I find this really helpful in shedding light on the issues that...

I find this really helpful in shedding light on the issues that the company may be dealing with:

https://www.precisionmedicineonline.com/regulatory-news-fda-approvals/next-gen-cell-therapies-bedeviled-regulatory-murkiness-product#.ZCATG_d_WA4

Marc Better, a consultant with the cell therapy and biologics CMC consulting firm Pharmefex, also pointed to product characterization and potency assays as an area that continues to bedevil cell therapy developers. "It's extremely important to have robust tools to understand what the product's biological properties really are and to be able to use those tools to guide development," Better said, noting this is all the more important with new iterations of existing products. "Analytical methods used for product release and for expanding characterization are essential to establish relationships between primary and secondary products." Better's advice to sponsors echoes what regulators have long told companies making first-generation cell therapies: implement a potency assay strategy as early in the drug development cycle as possible.