Clinical upscale of Recombinant Production
Octapharma’s Clinical Upscale R&D and Production unit manages the production of material for the clinical development of recombinant products, from pilot study phases to a commercial scale.
Activities currently are focused on bringing Octapharma’s second recombinant product, the G-CSF from a human cell line, to clinical development. After successfully up-scaling to pilot plant and producing recombinant Factor VIII for toxicology studies, the group is now preparing to produce HES-G-CSF for soon-to-begin Phase I clinical studies and up-scaling to production of clinical samples under GMP conditions.
Preclinical research of further recombinant human proteins is also in early development stages.
The unit is integrated within the Biopharmaceuticals GmbH facility in Heidelberg.