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Protein Immobilization by Crystallization and Precipitation: An Alternative to Lyophilization

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Current Trends in Monoclonal Antibody Development and Manufacturing

Part of the book series: Biotechnology: Pharmaceutical Aspects ((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.

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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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  1. Boehringer Ingelheim Pharma GmbH & Co.KG, Biberach, Germany

    Karoline Bechtold-Peters

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  1. Karoline Bechtold-Peters
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Correspondence to Karoline Bechtold-Peters .

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  1. Genentech Inc., DNA Way 1, San Francisco, 94080, U.S.A.

    Steven J. Shire

  2. Omeros Corporation, Fifth Ave Ste 2600 1420, Seattle, 98101, U.S.A.

    Wayne Gombotz

  3. Boehringer Ingelheim Pharma KG, Birkendorfer Str. 65, Biberach, 88397, Germany

    Karoline Bechtold-Peters

  4. Genentech, Inc., DNA Way 1, South San Francisco, 94080, U.S.A.

    James Andya

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Bechtold-Peters, K. (2010). Protein Immobilization by Crystallization and Precipitation: An Alternative to Lyophilization. In: Shire, S., Gombotz, W., Bechtold-Peters, K., Andya, J. (eds) Current Trends in Monoclonal Antibody Development and Manufacturing. Biotechnology: Pharmaceutical Aspects, vol XI. Springer, New York, NY. https://doi.org/10.1007/978-0-387-76643-0_10

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