What You Need To Know To Avoid Costly Delays In Your API Scale-Up

By Peter Pöchlauer, Principal Scientist, Small Molecules API, Thermo Fisher Scientific

If, in the course of the development process, undesirable effects occur that negatively impact API scale-up, it can prevent a company from delivering a product with reliable quality and efficacy. For these reasons, a company must be aware of any potential conditions that could occur at a small-scale that could create major issues during commercial scale-up.

Traditionally, the development of a small-scale synthesis for an active pharmaceutical ingredient (API) and its scale-up to meet the materials demand for clinical trial phases is a sequential activity that passes through multiple sets of hands. Even if the synthesis used at a small scale is the same one used at a large scale, the developer must be prepared to encounter and react to any changes to the API’s quality attributes, such as by-product profile and physical form. If, in the course of the development process, undesirable effects occur that negatively impact API scale-up, it can prevent a company from delivering a product with reliable quality and efficacy. For these reasons, a company must be aware of any potential conditions that could occur at a small-scale that could create major issues during commercial scale-up.