With recent FDA approval of biosimilars in the US emphasis on accurate and robust characterization is paramount. Regulations and guidelines (FDA and ICH) regarding what constitutes appropriate characterization include primary sequence analysis, secondary and tertiary structure analysis, and immnuohistochemical responses. This seminar highlights the current spectroscopic and biophysical methods that can be used to characterize biosimilars and biologics during the initial process development stage. These methods can also be applied to assay changes, if any, in the final drug product. This initial characterization approach can utilize both vibrational spectroscopy (FT-IR/Raman) and solution biophysical methods (AUC and SEC-MALS). During the final drug product formulation, small molecule approaches (e.g. LOD, LOQ, and Sameness Assay) can be applied to biosimilars and biologics. This approach utilizes the correlation of vibrational spectroscopy with solution based biophysical methods yielding robust quantitative/qualitative characterization of biosimilars and biologics.

Dr. Lake Paul is currently a senior scientist for the Triclinic Labs working on the development of cGMP particle size analysis methods such as laser diffraction and methods for materials characterization using FT-Raman/IR and chemometric analysis. He earned his Ph.D. in Structural Biology and Biophysics from Purdue University and has received several awards and fellowships including the Ruth L. Kirschstein National Research Service Award and the Biomedical Minority Fellowship.  After receiving his doctorate, he completed his postdoctoral training at the National Institute of Environmental Health Sciences, NIH as an Intramural Research Training Award Fellow where he studied the applications of mass spectrometry to structural biology. He then returned to Purdue University as the Director for the Biophysical Lab and Proteomics Facility where he spent more than five years successfully publishing in peer reviewed journals before accepting his current position with Triclinic Lab.