Bovine serum is widely used in the manufacture of human and veterinary medicinal products, for example as a supplement in cell culture media for the production of vaccines (both human and veterinary) and advanced therapy medicinal products (ATMPs). The European Pharmacopoeia (Ph. Eur.) monograph on Bovine serum (2262) provides general quality requirements for bovine serum. First published in Supplement 5.4 (implementation date 1 April 2006), the monograph has been revised once to lower the haemoglobin limit in order to better reflect the current practice.

During its 179th Session in June 2024, the European Pharmacopoeia Commission (EPC) decided to entrust the Bovine Serum Working Party (BSR WP) with the overhaul of Bovine serum monograph to update its requirements. The EPC also mandated the BSR WP to assess whether new Ph. Eur. texts pertaining to bovine and human sera should be elaborated.

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