BioLife files DMF for preservation media in US
HypoThermosol is designed to prepare and preserve cells, tissues and organs for low temperature (2o-10oC) environments and short-term cold storage or transportation. It reduces free radical accumulation in cells undergoing prolonged preservation, which helps reduce the level of post-storage necrosis and apoptosis.
Last month, a biotechnology company developing cellular therapies for patients with diabetes, adopted HypoThermosol for preserving, transporting, and storing pancreatic source material. The company, MicroIslet, plans to isolate and encapsulate islet cells for the treatment of Type 1 diabetic patients and is gearing up to file for approval to start clinical trials in the USA.
The application to the US Food and Drug Administration 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.
This is the second DMF application for a BioLife preservation media. In May the company filed a master file for its CryoStor cryopreservation media product platform.
Market research by TriMark predicts that the stem cell products and services sector will be worth around $104bn by 2012. Meanwhile, a similar survey by PA Consulting estimates that the worldwide market for cell preservation media alone will grow from $200m last year to nearly $350m by 2011.
BioLife chairman and CEO 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 excipients 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.
Rice added that the FDA Master File is expected to drive even stronger product adoption by shortening the qualification process for customers.
