Overview: In this Q&A, Cell Process Development Scientist at AGC Biologics Cell and Gene Center of Excellence Sara Morlacchi, provides her expert analysis on the current state of the cell therapy space, the growth of the industry, and barriers for cost and accessibility. Sara and the team at the site recently helped a developer reach commercial approval with the FDA for their cell therapy product – Orchard Therapuetics’ Lenmeldy™.
Q: Cell therapies use a variety of immune and stem cells and are either autologous or allogeneic. Is there a common platform process for manufacturing that can be optimized to reflect the different starting points and sets of overarching challenges?
A: Cell therapy drug products offer a proven therapeutic approach with the potential to treat many life-threatening diseases through powerful modes of action. Those currently in clinical trials or with commercial…
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