Biological Industries receives FDA approval for NutriStem

Biological Industries' Drug Master File for NutriStem hPSC XF Medium has been accepted by the U.S. Food and Drug Administration.
NutriStem hPSC XF Medium is a media that is both xeno- and serum-free that has bee defined commercially. It was developed to aid in the growth of human embryonic stem cells and induced pluripotent stem cells.
“We could not be more pleased with the acceptance of our Drug Master File,” Biological Industries CEO Alon Ariel said. “This Drug Master File will enable our cell therapy customers to integrate NutriStem hPSC XF into their clinical trial protocols more easily. We have seen a rapid adoption of NutriStem by numerous academic and therapeutic organizations and expect it to grow further as NutriStem hPSC XF is used in more clinical trials around the world.”
DMFs are submitted to the FDA by manufacturers and include the Chemistry, Manufacturing and Controls information about their developed products. Active DMFs allow clinical investigators to cross-reference the DMF when it comes to their own sponsored IND-applications.