(705d) Models for Comparative Characterization of Complex Mixture and Biological Drug Products

Comparative characterization of drug products via different analytical techniques is often needed to support product development. This comparison can be used for the purposes of biosimilar or generic drug product development or to evaluate changes during the drug product lifecycle. These may include manufacturing process changes, and especially those initiated post-approval. Such comparisons may also help ensure therapeutic consistency while advancing through the phases of a clinical trial. For homogeneous small molecule drugs these comparisons can be relatively straight forward. However, for heterogeneous drugs such as biotechnology products or complex mixtures, this process can prove much more challenging. For these cases, mathematical models may aid in determining the degree of sufficiency of in vitro characterization needed for such comparisons. This presentation will examine such models developed via FDA collaborations to: (i) characterize multiple batches of heterogeneous drug products, (ii) examine structure, physicochemical stability, and biological activities informed by existing knowledge using a wide range of analytical technologies, and (iii) develop data visualization tools and novel mathematical algorithms to integrate the chemical, physical, and biological data to assess critical quality attributes (CQAs).