A Novel Approach for Objective, Quantifiable HOS Comparisons: a Biosimilar Case Study Utilizing Circular Dichroism

During biotherapeutic development a wide range of biophysical characterization techniques are required to support informed decisionmaking and contribute to the totality of evidence in regulatory submissions. Regulatory authorities are increasing their demand for ‘state-of-the-art’ techniques that can provide statistically-validatable data. To date, obtaining such results for higher order structure (HOS) comparisons has presented challenges in terms of data acquisition and suitability of statistical methods. This application note presents a novel, integrated approach to HOS analysis to generate an objective, quantifiable comparison of a commerciallyavailable biotherapeutic (Fab fragment) with a biosimilar currently under development.