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European Biopharmaceutical Review

Mass Spectrometric Analysis of Process-Related Impurities

The production process of any biological drug requires the use of a wide range of chemicals, such as nutrient media, initiators of protein production, selection processes (eg, antibiotics), and chemicals used in the subsequent purification processes. Furthermore, any chemical modifications to the naturally produced biologic, such as PEGylation, will result in an even larger number of chemicals coming into contact with the drug product. All of these extraneous chemicals can end up in small amounts in the final product (despite the significant purification strategies applied during downstream processing) and may be capable of generating a biological response such as an immune reaction or other adverse event in a patient, therefore putting them at risk. Moreover, the product itself may be at risk from extended exposure to these chemicals, such as increased levels of oxidation or aggregation or other chemical modification. Changes to the structure of the product as a result of the action of these residual levels of chemicals can lead to decreased shelf life, increase in aggregation, or other adverse effects, ultimately resulting in a loss of efficacy.

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Dr Richard L Easton obtained his PhD in glycoprotein structural characterisation using mass spectrometry from Imperial College of Science, Technology, and Medicine, UK. He subsequently spent several years there as a postdoctoral Research Scientist, working in the field of glycoprotein structural characterisation with emphasis on glycan elucidation. Richard moved to GlaxoSmithKline for a short time where he was Head of Mass Spectrometry for the toxicoproteomics and safety assessment group. He joined M-Scan (now part of SGS Life Sciences) 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 all aspects of carbohydrate and glycoprotein characterisation at the primary structure level.

Dr Andrew J Reason is the founder, CEO, and Managing Director at BioPharmaSpec. He has 25 years of experience in analysis of both novel and biosimilar biopharmaceuticals and has been involved in the commercialisation of a number of analytical methods for characterising proteins. In addition to his scientific and managerial duties, Andrew has contributed to many industry publications and is a regular presenter at conferences. He is also currently a Visiting Professor at the University of Warwick, UK.
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Dr Richard L Easton
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Dr Andrew J Reason
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