EPSO working groups
Molecular Farming WoGr
The goal of this latest EPSO working group is to promote research, development and innovation in the field of molecular farming - particularly translational research to increase the impact of molecular farming and plant-derived pharmaceutical proteins in the clinic by encouraging industry participation and the funding of infrastructure development and clinical development beyond phase I trials.
The group has three main tasks:
1. To develop strategies that increase the impact of molecular farming research in the EU, particularly by providing input for topics and themes developed under Framework 7, Horizon 2020 and associated funding schemes
2. To develop strategies that increase the top-loading of research funding in molecular farming, particularly the funding of applied and translational research, long-term infrastructure development programs (e.g. GMP capacity building and clinical networks), technology transfer and funding models involving public/private partnerships
3. To develop strategies that draw greater industry and clinic participation in the translational aspects of molecular farming, i.e. not only basic research but as well, process development, technology platform adoption and the creation of product pipelines based on molecular farming platforms and its use in translational research
The focus of the Molecular Farming Working Group is to increase awareness at the EU level to support research and innovation in the molecular farming sector, particularly applied and translational research and clinical development, through increased public funding of clinical research and large-scale infrastructure projects, and increased support for collaborative research between academic partners in the field and the pharmaceutical/contract manufacturing industries as agricultural and industrial uses.
Rainer Fischer, Fraunhofer Aachen, DE
Why molecular farming?
Molecular farming is the use of plants or plant cells to produce high-value products from proteins and metabolites, particularly for pharmaceutical and medical/diagnostic, agricultural and industrial uses.
Traditional production systems based on microbes are limited in scope because large complex glycoproteins cannot be synthesized efficiently - while systems based on mammalian cells (or transgenic animals) are expensive, limited in scale and come with associated risks such as the potential to harbor viruses.
In contrast, plants provide an inexpensive and convenient system for the large-scale production of valuable recombinant proteins without compromising product quality or safety. Plant seeds and fruits also provide naturally sterile packaging for valuable proteins and guarantee an extended storage life. Plants do not support the replication of mammalian viruses and no plant pathogens are known to infect humans.
The benefits of molecular farming have been demonstrated over the last 15 years through the sustained efforts of a growing number of European research groups, many of which have participated in the COST action “Molecular farming: plants as a production platform for high value proteins” as well as the EU projects Pharma-Planta, CoMoFarm and SmartCell.
[read more] During this time, several first-generation non-pharmaceutical products launched into established market sectors have been commercially successful (e.g. technical reagents for research, veterinary products). A number of plant-derived biopharmaceutical proteins for human use are on the brink of market authorization, including antibodies, vaccines, human blood products, hormones and growth regulators.
There are several potential development routes for molecular farming, but it is important to realize that the last obstacle to commercial development has now fallen with the acceptance of a manufacturing process based on plants by the European regulatory authorities allowing plant-derived pharmaceuticals to be produced in accordance with good manufacturing practice (GMP). The pipeline is now filling with product candidates and only industry inertia is preventing full-scale adoption, which suggests the technology platform will mature and become fully competitive by 2025 or later.
This will create new opportunities for European agriculture and related sectors as the plants used for molecular farming become the new high-value crops. The commercial success of molecular farming depends on technology, economics and public acceptance, in turn requiring a science-based regulatory system separated from political interference. The most significant driver of the new sector is the expected reduction in production costs, which will have significant knock-on effects on the overall biopharmaceutical market, and little market resistance is expected. At present, European politicians and the public seem unwilling to accept biotechnology-derived foods, but biopharmaceuticals are more likely to meet with approval. The enforcement of strict regulatory measures will help with this, but the fact that molecular farming is not intended for crops destined for the food and feed chain is probably the biggest factor.
Although still in its infancy, the molecular farming sector has already enjoyed considerable growth and has attracted a large amount of investment. At present, it comprises approximately 100 small companies, each focusing on the development of a few products. In some cases, there are already productive collaborations with pharmaceutical companies, such as the agreement between Meristem Therapeutics and Solvay Pharmaceuticals to develop plant-derived human gastric lipase, and between Protalix Biotherapeutics and Pfizer to develop plant-derived glucocerebrosidase, the product that is closest to market.