The manufacture of advanced therapy medicinal products (ATMPs) is critically impacted by the quality of the raw materials (RMs) used. Following the need expressed by stakeholders to establish a certification scheme for biological RMs used in the manufacture of ATMPs, the European Pharmacopoeia (Ph. Eur.) Cell Therapy Products Working Party (CTP WP) conducted an informal investigation with the aim of issuing a technical opinion on the feasibility of such a certification scheme. Seven RM Drug Master Files were reviewed for compliance of the RM with Ph. Eur. general chapter 5.2.12. Raw materials of biological origin for the production of cell-based and gene therapy medicinal products by members of the CTP WP who were representatives of competent authorities and experienced in the evaluation of RMs for ATMPs. This article presents the results of these case studies, including the potential benefits and concerns identified by the experts. It was concluded that it would be technically feasible, albeit challenging, to set up a certification system for RMs of biological origin against chapter 5.2.12. Although the establishment of such a scheme is currently perceived by some CTP WP members as premature, it could potentially be beneficial for all stakeholders (RM manufacturers, ATMP manufacturers and assessors).
Keywords: ATMP; European Pharmacopoeia; certification system; general chapter 5.2.12; raw materials.
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