Assessment of Biosimilarity: Analytical Strategies to Satisfy Regulatory Requirements




April 21, 2016

 

Sponsored by
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Webinar Description:

The development pathway of a biosimilar is unlike that of a novel biotherapeutic, requiring earlier extensive analytical characterization. This hour-long webinar will provide a look at the multiple stages of biosimilar development prior to the clinic, including an update on the regulatory landscape in the US providing some insights into recent submissions.

  • Regulatory Requirements
    • Establishing the Quality Target Product Profile (QTTP) and side-by-side comparative data for the biosimilar vs originator with a focus on the FDA tiered approach
  • Analytical validation strategies
    • Strategies to develop, qualify, and/or validate analytical methods for the biosimilarity exercise
  • Structural Characterization
    • Examples of analytical methods and their application for the fingerprinting and tiered approach concept.

Learning Objectives:

  • Update on latest Biosimilar regulations in the US
  • Best practices for method validation/fit-for-purpose definition in a similarity study
  • Most up-to-date analytical methods for the characterization of Biosimilars and their pros and cons

Speakers:

Fiona M Greer BSc (Hons) MSc PhD

Global Director, Biopharma Services Development

SGS Life Sciences

Dr. Bérangère Tissot completed her PhD in Pharmaceutical Sciences in France in 2003. After a post-doc in a clinical team working on mAbs glycosylation engineering, she joined Prof. Anne Dell’s group at Imperial College London as Senior Research Associate where she specialized in Glycomics and Glycoproteomics for 5 years. Berangere then joined the highly renowned CRO M-Scan (now SGS Life Science) in 2009 and is now the General Manager for the SGS Philadelphia facility, a cGMP facility devoted to complex biopharmaceuticals, which is the Centre of Excellence for the Characterization of Biologics for SGS Life Sciences in North America. Her group is heavily involved in the design and execution of comparability, similarity and biosimilarity studies. With her 16 years of experience in structure/function elucidation, Dr. Tissot acts as the Subject Matter Expert for the Characterization of Proteins and Glycoproteins for SGS Life Sciences.

Nadine M Ritter, PhD

President and Analytical Advisor

Global Biotech Experts, LLC

Following a Ph.D. in Protein Biochemistry from Aberdeen University, Fiona Greer joined M-Scan Ltd in 1984 to found the Biochemical Services Department. Here, she pioneered and applied developments in Mass Spectrometry for structural characterization. With over 30 years experience in the structural analysis of glycoproteins using instrumental techniques, she has published many articles on the use of mass spectrometry to fulfill regulatory characterization requirements. Since the acquisition of the M-Scan Group in 2010 by SGS, she serves as Global Director for Biopharma Services Development, SGS M-Scan.

Berangere Tissot

General Manager

SGS Life Sciences, West Chester, PA

In 2014 Dr. Ritter launched Global Biotech Experts, a global technical, regulatory and quality consultancy in the biopharmaceutical industry for product characterization, comparability, release and stability testing with expertise in standard and state-of-the-art physiochemical and functional methods of analysis. Additionally, since launching the first in-depth public training class on biotech product CMC analytical and stability issues in 2000, Nadine has been highly-sought as a public and internal trainer in CMC analytical science and laboratory compliance for biotech products. She currently serves as Chair of the Scientific Advisory Board and guest instructor for the University of Maryland Baltimore County Biotechnology Graduate Program.



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