Is your Biosimilar, Similar?

In this live webinar, Rakesh (USP) and Bretton (Waters) bring together regulatory insight and practical analytical expertise to explore strategies to assess critical quality attributes (CQAs).

Rakesh will focus on the analysis of comparative analytical assessment studies from successful regulatory filings of mAb biosimilars in the U.S. and EU, which identified the most common CQAs and analytical methods included in comparative studies and highlight increased adoption of more specific and efficient "analytical methods."

Biosimilarity assessment requires an extensive set of analytical tools that directly address the biophysical characterization parameters emphasized in the latest U.S. FDA biosimilar guidance and ICH Q6B . Size exclusion chromatography combined with multi-angle light scattering (SEC-MALS) has emerged as a critical technique for defining molecular weight, aggregation, impurity profiles, and related quality characteristics that support regulatory decision-making processes.

Bretton will explain how SEC-MALS can be used to measure these characteristics for biosimilars and other biological modalities.

Presenter: Rakesh Aithal, Ph.D. (Team Lead, Senior Scientist I, Pipeline Development, Global Biologics, United States Pharmacopeia)

Rakesh Aithal is currently working as a Team Lead, Senior Scientist I in the Pipeline Development Team of Global Biologics at USP. In this role, he works closely with scientific experts and stakeholders to develop physical and documentary standards used to support development and quality assessment of biopharmaceuticals with a major focus on protein therapeutics including monoclonal antibodies and antibody conjugates. He did his Ph.D. in Biomolecular Chemistry from Masaryk University and worked as a post-doctoral researcher in Cancer Research Center Marseille on the mechanistic understanding of meiotic recombination before transitioning into the biopharmaceutical industry. He has extensive expertise in a range of analytical methods for protein characterization and molecular biology techniques; and has published several research articles in peer reviewed journals. His expertise includes analytical method development, qualification, and validation along with comparative analytical similarity assessments to support biosimilar development.

Presenter: Bretton Fletcher, Ph.D. (Scientist, Waters | Wyatt Technology)

Bretton Fletcher, Ph.D. is an application scientist in the Analytical Sciences team at Waters | Wyatt Technology. He assists customers in identifying the best light scattering solutions for their analytical needs by leveraging her expertise in multi-angle light scattering. He performs feasibility studies to characterize customer samples and participates in Wyatt’s Light Scattering University. He completed his Ph.D. in Biomolecular Sciences and Engineering from the University of California, Santa Barbara.

Moderated by: Samuel Seal (Biopharma Market Development Manager, Waters Corporation)

Samuel Seal is a market development manager specializing in the biologics space. He loves LC and MS – especially on how this technology provides benefit and value.

Sam joined Waters in January of 2014 as a Sales Technical Support Specialist in the Irvine office/lab. As a TSS he performed demonstrations on various instruments, provided training for customers, often presented on technical information at varying events, and assisted with troubleshooting from Colorado to Los Angeles.

He previously worked at Pyxant Labs in Colorado Springs, CO where he gained extensive experience developing and validating methods for small/large molecules in bioanalytical assays, agricultural commodities, registration of pesticides, and worker exposure studies. He also has experience in column chromatography, sample extraction, sample clean-up, reporting and data management. Sam has hands on experience with running and maintaining various manufacturers' LC/MS/MS systems. Prior to Pyxant, Sam was a Laboratory Instructor at the University of Colorado at Colorado Springs where he earned his Bachelor of Arts in Biology and Bachelor of Arts in Chemistry.