Method Development: Managing a Diverse Range of APIs

Case study
Method development

CDMOs take on material at many different stages of development, and the design of analytic methods must account for the starting conditions in each unique case. In this example, Cambrex adopted a drug substance that lacked available data from previous analytical studies or synthesis. Despite these barriers, they set out to develop analytical methods to support pre-clinical and future GMP production under tight timelines.

Because there was little known about the compound, the team designed methods to assess the starting material, intermediate material and API purity. Screening methods included pH, mobile phases, columns, gradients, and column temperature. Mass spectrometry was used to understand impurity formation so that it could be controlled in the API and starting materials.

IN this case study, we discuss how Cambrex carefully designed methods for this API to be suitable and phase appropriate for future GMP use.