What you need to know to avoid costly delays in your API 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. 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—even if the synthesis used at a small scale is the same one used at a large scale. If undesirable effects occur during the development process 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.