Recently, Biological Industries (BI) submitted a Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for purposes of moving its NutriStem® hPSC XF Medium toward being certified for clinical applications. The product is a defined, xeno-free (XF), serum-free (SF) medium that supports the growth and expansion of human induced pluripotent stem (iPS) and embryonic stem cells (ESCs).
A DMF is prepared by a pharmaceutical manufacturer and submitted to the regulatory authority in markets where the product is sold. While there is no regulatory requirement for DMFs, the document provides regulators with confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of the products.
For regulatory purposes, NutriStem® hPSC XF Medium is classified as an “Ancillary Material”, which means it is a material used in the process, but is not part of, the final product. In accordance with the four-tier USP Risk classification system, the medium is characterized as low-risk if produced in compliance with GMP’s.
Biological Industries’ submission of the DMF indicated the company’s ongoing commitment to providing cell culture clients with unparalleled innovation, quality guarantees, and regulatory assurance. In addition to guaranteeing lot-to-lot repeatability, all NutriStem® clients receive a certificate of analysis and DMF cross reference.
The product is also produced to high quality standards, quality control (QC) tested, and functionally characterized for performance in relevant cell models.
U.S. FDA Accepts Biological Industries Drug Master File (DMF) for NutriStem® hPSC XF Medium
Therefore, it is an major news that the U.S. FDA has accepted Biological Industries’ submission for its Drug Master File (DMF) for NutriStem® hPSC XF Medium, a defined, xeno-free, serum-free media for use with iPS cells and ESCs.
As stated by BI’s CEO, Alon Ariel, “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.”
A current list of the U.S. FDA’s Drug Master Files (DMFs), as well as information concerning submission of DMFs to the FDA’s Center for Drug Evaluation and Research (CDER), can be viewed at this link that is updated quarterly. As stated by the FDA, the current list contains DMFs received by September 30, 2016, for which acknowledgment letters were sent before November 11, 2016.
To learn more, click here to read the full press release from Biological Industries.