Cell X and Colonyze Platform for Cell Sourcing and Process Controls
Poster Feb 15, 2017
Venkata Mantripragada, Viviane Luangphakdy, George Muschler, Travis Schneider, and Brian Handerhan
Cells are the core resource for biological products & biomanufacturing. No new tissue is formed without cells. Cell populations from different donors/tissues vary highly in concentration, prevalence, & biological potential. The challenge: managing this variation in design, fabrication, & quality control of all cell therapies.
Innovators of new therapies must have control over cell sources, quality, & biological attributes of cells entering/leaving the processing chain.
The cell sourcing and product quality mantra:
- Know what you have.
- Pick what you want.
- Show what you’ve done.
- Know how to do it again.
Quantitative metrics must be used to define critical quality attributes (CQAs) of cell sources and cell products.