- Understand why knowledge of a CQAs impact on HOS is as important as knowledge of its impact on function
- Learn best practice for HOS including statistical approaches and regulatory expectations
- Deepen product understanding to improve efficiency, reduce risk and make stronger regulatory filings
Are your characterization and comparability studies robust and efficient?
Higher Order Structure measurements are a regulatory requirement and more. Because of the protein structure: function paradigm, HOS measurements are complementary to function. Robust approaches on HOS support functional assays when assessing risk associated with post translational modifications.
Presented by:
Doug Marshall, Product Manager for Chirascan at Applied Photophysics