SPECIAL REPORT: Current Analytical Approaches to Biophysical Characterisation in a Regulatory Environment

In association with BioProcessing International

Structural integrity of protein-based therapeutics is one of the major challenges in the biopharmaceutical industry. Multiple factors such as product stability, efficacy, and shelf life could be affected following minor changes in manufacturing process. Multiple biophysical methods employing spectroscopic and calorimetric tools can be used to analyse 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 environment is also important.

This report focuses on current biophysical analyses that provide a better understanding of a biologic drug and new analytical approaches that are key to a successful program addressing critical quality attributes to support regulatory submissions.


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