Production of biomedical cell products: requirements for the quality of donor material and excipients of animal origin (review).
Journal
RSC medicinal chemistry
ISSN: 2632-8682
Titre abrégé: RSC Med Chem
Pays: England
ID NLM: 101759460
Informations de publication
Date de publication:
01 Mar 2020
01 Mar 2020
Historique:
received:
11
11
2019
accepted:
28
01
2020
entrez:
22
1
2021
pubmed:
23
1
2021
medline:
23
1
2021
Statut:
epublish
Résumé
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).
Identifiants
pubmed: 33479640
doi: 10.1039/c9md00529c
pii: c9md00529c
pmc: PMC7580781
doi:
Types de publication
Journal Article
Review
Langues
eng
Pagination
349-357Informations de copyright
This journal is © The Royal Society of Chemistry 2020.
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