Vodiakova Marina A, Sayfutdinova Aliya R, Melnikova Ekaterina V, Goryaev Artem A, Sadchikova Natalia P, Gegechkori Vladimir I, Merkulov Vadim A
FSBI "Scientific Centre for Expert Evaluation of Medicinal Products" of the Ministry of Health of the Russian Federation , Moscow , 127051 , Russia.
I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University) , 119991 Moscow , Russia . Email:
RSC Med Chem. 2020 Feb 19;11(3):349-357. doi: 10.1039/c9md00529c. eCollection 2020 Mar 1.
Donor biological materials and excipients of animal origin are important components in the production of biomedical cell products (BMCPs). Their quality ensures the stability, safety, effectiveness and purity of the final product. This review discusses quality requirements for biological excipients intended for the production of biomedical cell products, in terms of the necessary information that should be included in the BMCP registration dossier during state registration and is subject to expert assessment during quality control. Considering that there is currently no production of biomedical cell products in the Russian Federation, the authors considered international approaches to ensuring the safety of donor material and excipients for the manufacturing of human cell- and tissue-based products (BMCP analogues).
供体生物材料和动物源辅料是生物医学细胞产品（BMCPs）生产中的重要组成部分。它们的质量确保了最终产品的稳定性、安全性、有效性和纯度。本综述讨论了用于生产生物医学细胞产品的生物辅料的质量要求，涉及在国家注册期间BMCP注册档案中应包含的必要信息，以及在质量控制过程中需接受专家评估的内容。鉴于俄罗斯联邦目前尚无生物医学细胞产品生产，作者考虑了确保用于制造人细胞和组织产品（BMCP类似物）的供体材料和辅料安全性的国际方法。
