Pharma-Factory has undoubtedly advanced Plant Molecular Farming beyond the state of the art, and we have ambitious expectations that this will happen on several levels.
1. Public and governmental acceptance and acceptability
Whilst the public may appear to hold strong views on GM technologies in plants, when it comes to Plant Molecular Farming, they are generally unfamiliar or at worst agnostic about the technology, but inclined to be favourable towards GM applications that offer true medical benefits. Whilst this may appear to be a good position, a pro-active approach is the most likely to result in the most favourable outcomes. Drawing together industry and academic stakeholders, we introduced and explained Plant Molecular Farming to a range of end users across European regions, identifying barriers to acceptance and developing new novel approaches to lowering these barriers.
2. Scientific and technical advance
The ambitious scientific and technical advances in the Pharma-Factory project are all focused on advancing products. This project was primarily designed to identify approaches that will result in higher yields, better quality and greater product diversity. We have optimised the yield of commercial product targets in multiple Plant Molecular Farming manufacturing platforms, including plant cell cultures, hairy root culture, algae and intact plants. Where yields could not be improved, we have found novel solutions, such as the identification of an alternative viral display platform for our rheumatoid arthritis diagnostic. We have delivered sophisticated gene editing tools for two manufacturing platforms - Brassica species and transgenic algae, and used advanced molecular biology techniques to simplify and accelerate the processes of early development for future products.
3. Product pipeline development
SMEs developing platform technologies are usually only able to develop a handful of products in their early years. Given the development timeline for new biologics and the high failure rate, successful commercialisation, even with a strong product and a viable manufacturing process is a rare event. The ambition of Pharma-Factory has been to help establish the pipeline for products, by addressing early risks in product selection and development. All of the SMEs involved in Pharma-Factory have dedicated part of their effort to the exploration of new products (or new product classes, such as glycoproteins or monoclonal antibodies).
4. Industry engagement
The pharmaceutical industry tends to take more note when technologies become validated and target products approach the market. A criticism that is often levelled at Plant Molecular Farming is the lack of engagement from major pharmaceutical companies. So, the ambition of Pharma-Factory is to elevate the developmental status of multiple European SMEs and to help establish a wave of Plant Molecular Farming products alongside transparent regulatory pathways and positive public opinion. Together, this will make a forceful statement about the viability and future of Plant Molecular Farming, which major industrial players will not be able to ignore. In recent years, major investments by Pfizer, Mitsubishi Tanabe Pharma Corporation, Denka Seiken Co. Ltd, the Osvaldo Cruz Foundation, Glaxo SmithKline and others have helped in this endeavour.
