Current Analytical Approaches to Biophysical Characterization in a Regulatory Environment

This webcast features: Dr. Anshuman Shukla is Intertek’s Biophysical Characterisation expert at the Center of Excellence for Biopharmaceuticals in Manchester, UK.

Structural integrity of protein based therapeutics is one of the major challenges in the biopharmaceutical industry where multiple factors such as the stability, efficacy and shelf life could be affected following minor changes in manufacturing process. This becomes critical particularly with development of more and more biosimilars where comparability to a reference product is required to ensure that the product being developed has similar structural integrity and activity. Multiple biophysical methods employing spectroscopic and calorimetric tools can be used for analyzing higher order structure (HOS). Moreover, with an increasing demand for generating as much structural information as possible for regulatory submissions a requirement for these analyses in a GMP set up is also there. This presentation details the different biophysical techniques employed by IPSM and their application and usefulness in a regulatory set up.

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