Rules governing,medicinal products in the European Union: Basic requirements for active substances Part 6: APIs made by Cell Culture & for Clinical/Fermentation

摘要

The principles of fermentation for "classical" processes for production of small molecules and for processes using recombinant and non-recombinant organisms for production of proteins and/or polypeptides are the same, although the degree of control will differ. In general, the degree of control for biotechnologi-cal processes used to produce proteins and polypeptides is greater than that for classical fermentation processes.