Volume 1, Issue 2 p. 164-186
Review

Manufacturing of recombinant therapeutic proteins in microbial systems

Klaus Graumann Dr.

Corresponding Author

Klaus Graumann Dr.

Novartis Biopharmaceutical Operations, Sandoz GmbH, Kundl, Austria

Novartis Biopharmaceutical Operations, Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria, Fax: +43 (0) 5338 200 461Search for more papers by this author
Andreas Premstaller

Andreas Premstaller

Novartis Biopharmaceutical Operations, Sandoz GmbH, Kundl, Austria

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First published: 07 February 2006
Citations: 139

Abstract

Recombinant therapeutic proteins have gained enormous importance for clinical applications. The first recombinant products have been produced in E. coli more than 20 years ago. Although with the advent of antibody-based therapeutics mammalian expression systems have experienced a major boost, microbial expression systems continue to be widely used in industry. Their intrinsic advantages, such as rapid growth, high yields and ease of manipulation, make them the premier choice for expression of non-glycosylated peptides and proteins. Innovative product classes such as antibody fragments or alternative binding molecules will further expand the use of microbial systems. Even more, novel, engineered production hosts and integrated technology platforms hold enormous potential for future applications. This review summarizes current applications and trends for development, production and analytical characterization of recombinant therapeutic proteins in microbial systems.