September 12, 2017
Author: Peter Poechlauer, Innovation Manager, Patheon
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.
Learn why 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.