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FUTURE-PHARMA Report Summary

Project ID: 269110
Funded under: FP7-IDEAS-ERC
Country: United Kingdom

Mid-Term Report Summary - FUTURE-PHARMA (Exploiting plants for the production of future generation recombinant pharmaceuticals)

The major objective of the Future-Pharma project is to develop innovative ways to use plants for the economic, safe and sustainable production of regulator-approved combinations of active pharmaceutical ingredients based on recombinant proteins. We focus on the production of antibodies and lectins against HIV and rabies, with the aim of generating GMP-compliant microbicidal cocktails for evaluation in phase I clinical trials. Key aspects of the project include the production of medicines both individually and as combinations in individual plants, and the development of innovative technologies to simplify the regulatory process for future products, and the development of manufacturing concepts that are transferrable to developing country settings.
We have generated many transgenic tobacco lines expressing some of the most potent HIV neutralising antibodies and lectins known. We have also produced plant lines for two anti-rabies antibodies that are recommended by the WHO for rabies post-exposure prophylaxis. We are currently in the process of breeding elite plant lines that will be the starting point for drug manufacture.
In order to standardise the development of transgenic plant lines for future products, we have adopted cutting edge technologies that will enable targeted and predictable gene integration into the plant nuclear genome. This is important because at present the gene insertion process is random, which means that for every new plant line, regulatory authorities will require an individualised portfolio of data to characterise the nature of the genetic modification and its effect. If a technology can be developed that eliminates this random insertion process, this data characterising the genetic modification can be genericised, greatly simplifying the regulatory review process. This is basic research that will be ongoing for the entire duration of the project.
To simplify downstream manufacturing processes (drug extraction and purification) and to facilitate transfer of plant molecular farming technologies to developing countries, we are refining the methodologies involved. We have made progress in this regard with respect to the methods used for the initial clarification of plant extract, resulting in a cost reduction of approximately 30% compared to the previously-developed process. An extension of this approach is to investigate whether purification is needed at all, and one of the original aims was to assess whether a crude plant extract might be suitable for treatment, rather than a highly purified product. Although an attractive proposition, this does require expression of the drug candidate at very high levels, and so far we have not been able to achieve this.
Finally, we have made an early start on the work required in preparation for the clinical trial that is envisaged in the final year of the project. We are preparing to discuss the modification to the manufacturing process with national regulators.

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United Kingdom
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