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Protein Immobilization by Crystallization and Precipitation: An Alternative to Lyophilization

  • Karoline Bechtold-Peters
Chapter
Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume XI)

Abstract

Of the 26 currently approved drug products containing monoclonal antibodies as active substance for therapy or in vivo diagnosis about a quarter are freeze-dried preparations that require reconstitution before use (product survey as of December 2008) (Wang et al. 2007).

cGMP compliant freeze drying units have been available for several decades and biopharmaceutical companies have at their disposal a selection of modern lyophilizers as part of their standard operating equipment. Lyophilizers are operated aseptically by being equipped with clean in place (CIP)/steam in place (SIP) technology, utilizing sterile air or sterile nitrogen, and by stoppering the vials still in the lyophilizer through collapsing shelves. Automated loading or unloading or the coupling of the lyophilizer to filling isolators are becoming common at the production scale.

Keywords

Supercritical Fluid Carrier Material Amine Oxide Ethyl Lactate Protein Crystallization 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgments:

Udo Heinzelmann, Torsten Schultz-Fademrecht and Beate Fischer, Boehringer Ingelheim Pharma GmbH&Co.KG, as well as Johann Patridge, Jan Vos und Barry Moore, XstalBio Ltd.

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Copyright information

© American Association of Pharmaceutical Scientists 2010

Authors and Affiliations

  1. 1.Boehringer Ingelheim Pharma GmbH & Co.KGBiberachGermany

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