By Anil Kane, Executive Director, Global Head of Formulation Sciences Pharmaceutical Development Services, and Andreas Stolle, Vice President of API Process Development Services, Stephen Closs, Senior Director, Global Technical Operations
If formulation problems surface late in the process of turning active pharmaceutical ingredients (APIs) into beneficial drug products, developers may have to go back and change their API production processes. In the worst cases, Phase 1 and Phase 2 trials may have to be redone. And due to the increasing complexity of today’s API molecules, formulation problems are arising with greater frequency, delaying development, and burdening developers with unanticipated and heavy costs.