John Liddell, Chief Technologist at the Centre for Process Innovation (CPI), writes about the challenges associated with gene therapy products, which constitute a major portion of the overall cell and gene therapy market.
What are some of dos and don’ts on starter materials for CGT manufacturing? Raw materials play a vital role in the development of cell and gene (CGT) therapies.
Mike Brewer, director, global principal consultant, regulatory, bioproduction, Thermo Fisher Scientific, spoke to BioPharma-Reporter about some of dos and don’ts on starter materials for CGT manufacturing.
His advice is particularly targeted at newer entrants to the CGT space, those at the at the preclinical stage, that might not have the same level of regulatory expertise that more established players in the biopharma industry would automatically have accrued.
Critical concerns have to be addressed around the quality and consistency of all the products used in CGT manufacturing processes, said Brewer.
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