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

Vodiakova, Marina A; Sayfutdinova, Aliya R; Melnikova, Ekaterina V; Goryaev, Artem A; Sadchikova, Natalia P; Gegechkori, Vladimir I; Merkulov, Vadim A

Vodiakova, Marina A; Sayfutdinova, Aliya R; Melnikova, Ekaterina V; Goryaev, Artem A; Sadchikova, Natalia P; Gegechkori, Vladimir I; Merkulov, Vadim A.

Afiliación

Vodiakova MA; FSBI "Scientific Centre for Expert Evaluation of Medicinal Products" of the Ministry of Health of the Russian Federation , Moscow , 127051 , Russia.
Sayfutdinova AR; FSBI "Scientific Centre for Expert Evaluation of Medicinal Products" of the Ministry of Health of the Russian Federation , Moscow , 127051 , Russia.
Melnikova EV; I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University) , 119991 Moscow , Russia . Email: vgegechkori@gmail.com.
Goryaev AA; FSBI "Scientific Centre for Expert Evaluation of Medicinal Products" of the Ministry of Health of the Russian Federation , Moscow , 127051 , Russia.
Sadchikova NP; FSBI "Scientific Centre for Expert Evaluation of Medicinal Products" of the Ministry of Health of the Russian Federation , Moscow , 127051 , Russia.
Gegechkori VI; I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University) , 119991 Moscow , Russia . Email: vgegechkori@gmail.com.
Merkulov VA; I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University) , 119991 Moscow , Russia . Email: vgegechkori@gmail.com.

RSC Med Chem ; 11(3): 349-357, 2020 Mar 01.

Article en En | MEDLINE | ID: mdl-33479640

RESUMEN

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).

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: RSC Med Chem Año: 2020 Tipo del documento: Article País de afiliación: Rusia Pais de publicación: Reino Unido

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