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European Biopharmaceutical Review

Dissecting Structures

The biosimilars market is yet to fully come to fruition, and the race is still on to obtain approval for a number of products within the European market. The EMA guidelines recommend the application of state-of-the-art characterisation studies to demonstrate that the structural and physico-chemical attributes of a biosimilar are comparable to the reference medicinal product (RMP). The higher order structure (HOS) aspects of the EMA biosimilar guidelines and the ICH Q6B guidelines are discussed below, including examples of the required analyses, detail regarding which analyses should be performed when and also how the data can assist in defining biosimilarity.Questions often arise as to which analytics should be performed within a biophysical characterisation study, when these tests should be performed and what the results will tell you about your product.

Thought Processes

Characterisation of a biopharmaceutical comprises a broader set of assessments when compared to release tests. In early development stages, all possible investigations are used to provide data that will allow an initial understanding of both the RMP and biosimilar. The information gained from these fundamental tests determines the analyses that will provide useful information as development proceeds. The tests for product release are a subset of these characterisation assays, chosen based on the data, critical quality attributes (CQAs) for the product, and any issues observed during product development such as propensity to unfold would require a secondary or tertiary structure-based release test.

Data from biological assays should be used in conjunction with analytical data to determine the product CQAs.

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Dr Mark I Millichip is the Technical Director of Physico-Chemical Analysis at BioPharmaSpec and is responsible for managing all aspects of secondary and tertiary structural protein characterisation and aggregation profiles, as well as protein purification. He has worked in the field of biochemistry for 25 years in both academia and industry.

Dr Andrew J Reason is the founder, Chief Executive Officer and Managing Director of BioPharmaSpec. He has 25 years of experience in analysis of 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 is also a visiting professor at the University of Warwick, UK, and has contributed to many industry publications and is a regular presenter at conferences.

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Dr Mark I Millichip
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Dr Andrew J Reason
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