BioLife Solutions Inc (BLFS)

[techisbest]

CryoStor® Cell Freeze Media and evo® Smart Shipper Embedded in Trials Using Treg Cells for Diabetes, Lupus, Pemphigus, and Organ Transplantation

BOTHELL, Wash. and ALBUQUERQUE, N.M., Oct. 31, 2017 /PRNewswire/ -- BioLife Solutions, Inc. (BLFS), the leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and SAVSU, the leading developer of smart, precision shipping containers and cloud-based cold chain management SaaS solutions, today announced both companies are providing their respective enhanced cold chain technologies for use in 8 active and pending clinical trials conducted by the Diabetes Center and Department of Surgery at the University of California, San Francisco.


Qizhi Tang, PhD, the director of the Transplantation Research Laboratory, described a way to preferentially grow human Tregs in a clinical laboratory that are specifically targeted to protect donor tissue. These donor-targeted Tregs have been administered to liver and kidney transplant patients in phase I clinical trials under IND. Tang stated that "the hope is that, using this novel treatment strategy, we could minimize or entirely spare patients from lifelong immunosuppressive treatments and their side effects."

Jeffrey Bluestone, PhD, the A.W. and Mary Margaret Clausen Distinguished Professor of Metabolism and Endocrinology and Director of the Hormone Research Institute in the Diabetes Center, commented, "Tregs hold great promise as treatments for autoimmune diseases such as diabetes, rheumatoid arthritis and lupus, and even as therapies for cardiovascular disease, neurological diseases and obesity. Effective cold chain management is an important potential component for commercial distribution of these novel cell-based therapies if approved."

Amy Putnam, manufacturing supervisor and research specialist also responsible for biopreservation protocol design and implementation in the Bluestone and Sean N. Parker Autoimmune Research Laboratory in the Diabetes Center at UCSF, remarked, "CryoStor enables long-term storage and improved post-preservation viability of our intermediate starting materials for our cell therapy products and its quality profile supports our use in numerous human clinical trials. We also completed a rigorous validation of the evo Smart Shipper to enable better temperature regulation and logistics visibility of our high-value shipments of source material and manufactured cell products."

Mike Rice, BioLife President & CEO, commented, "We are very pleased to support the Diabetes Center and the Department of Surgery at UCSF by supplying CryoStor and providing scientific support. Over the last several years, Amy Putnam and her colleagues completed an extensive evaluation and validation of CryoStor for long term storage of mechanistic samples and intermediate starting materials. We look forward to continued collaboration and potential regulatory approval of these Treg cellular therapies, for the benefit of millions of patients suffering from various autoimmune disorders or toxicity of immunosuppression after receiving organ transplants."

Bruce McCormick, President of SAVSU, stated, "We are honored that the Diabetes Center and the Department of Surgery at UCSF have selected our evo Smart Shipper technologies. We specifically designed the evo Smart Shipper to improve cold chain logistics and transport survival of small payload cellular therapies such as Tregs."

https://finance.yahoo.com/news/biolife-solutions-savsu-providing-enhanced-103000946.html