Analytical Approaches to Biophysical Characterization in a Regulatory Environment

Understanding the biophysical behaviour of a biologic drug drives insight into the critical quality attributes associated with high order structure. In this article, our expert Anshuman Shukla describes the need for biophysical analysis, and the regulatory context behind the choice of analytical approaches. This includes a case study focusing on the biophysical characterization of tocilizumab which has been granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) to treat COVID-19 pneumonia. As with all biologics, studies focused on understanding quality attributes such as aggregates, potency, or charge variants or the levels of process-related impurities are critical throughout the development and commercialisation phases.

Meet our expert
Anshuman Shukla is Intertek’s Biophysical Expert and is located at the Intertek Pharmaceutical Services GLP/GCP/GMP laboratory and centre of excellence for biologics characterisation in Manchester, UK

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