Commercial Aspects of Pharmaceutical Protein Production in Plants

TLDR

Plant-based systems have produced recombinant pharmaceutical proteins, yet only a few have transitioned from experimental platforms to viable commercial processes due to technical, economic, and regulatory challenges. This article examines the commercial aspects of molecular farming that are necessary to make plant-based production more competitive and attractive to industry. The recent approval of the first plant‑derived recombinant pharmaceutical protein marks a new era in which plants meet all commercial manufacturing demands and can displace established platform technologies in niche markets. 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. Keywords: Molecular farming, platform technology, innovation, disruptive technology, biopharmaceutical, GMP.