Title:Target Product Selection - Where Can Molecular Pharming Make the Difference?
Volume: 19
Issue: 31
Author(s): Mathew J. Paul, Audrey Y.H. Teh, Richard M. Twyman and Julian K-C. Ma
Affiliation:
Keywords:
Plant biotechnology, monoclonal antibodies, vaccines, plants.
Abstract: Four major developments have taken place in the world of Molecular Pharming recently. In the USA, the DARPA initiative
challenged plant biotechnology companies to develop strategies for the large-scale manufacture of influenza vaccines, resulting in a successful
Phase I clinical trial; in Europe the Pharma-Planta academic consortium gained regulatory approval for a plant-derived monoclonal
antibody and completed a first-in-human phase I clinical trial; the Dutch pharmaceutical company Synthon acquired the assets of
Biolex Therapeutics, an established Molecular Pharming company with several clinical candidates produced in their proprietary LEX
system based on aquatic plants; and finally, the Israeli biotechnology company Protalix Biotherapeutics won FDA approval for the commercial
release of a recombinant form of the enzyme glucocerebrosidase produced in carrot cells, the first plant biotechnology-derived
biopharmaceutical in the world approved for the market. Commercial momentum is gathering pace with additional candidates now undergoing
or awaiting approval for phase III clinical trials. Filling the product pipeline is vital to establish commercial sustainability, and
the selection of appropriate target products for Molecular Pharming will be a critical factor. An interesting feature of the four stories outlined
above is that they span the use of very different platform technologies addressing different types of molecules which aim to satisfy
distinct market demands. In each case, Molecular Pharming was an economically and technically suitable approach, but this decisionmaking
process is not necessarily straightforward. Although the various technologies available to Molecular Pharming are broad ranging
and flexible, competing technologies are better established, so there needs to be a compelling reason to move into plants. It is most unlikely
that plant biotechnology will be the answer for the whole biologics field. In this article, we discuss the current plant biotechnology
approaches that appear to hold the greatest promise and in doing so attempt to define the product areas that are most likely to benefit from
different Molecular Pharming technologies.
