Zobrazeno 1 - 2
of 2
pro vyhledávání: '"C. E. F. Nieuweboer"'
Autor:
F. A. C. Van Engelenburg, C. E. F. Nieuweboer, O. J. M. Bos, Hanneke Schuitemaker, J. Over, D. G. J. Sunye
Publikováno v:
Biologicals, 26(4), 267-276. Academic Press Inc.
To assess the virus reducing capacity of Cohn's cold ethanol fractionation process for the production of intravenous (IVIg) and intramuscular (IMIg) immunoglobulin products, and treatment of these products at pH 4, a validation study of virus removal
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8820f2043504dc7e06c1b22be9224566
https://doi.org/10.1006/biol.1998.0148
https://doi.org/10.1006/biol.1998.0148
Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation
