Raw materials in cell therapy: start right early in process development

All drug products, whether they are small molecule, monoclonal antibodies or cell therapy share some of the same issues in drug development, including raw materials. Certainly, accelerated speed through clinical phases and into commercial manufacturing is something all sectors of drug manufacturing must balance with the ability to provide a robust production process. This article will discuss raw material issues specific to cellular therapy products but also common across all types of drug products. Raw and ancillary material regulations and guidelines can be further understood by reading regulatory publications such as USP <1043>, EP 5.2.L2 and new ISO Technical Standard 20399.

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