Regulatory Role of Biophysics in Biologics CMC

Biophysics-driven understanding of higher order structures (HOS) and corresponding critical quality attributes (CQA) are imperative for drug regulation.

HOS modulates the functional repertoire of biologics which mainly comprises proteins. On the other hand, critical quality attributes (CQAs) are the physical, chemical, biological, or microbiological properties or characteristics that should be within an appropriate limit, range, or distribution to achieve the intended product quality (Source: ICH Q8 R2). CQAs typically relate to the drug component’s excipients, intermediates (materials in the process), and drug products.

In this Point of View, we discuss the role of biophysics- driven analytical tools in accurately identifying biologics CQAs and analyzing HOS – resulting in the final product being efficacious and safe for patients from a regulatory perspective.