Contract development
TBD photo archives. Chemists working on site in TBD laboratory.

Service overview

Early Phase API Development

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.

Have a project in mind? Let’s discuss!