What are some of the dos and don’ts on starter materials for CGT manufacturing?

Drugs

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.

In the specific case of cell therapy and cell culture media used, there is a tight relationship between the process and the product: the cell expansion stage is a critical step and generally live cells, that are the treatment, don’t go through an intensive purification process following the cell expansion stage prior to infusion in the patient.

One of the key products in the cell therapy process is the cell culture media used for the expansion of the modified cells. That product must be manufactured in a compliant manner, the manufacturer must follow appropriate practices, procedures, incorporating all the necessary controls and documentation, and meeting the standards that would be expected in the industry from the manufacturing side and also by regulatory agencies reviewing an application for approval of a product and the manufacturing process around that product:

“The materials selected for expansion must be fit for the intended purpose and manufactured in a way that regulators will accept. As the T-cells do not go through a rigorous purification process, some components of the cell culture media can potentially be part of the final dosage form that goes into the patient.

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