Quality Session
Chairs: Jerry Cacia (Genentech), Bob Kiss (Genentech) and Yuan Xu (Gilead)
The ability to deliver consistent, high-quality product is a critical challenge in the development and manufacture of complex biopharmaceutical products. As such, science and technology efforts to better understand what quality attributes are most critical to product performance in patients, and how to more effectively manage and control these attributes throughout the product lifecycle are of great interest. Potential topics of interest include: establishing attribute criticality and focusing on most product characteristics; tools and technologies for detecting and controlling post-translational modifications, impurities at the cellular or process level; how to avoid, minimize or deal with comparability challenges during product design, development, scale-up and commercialization; achieving and demonstrating biosimilarity; control strategies that move beyond traditional approaches; leveraging prior knowledge; approaches to process characterization/understanding and control that are less dependent on end-product testing; integration of in-line or at-line analytics and use in adaptive manufacturing approaches; reduction of human error through streamlined production and testing regimes.
Speakers
- Beyond Numerical Tools: Control Strategy Principles that Assure Product Quality Throughout Development- Meg Ruesch, Pfizer
- Unlocking the Power of Analytics in Support of QbD in Development- Hanne Bak, Regeneron
- Studying and controlling product quality attributes in biotheraputics- Greg Flynn, Amgen
- Understand & Control Product Quality Attributes in Cell Culture- Anli Ouyang, Lilly
- Closing the gap- Addressing similarity challenges of a biotherapeutic with the innovator product- Gargi Seth, Intas
- A Chinese Hamster Ovary Cell Host Cell Protein That Impacts PS-80 Degradation- Kelvin Lee, University of Delaware