Production of biomedical cell products: requirements for the quality of donor material and excipients of animal origin (review),RSC Medicinal Chemistry

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Production of biomedical cell products: requirements for the quality of donor material and excipients of animal origin (review)
RSC Medicinal Chemistry ( IF 4.1 ) Pub Date : 2020-02-19 , DOI: 10.1039/c9md00529c
Marina A. Vodiakova _{1,

2,

3} , Aliya R. Sayfutdinova _{1,

2,

3,

4,

5} , Ekaterina V. Melnikova _{1,

2,

3} , Artem A. Goryaev _{1,

2,

3} , Natalia P. Sadchikova _{3,

4,

5} , Vladimir I. Gegechkori _{2,

3,

4,

5,

6} , Vadim A. Merkulov _{1,

2,

3}

Affiliation

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).

中文翻译：

生物医学细胞产品的生产：对供体材料和动物源性赋形剂质量的要求（综述）

供体的生物材料和动物来源的赋形剂是生物医学细胞产品（BMCP）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。这篇评论讨论了用于生产生物医学细胞产品的生物赋形剂的质量要求，包括在国家注册期间应包含在BMCP注册卷宗中的必要信息，并在质量控制期间接受专家评估。考虑到俄罗斯联邦目前没有生产生物医学细胞产品，作者考虑了确保生产人类细胞和组织产品（BMCP类似物）的供体材料和赋形剂安全的国际方法。

更新日期：2020-02-19

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