KIBBUTZ BEIT HAEMEK, Israel and CROMWELL, CT, USA – November 30, 2016 – Biological Industries (“BI”) announced today that the United States Food and Drug Administration (FDA) has accepted the submission for its Drug Master File (DMF) for the company’s NutriStem® hPSC XF Medium, a chemically defined, xeno-free, serum-free media, which is designed to support the growth of human embryonic stem cells (hESCs) and induced pluripotent stem cells (iPSCs).
A Drug Master File (DMF) is a confidential detailed document submitted to the FDA by a manufacturer that includes the Chemistry, Manufacturing and Controls (CMC) information about their product. An active DMF enables clinical investigators to cross-reference the DMF in their own sponsored IND-application.
“We could not be more pleased with the acceptance of our Drug Master File,” commented Alon Ariel, CEO of BI. “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.”
NutriStem® hPSC XF Medium was developed and launched in 2009, and has been increasingly adopted by leading academic and commercial research labs worldwide for use in the culture of pluripotent stem cells.
To learn more about NutriStem® hPSC XF Medium and BI’s other products, please visit www.bioind.com or call:
- (860) 316-2702 (US)
- +972 4-996-0595 (worldwide)
About Biological Industries
Biological Industries (www.bioind.com) is one of the world’s leading and trusted suppliers to the life sciences industry, with over 30 years’ experience in cell culture media development and manufacturing. BI’s products range from classical cell culture media to supplements and reagents for stem cell research and potential cell therapy applications to serum-free media and many other products for animal cell culture and molecular biology. BI is committed to a Culture of Excellence through advanced manufacturing and quality-control systems, regulatory expertise, in-depth market knowledge, and extensive technical customer-support, training, and R&D capabilities.
Biological Industries USA (BI USA) is the US commercialization arm of BI, with facilities in Cromwell, Connecticut.
Biological Industries Israel Beit-Haemek
Alon Ariel, CEO
Biological Industries USA, Inc.
Tanya Potcova, CEO, BI-USA