Automation is Needed - for scale & safety

The unprecedented growth of the industry, alongside the need to develop scalable manufacturing strategies, has led to a number of challenges that need to be addressed urgently. Previously, patient numbers were so small that processes were highly manual and required numerous skilled operators. However, the recent success of early gene therapy trials means upscaling now needs to be considered right from the start. Safe and scalable gene therapies require access to manufacturing capacity that employs state-of-the-art technologies for efficient, robust and scalable production, which creates a series of questions and considerations that must be considered earlier, rather than later, in the therapy development process.

  • Identifying when to implement automation
    • History of automation within CGT
      • Define historical automation strategies
      • Early attempts at automation
    • Challenges
      • The importance of early-stage automation
      • Cost of therapy development
      • Safety
    • Key decision factors driving the answer to “when”
    • Introducing new products
      • AF-500
      • Non-Sexton automation products
      • Challenges of these large scale automation products
    • The solution – produce a small footprint, low cost, highly flexible automation platform
      • CT-5
        • Specific importance of the product
        • Aa a lynchpin of bridging industry solutions
      • Any other non-Sexton products like this????
    • Future direction
      • Lowering the barrier to entry – barrier to entry is typically cost and lock you into a certain consumable… so future is building devices like CT-5, our vials, etc., that work both within our product universe as well as plug and play in someone else’s product universe.