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.
Basic fibroblast growth factor (bFGF) is used in neural stem cell (NSC) media to maintain multipotency. Native bFGF rapidly loses biological activity when exposed to culture conditions (37°C), Heat Stable (HS) bFGF maintains > 90% homology to the native protein and ≥ 80% biological activity, even after 72 hours of exposure to 37°C.READ MORE
For circulating cell free DNA (ccfDNA) to be used in cancer research successfully, workflow standardization is essential. Access this poster to discover tips on optimal workflow control, how to yield smaller ccfDNA fragments and the differences in quantification and qualification of ccfDNA.READ MORE