From Process Understanding to Process Control: Application of PAT ont he cultivation of Bordetella pertussis for a whole cell vaccine - Couverture souple

Streefland, Mathieu

 
9783838361314: From Process Understanding to Process Control: Application of PAT ont he cultivation of Bordetella pertussis for a whole cell vaccine
Couverture souple
ISBN 10 : 3838361318 ISBN 13 : 9783838361314
Editeur : LAP LAMBERT Academic Publishing, 2010

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.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Présentation de l'éditeur

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.

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Éditeur
LAP LAMBERT Academic Publishing
Date d'édition
2010
Langue
anglais
ISBN 10 
3838361318
ISBN 13 
9783838361314
Reliure
Broché
Nombre de pages
172
Coordonnées du fabricant
non disponible
Personne responsable
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