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Sponsor Led Roundtable: Addressing Manufacturing Challenges with Gene-Editing Technologies for iPSC Therapeutics

25 Jun 2024
Salon A
iPSCs Technology
Sponsor Led Roundtable: Addressing Manufacturing Challenges with Gene-Editing Technologies for iPSC Therapeutics
  • What are the manufacturing implications of the recent FDA guidelines from January 2024 on “Human Gene Therapy Products Incorporating Human Genome Editing”?
  • How do manufacturing requirements differ for gene-editing of master cell banks versus drug substances/drug products?
  • How can gene-editing technologies be manufactured to meet appropriate quality attributes?
Industry Expert
Robert Margolin, VP of Commercial - Akron Biotech