FA0804

Molecular farming

Plants as a Production Platform for High Value Proteins

This WG aims to provide a broad and global overview of the state of MF in the world today. Its primary purpose is to survey the global MF sector, identifying the main contributors, the technologies that are being used, the products that are being developed, the financial implications of these strategies, the contributions from academia and government research organizations, the involvement of SMEs and large companies, the IP framework and the juxtaposition with developing regulatory guidelines.

This broad overview will involve reciprocal interactions with the other WGs specifically in the areas of production systems and processing strategies (WG2) and target molecules (WG3) but will also incorporate marketing, commercial development, clinical trials, regulatory approval, regulation, public acceptance, stakeholder involvement (particularly farmers, patient advocacy groups and the bioprocessing industry), available research infrastructure and the impact on research funding and opportunities for research scientists involved directly or peripherally with the MF area. One of the important roles of WG1 is to assess the impact of MF on developing countries and to develop a strategy for their active engagement, so that the technology can be co-utilized with developing-country organizations to mutual benefit, avoiding the impression that new technologies are being foisted upon unwilling countries for untested and unverified products and processes. This will involve the identification of strategies to facilitate technology transfer, training, IP donation/licensing for humanitarian purposes, skills development and engagement with local farming communities, and developing county industries and educational facilities.

The initial output from WG1 will be a positional report which summarizes the global state of MF and the position of European research within that global picture. This will lead to the development of a strategic vision document whose dual purpose will be to identify areas where European research and development effort can have the most significant and positive global impact, and set out a long term strategy detailing how these aims can be achieved. This will cover the scientific areas which have most development and deployment potential, key product candidates that will be suitable for fast-track development and a description of how these areas fit in the current and emerging IP and regulatory landscape.

Ultimately, the strategic vision document will act as a guide for relevant EU bodies and scientists to find science-based information that will help to focus European efforts, reduce redundancy in research and development, identify impact areas to enhance European competitiveness and identify a dissemination strategy to maximize stakeholder awareness, public acceptance and support and regulatory support for MF in Europe and beyond.

In contrast to established host systems like E. coli or mammalian cells, the regulatory requirements for plant-based therapeutics are not yet fully defined. However, both the US Food and Drug Administration (FDA) and EMEA have recently published draft guidance documents addressing this issue. Thus the future focus of the agencies concerns and activities in the field of manufacturing of biopharmaceuticals from genetically engineered plants has become clearer. WG1 will address open questions, for example at which step the process should be transferred to a GMP environment.