Award details

Recombinant Pharmaceuticals from Plants for Human Health

Reference	BBS/E/J/0000A182
Principal Investigator / Supervisor	Professor George Lomonossoff
Co-Investigators / Co-Supervisors
Institution	John Innes Centre
Department	John Innes Centre Department
Funding type	Research
Value (£)	739,769
Status	Completed
Type	Institute Project
Start date	01/02/2004
End date	31/10/2011
Duration	93 months

Abstract

Plants are attractive vehicles for the expression of recombinant pharmaceutical proteins as they are inexpensive and versatile systems, amenable to rapid and economical scale-up. Public opinion in Europe is generally negative towards GM plants, which has led to the loss of many SMEs and commercial development from the Union. However, the use of GM plants for medicines and vaccines rates very highly in terms of public acceptance. With this proposal, our primary aim is to build on previous proof-of-concept studies to develop pharmaceutical products through to clinical trials. The use of GM pharmaceuticals has precedents, such as human insulin and hepatitis B vaccine, but plant-derived materials used in humans has not been formally addressed within the EU. A major outcome will be to define the regulatory requirements through a process of engagement and consultation with all relevant regulatory bodies (involved in GM plants as well as new pharmaceuticals,) in order to move through clinical trials and gain permission for the use of plant derived pharmaceuticals in practice. Monoclonal antibodies will be the first generation of molecules to be developed for Phase 1 clinical evaluation, and we include 2 neutralising antibodies each for HIV and rabies. The proposal also includes a limited range of other targets, against HIV, TB and diabetes, and for some of these, new expression strategies will need to be developed. They represent the second generation molecules which will feed the development pipeline for SMEs in Europe, beyond the lifetime of the project. In each case, plant-based systems offer a real advantage, if not the only option for production on a scale relevant to the needs for that molecule. Alongside our principle aim of development plant derived recombinant pharmaceuticals, we recognise the need to put in place comprehensive risk assessments based on health and environmental impacts, and to work with EU regulatory authorities.

Summary

unavailable

Committee	Closed Committee - Plant & Microbial Sciences (PMS)
Research Topics	Crop Science, Immunology, Industrial Biotechnology, Pharmaceuticals, Plant Science
Research Priority	X – Research Priority information not available
Research Initiative	X - not in an Initiative
Funding Scheme	X – not Funded via a specific Funding Scheme

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