Accurately forecasting long-term stability from accelerated data
01 Sept 2026
Quality Control & Characterization
- What applications do you see for using predictive stability models or does anyone have any real-world experiences they would like to share?
- Is setting shelf-life with predictive models realistic for antibody therapeutics?
- What are the main regulatory and technical challenges to regularly implementing predictive stability into filings for antibody therapies? Have any quality attributes been particularly challenging?
- What aspects of predictive stability modeling should the biotherapeutics industry align on for consistency and to ease the regulatory burden?
- What guidelines would you expect, or want, to see for implementing predictive models?
Industry Expert
