Saturday 30th September 2017 - Thursday 31st May 2018
Biophysical and Physicochemical Techniques for Comprehensive Characterization of Aggregation Profiles and Secondary and Tertiary Structure
Changes to the higher order structure of your biopharmaceutical can have detrimental effects on the safety, stability, function and immunogenicity of the product. In the development of a biosimilar, it is a regulatory requirement to conduct a comparative higher order structure study with the innovator in order to demonstrate biosimilarity. Assessing higher order structure throughout product development will help ensure that any process changes (e.g. to the media, pH, purification, or formulation) have not negatively impacted the aggregation profile or the secondary and tertiary structure of the product.
This webinar will detail the key analytical techniques used to assess the higher order structure of biopharmaceuticals and therefore define potential Critical Quality Attributes (CQAs).
Case studies from representative antibody products will include example data from:
- Circular Dichroism (CD)
- Fourier Transform Infrared Spectroscopy (FT-IR)
- Nuclear Magnetic Resonance (NMR)
- Sedimentation Velocity Analytical UltraCentrifugation (SV-AUC)
- Size Exclusion Chromatography- Multi-Angle Light Scattering (SEC-MALS)
Using the information presented in this webinar, you can plan comprehensive and regulatory compliant higher order structure characterization strategies to support formulation and process development, biosimilar comparability and stability studies for your biopharmaceutical.
Watch this webinar now and join BioPharmaSpec experts, as we share our experiences and expertise in the biophysical and physicochemical characterization of proteins.