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Workshop IV: Emerging Trends in Compatibility and In-Use Stability Studies & Closing Remarks
Date
January 22, 2024
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Session Speakers:
In-Use Compatibility Testing of Cell and Gene Therapies (CGT)
Philip Grossen, F. Hoffmann-La Roche Ltd.
Abbygail Foster, Genentech, a Member of the Roche Group
Challenges of In-Use of Low – Dose High Potent Product- Case Studies and Potential Mitigations
Basma Ibrahim, AbbVie Inc.
Additional Panelists:
Andrew Chang, Novo Nordisk Inc.
Martin Nemec, Health Canada
Jennifer Swisher, CDER, FDA
Session Chairs
Speakers
General
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CASSS Welcome and CMC Strategy Forum 2024 Introductory Comments
Health care providers and patients are frequently required to manipulate biological drugs prior and during administration…
Workshop I: Established Best Practices for In-Use Stability Study Design and Testing
HOW TO DESIGN AND PERFORM IN-USE STABILITY AND COMPATIBILITY STUDIES?
Workshop II: Process
INCORPORATION OF PLATFORM BASED APPROACHES AND PRIOR KNOWLEDGE LEVERAGING INTO THE RECENTLY REVISED ICH Q5A (R2) GUIDELINE
CASSS Welcome and CMC Strategy Forum 2024 Introductory Comments
Platform technologies are used extensively across the biopharmaceutical industry to develop drugs efficiently and effectively. The application of prior knowledge and platforms from established products lays a strong foundation to guide development and advance new medicines to the patients…
