EDQM Intensifies Focus on Biotech; USP Also Advancing Biotech Coverage

In mid-February, the European Directorate for the Quality of Medicines & HealthCare (EDQM) announced an ambitious set of efforts aimed at ensuring that the European Pharmacopeia (Ph. Eur.) texts and monographs appropriately cover biologic products, including cellular and gene transfer products and host cell-derived proteins.

To that end, two “working parties” have been formed focusing separately on raw materials for cellular and gene transfer products and the development and quantitation of host cell-derived proteins.

The cellular and gene transfer working party will create a text on raw materials for the production of those product types, including antibodies, basal media (for cell culture), serum/serum replacements and growth factors. “Specialists” in the production and development of cellular and gene transfer products and their raw materials, and “experts” in the assessment of applications for clinical trials and marketing authorizations, will be part of the group.

The working party focusing on host cell-derived proteins will provide recommendations for the development, validation and use of in-house or commercial kits or test methods for the detection and quantification of host-cell proteins.

The two working parties were created at the 141st session of the Ph. Eur. Commission in November, 2011, and specialists will be nominated at its next session in April.

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