Jonathan Knight, VP New Product Development at Cambrex, dissects the route used to manufacture APIs, highlighting those steps that can make a process ideal.
During a drug’s clinical development, the focus is very much on producing API material — with an emphasis on speed — and the route used to manufacture the molecule is rarely altered past Phase IIa. It may be that only as the demands for product increase throughout the clinical stages, and into commercial manufacturing, that the synthetic route is scrutinised, and process chemists and engineers look to adapt it.