In the Pharma-Planta EU framework 6 integrated project, the primary aim was to move the plant expression systems for biopharmaceuticals beyond proof-of-concept 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 made significant scientific 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.