Successful cell and gene therapy manufacturing is dependent on high-quality reagents to ensure safety, efficacy, and batch-to-batch consistency. Despite arising guidance in this area, there is no official certification given for the manufacturing of GMP grade raw materials, neither in Europe nor in the USA.

Since this kind of GMP certification is not likely to be announced in the near future, manufacturers of raw materials have to identify critical quality requirements to meet increasing quality and safety concerns.

We propose and apply the following three critical quality standards for the manufacturing of GMP grade raw materials:

SAFETY

GMP COMPLIANCE

REGULATORY COMPLIANCE & SUPPORT

SAFETY

• Raw material and supplier qualification

• ADCF Preclinical and GMP cytokines

• Serum-free media

GMP COMPLIANCE

• Documented evidence of purity, potency, consistency, and stability

REGULATORY COMPLIANCE & SUPPORT

• Full documentation

• Compliance to USP <1043>, Ph. Eur. 5.2.12, ISO TS 20399

• Expert technical and regulatory support

• Raw material and supplier qualification

• ADCF Preclinical and GMP cytokines

• Serum-free media

• Documented evidence of purity, potency, consistency, and stability

• Full documentation

• Compliance to USP <1043>, Ph. Eur. 5.2.12, ISO TS 20399

• Expert technical and regulatory support

>>>        Suitability for Intended Use in Commercial Cell Therapy Manufacturing        >>>

Sartorius CellGenix has a rich history of producing premium-grade raw and ancillary materials; our GMP grade products allow for the safe use in clinical trials and commercial manufacturing in accordance with the guidelines set by the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the global ISO Technical Standard 20399.

Active partner in regulatory committees

To stay up-to-date and help improve regulatory guidance we are actively involved in many regulatory initiatives and discussions. Together with the USP we have written the first version of USP <92> and were actively involved in the discussions for the setup of Ph. Eur. General Chapter 5.2.12.

We also actively contributed to the ISO Technical Committee TC276. This committee published the only global best practice guide for raw materials intended for suppliers and users, the ISO technical standard 20399.

CellGenix® GMP Cytokines

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CellGenix® GMP Serum-free Media

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Raw Material Validation: ask the experts

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