Process Development For CGT: How Soon Is Too Soon? (Geleen)

Cell and gene therapy has a persistent tension: clinical data from academic centers can look commercial-grade at Phase II, while CMC work often remains preclinical. Regulators offer no exemption. This panel, chaired by Anthony Davies, founder and CEO of Dark Horse Consulting, brings together Eric Rutjens, Chief Technology Officer at CenCell Therapeutics; Chaminda Salgado, VP and head of CMC strategy at T-Cypher Bio; and Behnam Ahmadian Baghbaderani, Global Head of Process Development at Lonza. They debate what the D in CDMO should deliver, the two breakpoints where process decisions become costly to reverse, and where automation and analytics fit. Public examples from approved and delayed products ground the discussion, and the group takes a pointed look at how much data is too much. Watch the discussion to hear where the panelists agree, and where they do not.