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 describes the analytical requirements of the regulatory agencies for Biosimilar structural analyses as defined in, but not limited to, ICH Q6B. There is a focus on analytical approaches within specific areas of ICH Q6B and the regulatory expectations for each of the points. The areas covered 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.
Join Dr. Richard Easton, Technical Director of Structural Analysis at BioPharmaSpec, as he shares his expertise in the area of comparability structural analysis.