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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.

Mike brewerKasey kimeHealth canadaDevices agencyThermo fisher scientificDrug master fileMedical devices agencyJapanese standardBiological ingredientsGene therapy insightsUpstream processingCell amp gene therapiesEparation amp purificationCell culture mediaCell therapyGene therapy