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Gene Therapy Manufacturing 2.0

Over the past century, therapeutics developed from plant extracts to chemically defined small molecules and then on to large molecule based recombinant proteins. After decades of relentless scientific efforts, gene and cell therapy, whose promise was envisioned for decades, now fuel the next step change of the therapeutic landscape, opening entirely new routes towards previously unaddressable disease states.

Our whitepaper reviews:

  • The production of early gene therapy clinical and commercial batches as Gene Therapy Manufacturing 1.0 (GTM 1.0)
  • a significant supply chain gap in which viral vector demand exceeds the current supply-and that gap is increasing
  • technical developments that increase productivity and efficiency are immediately required to meet current demands and then fuel future endeavors

This review summarizes a select number of GTM 1.0 challenges and outlines potential Gene Therapy Manufacturing 2.0 (GTM 2.0) productivity, scalability and safety improvements.