Techniques for the comprehensive characterization of biopharmaceuticals

Richard Easton, BioPharmaSpec, Jersey, UK (r.easton@biopharmaspec.com)

All biopharmaceuticals require highly detailed and thorough structural characterization as part of data submitted for product approval to regulatory authorities. This is vital for determining the fidelity of the product but also for considerations of safety and efficacy. A thorough knowledge of structure gives important feedback for process control in terms of batch-to-batch consistency and also for adjustments to production processes to avoid adverse impacts on product structure and thereby maintain product quality. Regulatory authorities base their structural analytical expectations on the ICH Q6B guidelines, which will be discussed in this presentation. This document provides a detailed framework of analytical tests covering primary, secondary and tertiary structure of the molecule as well as assessment of impurities in the product. Data is strengthened through the application of orthogonal analytical techniques, something the regulatory agencies highly value.

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Short Biography of Presenting Author

Richard obtained his PhD in glycoprotein structural characterization using mass spectrometry from Imperial College of Science, Technology and Medicine, London. He subsequently spent several years there as a postdoctoral research scientist working in the field of glycoprotein structural characterization with emphasis on glycan elucidation. The projects he was involved in required detailed structural analysis of glycoproteins derived from animal, plant and fungal systems, very frequently expressing unusual glycosylation profiles. Richard joined M-Scan Limited (now part of SGS) in 2003 as a biochemist and became the Team Leader for Carbohydrate Analysis before being appointed Principal Scientist. Richard joined BioPharmaSpec in 2016 as Technical Director for Structural Analysis and is responsible for management of scientific strategy within the company.