The GMP Development Unit converts highly manual academic laboratory procedures into GMP-compliant manufacturing processes to obtain official manufacturing authorization for the production of clinical trial samples, including (semi-)automated equipment and solutions.
We also have extensive knowledge and experience in the establishment and optimization of new analytical methods (e.g. cytotoxicity or efficacy assays) and the documentation and evaluation of all manufacturing- and quality-related data under GMP-like conditions.
GMP process design, optimization & automation
Implementation and development of quality controls