Structural comparability of a Biosimilar to its Reference Medicinal Product (RMP) is the cornerstone of Biosimilar drug development. It is vital, from the outset, to develop a comprehensive approach to the structural analysis of both the RMP and Biosimilar. This allows the target product profile to be ascertained, against which the structure of the Biosimilar can be measured and assessed. The ICH Q6B guidelines have been adopted by regulatory agencies around the world as the recognized comprehensive approach to structural analyses.
This webinar will describe the analytical requirements of the regulatory agencies for Biosimilar structural analyses as defined in, but not limited to, ICH Q6B. There will be a focus on analytical approaches within specific areas of ICH Q6B and the regulatory expectations for each of the points. The areas covered will include:
- Amino acid sequencing
- Aggregation studies
- Terminal amino acids
- Peptide mapping and Post-Translational Modifications
- Glycosylation analysis
- Molecular weight
- Isoform pattern
- Spectroscopic profiles
The information provided in this webinar will allow scientists to address the detailed requirements of Biosimilar comparative studies and gain an understanding of the detailed structural requirements entailed in assessing Biosimilarity.
Register for this webinar now and join Dr. Richard Easton, Technical Director of Structural Analysis at BioPharmaSpec, as he shares his expertise in the area of comparability structural analysis.
Dr Richard Easton,
Technical Director - Structural Analysis
Richard obtained his PhD in glycoprotein structural characterization using mass spectrometry from Imperial College of Science, Technology and Medicine. He subsequently spent several years there as a postdoctoral research scientist working in the field of glycoprotein structural characterization with emphasis on glycan elucidation. The projects he was involved in required detailed structural analysis of glycoproteins derived from animal, plant and fungal systems, very frequently expressing unusual glycosylation profiles.
He moved to GlaxoSmithKline for a short time where he was head of mass spectrometry for the toxicoproteomics and safety assessment group. Richard joined M-Scan Limited (now part of SGS Life Sciences) in 2003 as a biochemist and became the Team Leader for Carbohydrate Analysis before being appointed Principal Scientist.
In 2016, Richard joined BioPharmaSpec as Technical Director for Structural Analysis and is responsible for the management of all aspects of carbohydrate and glycoprotein characterization at the primary structure level.
- How to develop a Biosimilar comparability approach
- How the ICH Q6B guideline applies to Biosimilar comparability
- Understand the key analytical approaches within Biosimilar comparability studies
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