- 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.
Doug Marshall, Product Manager for Chirascan at Applied Photophysics