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FA0804 |
Molecular farming Plants as a Production Platform for High Value Proteins |
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| Background | Reasons | Organisation | Joint us | Mailing list | WG 1 | WG 2 | WG 3 | STSM | Meetings | Links | |
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Production systems and process development (WG2) This WG2 aims to produce a critical evaluation of all current systems for the cost-effective production of valuable recombinant proteins like pharmaceuticals in plants and plant cells. The aim is to create new and attractive options for moving from the R&D phase to the clinic and to create market opportunities for SMEs and other corporate entities interested in the field of MF. Specifically, WG2 will carry out an inventory and literature study to summarize the state-of-the-art in MF and identify major bottlenecks hindering commercial exploitation. Discussions will be initiated to define and understand the key constraints that currently prevent or limit the commercial exploitation of plant-based production of complex recombinant proteins like biopharmaceuticals. Simultaneously with these activities the WG2 will attempt to investigate the reasons for the apparent limited success of commercial activities in the field of MF in Europe. The WG2 intends to engage in discussions with SMEs and larger companies active in the field, both in the EU and elsewhere. It also intends to take advantage of other such initiatives contemplated within a number of collaborative projects. One of the most difficult challenges in the processing of plant-made pharmaceuticals is the development of suitable technologies for the early steps in downstream processing. The requirements for processing, independently whether whole plants or plant cells are in question, differ most markedly from those established in traditional fermentation-based microbial or mammalian cell systems for the production of recombinant therapeutic proteins. Furthermore, the design and engineering experience as well as process know-how are decades behind the established pharmaceutical technologies. Later process stages are product specific and less influenced by the expression platform. The evaluation for possible downstream processing system needs to consider the source of plant material and the minimum level of extraction and purification required for orally-delivered and injectable products to minimize processing costs making the technology sustainable and industrially exploitable. Additionally major steps to be analyzed include early process stages, subsequent purification steps and quality control and post-production monitoring which all may affect the final yield and quality. In consultation with WG1, regulatory requirements and the demands of the pharmaceutical industry regarding product quality will be considered as well. |
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