Clinical Grade vs GMP Grade Terminology for Ancillary Materials

Are you purchasing ancillary materials such as Human Platelet Lysate for your cell therapy manufacturing protocol? 

Confused by the Clinical grade and GMP grade terminology used by vendors of Ancillary Materials? 

A recent publication by Solomon et al. in Cytotherapy, titled “Current perspectives on the use of ancillary materials for the manufacture of cellular therapies” addresses the inconsistent use of such terms across the cell therapy industry. Some of the highlights from the publication are discussed below to help researchers who are sourcing hPL cell therapy manufacturing. 

Ancillary materials (AMs) are components used for manufacturing cell therapy products but are not intended to be part of the final product. Since AMs can significantly impact the efficacy of the final product or the success of a clinical trial or product development, they should be carefully selected and qualified during the process development phase. It is therefore important for AM users to fully understand the claims made by suppliers and hold suppliers accountable for AM labeling and marketing claims. 

Clinical Grade is used to describe products or materials that are suitable for direct therapeutic use, such as, injectable grade. Such materials are required to show to safety and efficacy for human use through appropriate clinical trials and regulatory approvals. Usually, clinical-grade products are approved as drugs by regulators, and labeling or product documentation should state sterility and safety profile. 

​On the other hand, GMP grade or cGMP grade refers to products manufactured under Current Good Manufacturing Practices which require manufacturers ensure that their products are traceable, safe, pure and effective. This term therefore denotes that a product has been prepared under cGMP guidelines to ensure proper design, monitoring and control of the manufacturing processes, facilities and the final product. Regional differences exist where some national regulatory agencies provide GMP certificates to manufacturers of GMP AMs and others do not. 

Therefore, when a manufacturer contacts a vendor of a specific AM and comes across the claim “Clinical Grade”, they should ask the vendor for the product’s specific regulatory approvals and safety data. On the other hand, if an AM is labeled as a GMP grade product, the user should qualify the vendor to confirm that the product was manufactured under a quality system compliant to cGMP guidelines. Compass Biomedical offers GMP grade PLUS™ Human Platelet Lysate that is manufactured under a robust quality system. We have been successfully audited by numerous clients who use GMP grade PLUS™ as an ancillary material in their cell therapy protocols. Our quality and regulatory teams are available to assist new clients with quality system audits and obtaining faster approval for clinical trials by using the PLUS™ Drug Master File on record with the US FDA.

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Reference:

1. Current perspectives on the use of ancillary materials for the manufacture of cellular therapies. Cytotherapy, 2016; 18: 1-12