Pharma-Planta and Future-Pharma: Production of Clinical-grade API in Tobacco

In the Pharma-Planta EU framework 6 and Future-Pharma EU framework 7 integrated projects, the primary aim was to move plant-based expression systems for biopharmaceuticals manufacturing beyond a proof-of-concept status by developing a production process for a plant-derived biopharmaceutical, produce GMP-compliant material and test it for safety in humans in a clinical phase I study.

Fraunhofer IME did coordinate this project and contributed substantial scientific input such as the cell line and process development and the GMP-production of the HIV-neutralizing antibody 2G12 in Nicotiana tabacum.

The department for Integrated Production Platforms’ final task in the scope of this project was to provide the clinical grade API.  A production process was developed and in 2008 our efforts of designing a scalable industrial process for the production of a recombinant full-size antibody in Nicotiana tabacum cv SR-1 culminated in 4 “Engineering batches”. In 2009, having installed a fully qualified pilot scale (400 kg leaves per day) extraction plant, we obtained an extension of the GMP manufacturing authorization and produced a clinical batch of the monoclonal antibody.

With these results, Fraunhofer IME boasts to be a prime choice for cooperation partners around the world for the production of clinical-grade API from plants.