Cell therapy process development is costly, time-consuming, and constrained by limited availability of patient material. Traditional approaches like one-factor-at-a-time (OFAT) and design-of-experiment (DoE), while valuable, often demand extensive experimentation to define robust operating spaces which slows development and strains resources.
This webinar introduces an innovative fluid dynamic–guided approach to process development that reduces the number of biological experiments required without compromising the quality or robustness of the outcome. By using mixing characterization, including dye mixing, solids suspension, and particle image velocimetry, to mechanistically link rocking conditions to hydrodynamic behavior, development teams can radically narrow the experimental space before biological testing begins.
Attendees will walk away with a clear understanding of how flow regime identification, dimensionless mixing analysis, and shear characterization can be applied within a quality by design (QbD) framework to rapidly define critical process parameters and robust operating ranges for cell therapy manufacturing with automated, bellows-based CGT manufacturing platform — including key steps such as CAR-T activation and lentiviral transduction.
Key takeaways include:
- How fluid dynamics characterization supports a Quality by Design (QbD) framework to define critical process parameters and robust operating spaces
- How to identify early transitional, late transitional, and turbulent flow regimes through dimensionless mixing number analysis
- How targeted biological testing, guided by hydrodynamic insights, reduces experimental burden and accelerates process optimization
This webinar offers practical, actionable insights for teams looking to build more efficient and robust cell therapy development strategies using the IRO platform.
Speakers:
