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. 2018:165:1-8.
doi: 10.1007/10_2017_39.

An Introduction to "Recent Trends in the Biotechnology Industry: Development and Manufacturing of Recombinant Antibodies and Proteins"

Michael Pohlscheidt  1 , Robert Kiss  2 , Uwe Gottschalk  2
Affiliations

An Introduction to "Recent Trends in the Biotechnology Industry: Development and Manufacturing of Recombinant Antibodies and Proteins"

Michael Pohlscheidt et al. Adv Biochem Eng Biotechnol. 2018.

Abstract

The production of the first therapeutic proteins in the early 1980s heralded the launch of the biopharmaceuticals industry. The number of approved products has grown year on year over the past three decades to now represent a significant share of the entire pharmaceuticals market. More than 200 therapeutic proteins have been approved, approximately a quarter of which are represented by monoclonal antibodies and their derivatives. In 2016, the list of the top 15 best-selling drugs included more than eight biologics and in 2020 the trend will continue, with more than 50% of the top 20 best-selling drugs predicted to be biologics. From 1986 to 2014 several first-in-class, advance-in-class, and breakthrough designated therapeutic options were approved, with advanced therapies such as immuno-oncology and cell-based therapies being approved for several indications.

Keywords: Antibody formats and evolution; Biotechnology; Cell culture; PAT; Processing technologies; QbD.

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