Producing clinical batches for innovative APIs shares many elements with GMP API development but diverges in key aspects. The primary aim is to manufacture a limited quantity of the novel API for early-phase human clinical trials, focusing on evaluating safety, efficacy, and tolerability.
The starting point is usually an existing lab-scale proof-of-concept technology that has undergone validation through animal or in vitro studies. This stage serves as a crucial link between preclinical research and full-scale API development, guiding future strategies based on data from human trials.
TBD is well-equipped to handle the specific needs of clinical Phase API development and offers facilities that accommodate lower pilot-scale production volumes.