Science & Risk Based Stability Practices in Pharmaceutical Development: Part II
Science & Risk Based Stability Practices in Pharmaceutical Development Part II: Application of Science and Risk-based Predictive Stability to Biological Therapeutics
Thu, Feb 10, 2022 11:00 AM - 12:00 PM EST
Presented by the Science & Risk Based Stability Working Group
Sponsored by the Analytical Leadership Group
- Andrew Lennard, Amgen
- Lori McCaig, Seagen
- Kayla Woodlief, Biogen
This Webinar focuses on the application of Science and Risk-based Predictive Stability (RBPS) to therapeutic proteins such as monoclonal antibodies. The impact of thermal stress on protein structure and the rate of post translational modification reactions, means that SRBPS methodologies used for small chemical entities may not be immediately applicable to biological therapeutics.
Two approaches to RBPS are being developed for use in biologic stability data evaluation: (1) Prior knowledge from product development and from justified 'like-molecules' to infer the product stability profile through shelf-life and (2) kinetic modelling using empirical methodologies and accelerated condition stability data to predict the stability profile.
The use of Bayesian statistics in applying prior knowledge would be discussed as will the dependence on the analytical methods employed and the need for ongoing verification of the selected model.
Stability data has many touchpoints through product development and the application of science driven RBPS tools from candidate molecule selection, quality attribute understanding, analytical comparability to commercial product shelf-life and post-approval changes will be discussed.
Looking to the future, developments in the use of AI deep learning to evaluate stability data structured in data lakes and automation in submission of real-time stability data to agencies using cloud-based portals would be outlined.
This webinar is open to the general public. Membership in the IQ Consortium is not required for registration.