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Issue 3, 2020
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Production of biomedical cell products: requirements for the quality of donor material and excipients of animal origin (review)

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Abstract

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).

Graphical abstract: Production of biomedical cell products: requirements for the quality of donor material and excipients of animal origin (review)

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Article information


Submitted
11 Nov 2019
Accepted
28 Jan 2020
First published
19 Feb 2020

RSC Med. Chem., 2020,11, 349-357
Article type
Review Article

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

M. A. Vodiakova, A. R. Sayfutdinova, E. V. Melnikova, A. A. Goryaev, N. P. Sadchikova, V. I. Gegechkori and V. A. Merkulov, RSC Med. Chem., 2020, 11, 349
DOI: 10.1039/C9MD00529C

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