From Process Understanding to Process Control

Language: English

Published by LAP LAMBERT Academic Publishing Jun 2010, 2010

3838361318 / 9783838361314

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This item is printed on demand - Print on Demand Titel. Neuware -A licensed pharmaceutical process is required to be executed within the validated ranges throughout the lifetime of product manufacturing. Changes to the process usually require the manufacturer to demonstrate that the safety and efficacy of the product remains unchanged. Recent changes in the regulations for pharmaceutical processing allow broader ranges of process settings to be submitted for regulatory approval, when a manufacturer can scientifically support the rationale for these settings. The combined validated ranges of settings for process parameters constitute the so called process design space. In this thesis, the applicability of this concept of the process design space is investigated for the cultivation process step for a vaccine against whooping cough disease. This thesis demonstrates that the general principles of PAT and process design space are general and can even be applied to an undefined biological product such as a whole cell vaccine.VDM Verlag, Dudweiler Landstraße 99, 66123 Saarbrücken 172 pp. Englisch.…

Seller Inventory # 9783838361314

Title
From Process Understanding to Process Control
Author
Mathieu Streefland
Publisher
LAP LAMBERT Academic Publishing Jun 2010
Publication year
2010
Condition
Neu
Binding
Taschenbuch
Language
English
ISBN 10
3838361318
ISBN 13
9783838361314
Item weight
274 grams
Dimensions
220x150x11 mm

buchversandmimpf2000

Emtmannsberg, BAYE, Germany

5-star seller

AbeBooks seller since January 23, 2017

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