The biopharmaceutical sector, particularly cell and gene therapy (CGT), has experienced substantial growth due to continuous technological advancements. As biologics, including CGT, become integral to next-generation medicine, ensuring the safety of biological medicines and the raw materials used in their manufacturing is paramount.
The FDA emphasizes the use of “the highest quality” materials in CGT manufacturing. The International Pharmaceutical Regulatory Plan Cell Therapy Working Group has provided guidance on the importance of utilising high-quality raw materials in the production of licensed human CGT products.
Quality assurance in raw materials is a critical aspect for cell therapy manufacturers, whether they develop materials in-house or source them externally. Steps must be taken before initiating clinical research and submitting investigational new drug (IND) applications. This includes evaluating quality control methods and standards for raw materials such as cytokines and growth factors.
These standards and methods are derived from various sources, including pharmacopeial methods established by organizations like the USP and the European Directorate for the Quality of Medicines and Healthcare. Additionally, non-pharmacopeial methods, such as those outlined in International Conference on Harmonization (ICH) documents, provide supplementary analytical approaches for assessing specific product characteristics and manufacturing processes.
Commercial products adhering to these standards are often labelled as ‘GMP-grade’ or ‘cGMP-grade,’ indicating compliance with Good Manufacturing Practices. However, the responsibility for due diligence falls on cell therapy manufacturers when selecting suppliers for these products.
This article highlights three crucial aspects of GMP-grade quality control systems necessary for meeting IND requirements, with a focus on raw material safety. Evaluation strategies include contaminant control and detection methods to minimize residues that could harm the final product, encompassing sterility testing for contaminants such as mycoplasma, endotoxins, residual host-cell DNA, and proteins.
