Newswise — Important discoveries using biologic materials in regenerative medicine, drug discovery and biobanking are subjected to hidden risk due to a simple and often overlooked problem: bad choices in transportation and storage containers. If biologic samples are cooled or frozen for storage using traditional “home-brew” liquid media—or if they are transported in foam containers whose temperatures vary too widely—the samples can be ruined before they are ever used.

Shockingly, this problem has received little attention in contrast to the painstaking work being done by lab researchers themselves. Ignoring the challenge of enhancing biopreservation and cold chain logistics has major consequences: it could compromise the effectiveness of cutting-edge immunotherapies such as CAR T-cell therapies, in which a patient’s blood, containing T-cells, is drawn in the hospital and shipped to a lab. In the lab of a regenerative medicine company, a life-saving dose is manufactured using the T cells and then shipped back to the clinic for patient infusion. Poor cold chain choices put this precious dose at great peril. If the dose can’t be used because it was subjected to a temperature excursion or arrived too late to infuse within a validated stability window, the patient doesn’t get treated and the cell therapy company’s clinical trial could fail. In a post-approval scenario, imagine an insurance company refusing to reimburse due to a lack of treatment or lack of proof that the dose was properly stored and shipped.

Mike Rice is President and Chief Executive Officer of BioLife Solutions, Inc., a leading developer, manufacturer and marketer of proprietary clinical-grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud-hosted biologistics cold chain management app for smart shippers. He can address why biotech companies and hospitals are increasingly interested in biopreservation and why “cold chain” logistics are so important. He is also an expert on why, in the realm of immunotherapy, it is important to ensure that a patient’s CAR T-cell sample remains viable between the time it is created and the time it is infused into the patient. Furthermore, he is an expert on the risks of utilizing a biologic sample that has been frozen and thawed using traditional commercial and “home-brew” media while being stored; the techniques hospitals currently use to ensure that cells and other biologic samples are viable; how new biopreservation technology makes it easier to mitigate molecular cell stress during the freeze/thaw process; how long a cell or other biologic sample can be safely stored while frozen before being thawed, thanks to new biopreservation technology; and how the “Internet of Things” plays a role in biopreservation and cold chain logistics.

BioLife recently entered into a 10-year supply agreement with Kite Pharma, a leading developer of CAR and T-cell receptor products for various cancers. The agreement provides for Kite’s supply of BioLife’s CryoStor clinical-grade freeze media for cells and tissues, which is embedded in Kite’s manufacturing process for a CAR T-cell therapy currently in four clinical studies for various cancers. Some of BioLife’s other customers include Asterias, Adaptimmune, Bellicum, Capricor, Celyad, Cook, Kite, Opexa, Sotio and TiGenix. Currently, BioLife’s preservation media products are embedded in more than 220 customer validations and clinical trials of novel cell-based therapies.

More About Mike RiceMike Rice has been President and Chief Executive Officer and a director of BioLife Solutions since August 2006, and was chairman of the board from August 2007 to November 2013. He is also the President of biologistex CCM, the Company’s joint venture with SAVSU Technologies, Inc. Mr. Rice has more than 30 years of leadership and entrepreneurial experience in the medical and high tech industries. He was most recently the senior business development manager for medical and wireless products at AMI Semiconductor, from October 2004 to August 2006. From October 2000 to October to August 2006, Mr. Rice also served as the director of marketing and business development at Cardiac Science, Inc., a manufacturer of automated external defibrillators. Prior to that, from May 1998 to October 2000, he was the Vice President, Sales and Marketing for TEGRIS Corporation, a privately held network services provider. Mr. Rice also spent 12 years, from May 1986 to May 1998 at Physio Control Corporation in several sales and marketing management roles prior to its acquisition by Medtronic Inc.