Regulatory Strategies for the Analytical Development of New Biological Entities and Biosimilars

The webinar will focus on the relationship between analytics of biotherapeutic products and the interpretation of data to build and support a solid regulatory Chemistry, Manufacturing and Control (CMC) strategy. The importance of data interpretation is illustrated in the development of biosimilars and new biological entities, as well as in regulatory specifications regarding biotherapeutic products. 

The successful development of a biosimilar requires an upfront investment into its manufacture to match the molecular attributes of the originator and establish in vitro biosimilarity. The broad definition of the similarity concept in regulatory guidelines does not directly prescribe a path for this task. Despite this uncertainty, several manufacturers have been successful and numerous follow-on biologics are approved in the US and EU as of today. An analysis of recently approved US biosimilar products with respect to the chosen analytical similarity or comparability approach will be presented in this webinar to highlight the various quality parameters investigated for an effective follow-on strategy. The biosimilarity analysis is enabled with a precise selection of the reference material to allow for an exact definition of the design space for the various quality attributes. This overview is complemented with analytical examples from functional assays and glycan structure analysis to illustrate the significance of data interpretation in support of the regulatory dossier.

In the context of new biological entities, presented case studies will illuminate examples with respect to oxidation and acidic variant formation. The examples focus once more on the importance of understanding the data and analyzing similarity by interpreting differences within the molecular context utilizing prior knowledge.

Third and last, common specifications for biotherapeutic products will be presented. This discussion will include common push back and observations from North American and European regulators. Further case studies will be presented to illustrate strategies used to successfully avoid common regulatory traps.

In summary, a strong analytical portfolio paired with prior knowledge is essential for the development of a comprehensive analytical strategy for biotherapeutics. When it comes to the interpretation of data, a careful assessment of the differences utilizing prior knowledge is essential.

Speaker

Thomas Linnemann, PhD, Head of Regulatory CMC Customer Solutions, Solvias

Dr. Thomas Linnemann completed his PhD thesis in biochemistry at the Max Planck Institute of Molecular Physiology in Germany. He was a post-doc at the Howard Hughes Medical Institute at the University of California, San Francisco before moving to the biotech industry. He developed strategies to identify novel protein therapeutics at FivePrime Therapeutics, CA and contributed to biologics development at Novartis in the technical analytical function and in Regulatory CMC before joining Solvias.

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