From Process Understanding to Process Control: Application of PAT ont he cultivation of Bordetella pertussis for a whole cell vaccine - Softcover
Synopsis
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.
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From Process Understanding to Process Control
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LAP LAMBERT Academic Publishing Jun 2010, 2010
ISBN 10: 3838361318
ISBN 13: 9783838361314
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Taschenbuch. Condition: Neu. This item is printed on demand - it takes 3-4 days longer - 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. 172 pp. Englisch. Seller Inventory # 9783838361314
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From Process Understanding to Process Control
Published by
LAP LAMBERT Academic Publishing, 2010
ISBN 10: 3838361318
ISBN 13: 9783838361314
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Condition: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Autor/Autorin: Streefland MathieuMathieu Streefland has almost 10 years experience in biopharma process development with an interest in applying PAT/QbD principles. He received a MSc degree in Biopharmaceutical Sciences from Leiden University an. Seller Inventory # 5416483
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From Process Understanding to Process Control | Application of PAT ont he cultivation of Bordetella pertussis for a whole cell vaccine
Published by
LAP LAMBERT Academic Publishing, 2010
ISBN 10: 3838361318
ISBN 13: 9783838361314
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Taschenbuch. Condition: Neu. From Process Understanding to Process Control | Application of PAT ont he cultivation of Bordetella pertussis for a whole cell vaccine | Mathieu Streefland | Taschenbuch | 172 S. | Englisch | 2010 | LAP LAMBERT Academic Publishing | EAN 9783838361314 | Verantwortliche Person für die EU: BoD - Books on Demand, In de Tarpen 42, 22848 Norderstedt, info[at]bod[dot]de | Anbieter: preigu. Seller Inventory # 101073093
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From Process Understanding to Process Control
Published by
LAP LAMBERT Academic Publishing Jun 2010, 2010
ISBN 10: 3838361318
ISBN 13: 9783838361314
New
Taschenbuch
Seller: buchversandmimpf2000, Emtmannsberg, BAYE, Germany
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Taschenbuch. Condition: Neu. 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
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From Process Understanding to Process Control : Application of PAT ont he cultivation of Bordetella pertussis for a whole cell vaccine
Published by
LAP LAMBERT Academic Publishing, 2010
ISBN 10: 3838361318
ISBN 13: 9783838361314
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Taschenbuch. Condition: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - 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. Seller Inventory # 9783838361314
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From Process Understanding to Process Control: Application of PAT ont he cultivation of Bordetella pertussis for a whole cell vaccine
Published by
LAP LAMBERT Academic Publishing, 2010
ISBN 10: 3838361318
ISBN 13: 9783838361314
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