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Biotechnologische Pharmawirkstoffe

Überblick über spezifische Eigenschaften, Besonderheiten bei Herstellung, Analytik und Zulassung

Thomas Schäfer

Sanofi-Aventis Deutschland GmbH, Frankfurt/Main

Korrespondenz: Dr. Thomas Schäfer, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Bldg. D710, Room 204, 65926 Frankfurt/Main (Germany), e-mail: Thomas.Schaefer@sanofi-aventis.com

Biotechnological Active Pharmaceutical Ingredients / An overview of the specific properties and characteristics of the manufacturing process, analytics and marketing authorisation

Active ingredients and products derived from biotechnological processes have gained a significant place in modern pharmaceutics. There are at least two reasons for this: the constantly growing knowledge of the biochemical processes in a cell and the often very much more target-directed therapeutic profile of these substances compared with chemical active ingredients.
The manufacture of active ingredients or their precursors (e.g. antibiotics) using classical fermentation processes and the industrial production of recombinant proteins (e.g. human insulin and erythropoietin) using genetically modified organisms (GMO) are becoming increasingly more important.
Compared with chemically synthesized active ingredients, the successful introduction of biotechnological products onto the market requires specific knowledge particularly in the manufacturing process, analytics and registration procedure.
The following article presents an overview of the typical properties of biotechnological active ingredients, explains the characteristics relating to the manufacture, analytics and marketing authorisation and covers the specifics of inspections of plants producing biotechnological active ingredients by the authorities.

Key words Biopharmazeutika • Biosimilars • ELISA • Genetisch modifizierte Organismen • GMO • Rekombinante Wirkstoffe • Zellbank