Title:Commercial Aspects of Pharmaceutical Protein Production in Plants
Volume: 19
Issue: 31
Author(s): Rainer Fischer, Stefan Schillberg, Johannes F. Buyel and Richard M. Twyman
Affiliation:
Keywords:
Molecular farming, platform technology, innovation, disruptive technology, biopharmaceutical, GMP.
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.
