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Strategien zur validierten Quantifizierung von Protein-Wirkstoffen und proteinogenen Verunreinigungen

Katja Aschermann, Andreas Wattenberg

Protagen AG, Dortmund (Germany)

Korrespondenz: Andreas Wattenberg, Protagen AG, Otto-Hahn-Str. 15, 44227 Dortmund (Germany), e-mail: info@protagen.de

Strategies for Validated Quantification of Protein Drug Substances and Protein Impurities

In the past years the introduction of proteins and antibodies as drugs has accelerated the development of pharmaceutical substances. This poses a large challenge to the pharmaceutical industry because proteins are much more complex than classical, chemically synthesised products.
One main part of this challenge is the accurate quantification of proteins. Although an accurate, robust and reproducible method of quantification is indispensable for safe drug production, such method does not exist so far.
This article gives an overview on currently available methods of protein quantification and discusses their strengths and weaknesses. Special focus is put on accuracy, reproducibility, robustness and statistical reliability.

Key words GMP • Proteine, Quantifizierung • Validierung • Wirkstoffe