BioLife Solutions Inc, a leading developer and marketer of proprietary hypothermic storage and cryopreservation media products for cells, tissues, and organs, announced that it has submitted a Master File to the United States Food and Drug Administration (FDA) for the company's HypoThermosol preservation media product.
An FDA Master File provides key information about the quality of components, materials and manufacturing processes involved in producing medical devices and human drugs, including related products such as media to preserve and store biologic materials like cells, tissues and organs.
In May 2008 the FDA accepted the company's submission of a Master File for its CryoStor cryopreservation media product platform.
BioLife chairman and chief executive Mike Rice remarked, "This Master File submission for HypoThermosol completes our stated corporate objective of offering the easiest to use biopreservation media products with the best regulatory footprint in the industry."
Currently, biopreservation media products are considered excipient materials (inert or inactive compounds or reagents) used in the production of biologic products, and a manufacturer of a biologic product is responsible for validating the use, safety, and efficacy of all excipient materials. An FDA Master File is therefore a key information source for end-users of BioLife products.
Rice added that the FDA Master File is expected to drive even stronger product adoption by shortening the qualification process for customers in BioLife's markets. The company plans to take further steps in raising the bar for the quality of key ancillary and excipient compounds related to the production of cell and tissue-based therapies.
Mark Sandifer, director of quality at BioLife, added, "This submittal is another step in our continuous quality improvement initiative, and it supports our goal of offering the highest quality biopreservation media products to our customers. Our team did a great job assembling the required documentation for the HypoThermosol Master File, and our scientific advisors again provided key input."
BioLife Solutions develops and markets patented hypothermic storage/transport and cryopreservation media products for cells, tissues, and organs.