Commercial aspects of pharmaceutical protein production in plants

Current Pharmaceutical Design
Rainer FischerRichard M Twyman

Abstract

Many different plant-based systems have been used to produce recombinant pharmaceutical proteins but only a small number have made the leap from an experimental platform to a viable commercial process. This reflects a combination of factors, principally the technical issues that must be addressed to achieve competitive performance, the economic principles that need to be satisfied to ensure manufacturing processes are financially viable and sustainable, and the regulatory demands that must be met to ensure that pharmaceuticals manufactured in plants are safe, efficacious and meet the quality standards demanded by the regulators. With the recent approval of the first plant-derived recombinant pharmaceutical protein designated for human use, we are now entering a new era in which plants not only meet all the demands of a commercial pharmaceutical manufacturing process but also provide unique benefits that allow the displacement of established platform technologies in niche markets. In this article, we consider the commercial aspects of molecular farming, specifically those required to make plants more competitive and attractive to industry.

Citations

Apr 20, 2014·BioMed Research International·Matilde MerlinLinda Avesani
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Jul 23, 2014·Biotechnology Letters·Maite SabalzaTeresa Capell
Sep 5, 2014·Plant Cell Reports·David Rhys Thomas, Amanda Maree Walmsley
Dec 3, 2015·Biotechnology Advances·Nikolay VasilevAndreas Schiermeyer
Jan 9, 2016·Protein Expression and Purification·Ewelina ŁojewskaTomasz Sakowicz
Jul 16, 2015·Plant Biotechnology Journal·Joshua L FuquaKenneth E Palmer
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Mar 26, 2016·Frontiers in Bioengineering and Biotechnology·Naomichi FujiuchiRyo Matsuda
Apr 30, 2015·Biotechnology Advances·J F BuyelR Fischer
Apr 7, 2015·Trends in Biotechnology·Menachem Moshelion, Arie Altman
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