Biopharmaceutical proteins are typically produced in cultivated mammalian cells, a costly process with limited scalability. Thus products such as monoclonal antibodies are very expensive and often beyond the reach of the world’s poor. The problem is compounded by the fact that important strategies for preventing diseases such as HIV and rabies typically involve large doses of multiple antibodies and other virucidal proteins. Plants have emerged as alternative production platforms for biopharmaceutical proteins because they are less expensive, more scalable and potentially could be transferred to developing countries. Recently, the first products have reached the clinic, but many of them are follow-on products already manufactured in mammalian cells.
Here, Prof Julian Ma (St George’s Hospital Medical School, London, UK) and Prof Dr Rainer Fischer (RWTH Aachen University, Germany) aim to develop innovative ways to use plants for the economical, safe and sustainable production of combinations of active pharmaceutical ingredients (APIs) based on recombinant proteins, thereby pushing the boundaries of what can be achieved in plants beyond current capabilities with fermenter-based systems.
We will focus on the production of antibodies and lectins against HIV and rabies, with the aim of generating GMP-compliant microbicidal cocktails for evaluation in human trials. Key aspects of the project will include the production of APIs both individually and as combinations in plants, the development of technologies allowing the introduction of transgenes into pre-determined genomic loci, the use of click chemistry to optimize the production and stoichiometry of recombinant protein cocktails, the development of candidate products for both topical and parenteral administration and the development of downstream processing concepts that are transferrable to developing countries, such as minimal processing and processing trains based on pre-assembled disposable modules. We will complete one Phase I clinical trials, each testing a plant-derived product that advances the field in a significant way