Developments in Biological Standardization. Siehe auch: Progress in Immunobiological Standardization / Symposia Series in Immunobiological Standardization / Viral Saftety and Evaluation of Viral Clearane from Biopharmaceutical Products

National Institute of Health, Bethesda. Md., June 1995

Fred Brown, A S Lubiniecki (Herausgeber)

Buch | Softcover

X, 350 Seiten

1996
Karger, S (Verlag)
978-3-8055-6391-8 (ISBN)

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Developments in Biological Standardization. Siehe auch: Progress in Immunobiological Standardization / Symposia Series in Immunobiological Standardization; Bd 88

Assurance that biopharmaceuticals do not contain unwanted infectious agents is a vital safety consideration, in the use of these products. This can only be ensured by careful screening of the cells and other materials used in their production, and subsequent testing of the final product. This publication reports the proceedings of an international conference which focused on the methods of how to avoid contamination of cell cultures with virus during the production process of biologicals, with the aim of providing harmonized guidelines to ensure product safety. Scientists from industry and regulatory agencies present updates on the current state of knowledge about assays for viral contamination and procedures for inactivation and removal. Risks associated with the processing of biopharmaceuticals are identified, and data on the actual experiences of testing and industrial laboratories are represented and discussed in the context of the clinical setting. Drawing together a wealth of new data, this book will be essential reading for all scientists concerned with the development, production and quality control of biopharmaceutical products.

Reihe/Serie	Developments in Biological Standardization. Siehe auch: Progress in Immunobiological Standardization / Symposia Series in Immunobiological Standardization ; BD 88 \| 1.610
Zusatzinfo	33 figs., 73 tab.
Sprache	deutsch
Maße	170 x 240 mm
Gewicht	690 g
Einbandart	Paperback
Themenwelt	Naturwissenschaften ► Biologie ► Allgemeines / Lexika
Schlagworte	Biopharmazie • Cell Biology • HC/Biologie/Allgemeines, Lexika • immunology • Virus
ISBN-10	3-8055-6391-4 / 3805563914
ISBN-13	978-3-8055-6391-8 / 9783805563918
Zustand	Neuware