Cell X and Colonyze Platform for Cell Sourcing and Process Controls
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.