Kristina Flavier, Senior Scientist, recently presented at the BEBPA 2025 Biotherapeutic Shelf-Life Determination Conference, held virtually 4–6th November.
The BioPharmaceutical Emerging Best Practices Association (BEBPA) provides a platform for scientists and industry professionals to share insights and address key challenges in biopharmaceutical R&D. The organization is dedicated to advancing innovative strategies that improve patient safety and accelerate the creation of safe, effective biopharmaceutical products.
In her presentation, “Accelerated Stability for Shelf Life of Biologics,” Kristina discussed the application of risk-based predictive stability (RBPS) methodologies such as FreeThink’s proprietary accelerated stability assessment program (ASAP) to biologics, an area where complex degradation pathways and nonlinear kinetics often challenge traditional shelf life prediction. She addressed the perception that high-temperature data may be unrepresentative of long-term refrigerated storage. By carefully considering phase behavior, she showed how an appropriate RBPS design space can successfully predict long-term shelf life from accelerated studies, illustrating new opportunities for predictive stability modeling in biologics development.
The conference agenda can be found here
For access to the slides, click here
If you have any questions, please contact Dave Lucey at david.lucey@freethinktechnologies.com