Jump to main content
Jump to site search
Access to RSC content Close the message box

Continue to access RSC content when you are not at your institution. Follow our step-by-step guide.


Issue 3, 2020
Previous Article Next Article

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

Author affiliations

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)

Back to tab navigation

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

Social activity

Search articles by author

Spotlight

Advertisements