Process Characterization And Validation For Biologics: The Importance Of Analytical Assays

By Vladas Algirdas Bumelis, founder and CEO, Dominic Chow, senior director of process development, and Gytis Miliauskas, head of chromatography method group, Northway Biotech

Analytical assays are an integral part of the drug development process, providing critical data to support the safety and efficacy of pharmaceuticals. While nearly every drug developer understands the importance of solid analytical capabilities in aggregate, recognizing the increased complexity of biologic analyses when compared to small molecule drugs can help companies new to the biologics space avoid unnecessary complications and prevent cost overruns.

There are a number of technologies and methods contract development and manufacturing organizations (CDMOs) employ to optimize a biologic‘s critical quality attributes. Ensuring a CDMO has the right analytical capabilities in place to deal with the increased complexity of biologic development is paramount. This vetting process hinges on a few key attributes: the experience of the CDMO, the depth and breadth of its analytical capabilities, and the degree to which its workflows are integrated across those analytical capabilities.