Navigation Links
BioLife Solutions Completes Safety Studies on HypoThermosol(R) and CryoStor(TM)
Date:12/16/2008

Additional Safety Data Could Drive Product Adoption in High-Growth Cell Therapy Market

BOTHELL, Wash., Dec. 16 /PRNewswire-FirstCall/ --BioLife Solutions, Inc. (OTC Bulletin Board: BLFS), a leading developer and marketer of proprietary cGMP hypothermic storage and cryopreservation media products for cells, tissues, and organs, today announced that it has completed an initial series of small animal safety studies at the Seattle-based Fred Hutchinson Cancer Research Center on its biopreservation media products, HypoThermosol and CryoStor.

The effort, titled, "A Preclinical Safety Study of Intravenous Injection of Biopreservation Solutions as a Vehicle for Cellular Products," evaluated injections of HypoThermosol, CryoStor, or control phosphate buffered saline (PBS) into healthy rodents. The study was designed to mimic human clinical applications where stem cells isolated from cord or peripheral blood are re-suspended in a carrier solution and administered intravenously to treat patients suffering from a variety of diseases and disorders including leukemia, anemia, lymphoma, myeloma, and other cancers.

The results of these studies demonstrate that infusion of HypoThermosol and CryoStor present no safety risk within the parameters of this two-stage evaluation in a rodent model. No toxic deaths were noted in either Stage 1 or 2 at infusion or in the 7 day follow-up. Stage 1 involved infusion of carrier solutions alone with no cells, while Stage 2 evaluated freshly isolated umbilical cord blood-derived stem cells re-suspended in the various carrier solutions. Blood chemistries and organ pathologies were also evaluated, with no abnormalities found.

Mike Rice, chairman and CEO of BioLife stated, "In collaborating on the study design with leading clinicians at the Fred Hutchinson Cancer Research Center, we intentionally selected injection volumes and cell concentrations that significantly exceed typical human dosage equivalents, to establish a wide safety margin for our customers involved in human clinical cell therapy product development and commercialization, where our products are used in their production processes."

Currently, biopreservation media products are considered excipient materials used in the production of biologic products, and the manufacturer of a biologic product is responsible for validating the use, safety, and efficacy of all excipient materials and the final product. This includes therapies where cells are directly introduced into patients without removing excipient materials.

Rice continued, "While our current and prospective customers are required to complete their own studies to determine the safety of using our products within their clinical applications, we feel that our independent safety data will encourage more cell therapy companies and hospital-based stem cell and bone marrow transplant centers to consider adopting our products. To date, more than 120 cell therapy organizations have ordered our enabling biopreservation products, which have been shown to extend the shelf life and improve the post-preservation viability and functional yield of biologic source material and derived cell-based products. We anticipate completing additional animal studies to compare engraftment capabilities of cells preserved in HypoThermosol and CryoStor against cells preserved in other standard laboratory preservation media formulations."

BioLife has already taken important regulatory steps by submitting and maintaining separate FDA Master Files for HypoThermosol and CryoStor, and these will be updated to include data from the safety studies. A link to request a cross reference to the master files can be found here: http://www.biolifesolutions.com/regulatory/mfrequest.htm.

About BioLife Solutions, Inc:

BioLife Solutions develops and markets patented hypothermic storage/transport and cryopreservation media products for cells, tissues, and organs. The Company's proprietary HypoThermosol(R) and CryoStor(TM) platform of biopreservation media products are marketed to academic research institutions, hospitals, and commercial companies involved in cell therapy, tissue engineering, cord blood banking, drug discovery, and toxicology testing. BioLife's cGMP products are serum-free and protein-free, fully defined, and formulated to reduce preservation-induced, delayed-onset cell damage and death. BioLife's enabling technology provides research and clinical organizations significant improvement in post-preservation cell and tissue viability and function. For more information please visit www.biolifesolutions.com.

This news release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements include any statements that relate to the intent, belief, plans or expectations of the Company or its management, or that are not a statement of historical fact. Any forward-looking statements in this news release are based on current expectations and beliefs and are subject to numerous risks and uncertainties that could cause actual results to differ materially. Some of the specific factors that could cause BioLife Solutions' actual results to differ materially are discussed in the Company's recent filings with the Securities and Exchange Commission. BioLife Solutions disclaims any obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

    Media Relations:                        Investor Relations:
    Len Hall                                Matt Clawson
    Allen & Caron Inc                       Allen & Caron Inc
    (949) 474-4300                          (949) 474-4300
    len@allencaron.com                      matt@allencaron.com


'/>"/>
SOURCE BioLife Solutions, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. BioLife Solutions Announces Exclusive CryoStor(TM) Supply Agreement With the New England Cryogenic Center, Inc.
2. BioLife Solutions Expands Scientific Advisory Board
3. BioLife Solutions CryoStor(TM) Adopted by Tissue Regeneration Therapeutics for Preservation Protocol for New, Non-Embryonic Source of Stem Cells
4. BioLife Solutions Outsourcing Manufacturing, Warehousing, and Order Fulfillment to Bioserv Corporation
5. BioLife Solutions Announces FDA Master File Acceptance for CryoStor(TM) Pre-formulated Cryopreservation Media
6. BioLife Solutions Credit Facility Increased to $9 Million
7. BioLife Solutions HypoThermosol(R) Adopted by MicroIslet for Processing Pancreatic Islet Cells to Treat Diabetes
8. BioLife Solutions Submits FDA Master File on HypoThermosol(R) Preservation and Storage Media for Cells, Tissues
9. BioLife Solutions Granted European Biopreservation Patent
10. Vital Images Releases Next Generation Enterprise-Wide Solutions Featuring Vitrea(R) 4.0 and ViTALConnect(R) 4.1
11. Haemonetics Announces New Subsidiary, Haemonetics Software Solutions
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... , Feb. 24, 2017  OncoSec Medical Incorporated ("OncoSec") ... will host a Key Opinion Leader event to highlight ... oral and poster presentation at the upcoming 2017 ASCO-SITC ... KOL event will be held in-person and via live ... / 9:00 AM PST at the Lotte New York ...
(Date:2/23/2017)... Calif. , Feb. 23, 2017  MIODx ... license for two key immunotherapy technologies from the ... technology provides a method to monitor a patient ... as PD-L1 and CTLA-4.  The second license extends ... a patient is likely to have an immune-related ...
(Date:2/23/2017)... (PRWEB) , ... February 23, ... ... Inc., announced today that in a published evaluation of multiple immunoassay-based threat ... U.S. Department of Energy Laboratory, PathSensors’ CANARY® biosensor threat detection technology was ...
(Date:2/23/2017)... 23, 2017 Aviva Systems Biology Corporation ... acquisition of GenWay Biotech Incorporated, a protein solutions ... product offering for both the research and diagnostic ... and enhance capabilities for both entities. GenWay,s 18 years ... will nicely complement ASB,s objective to become a ...
Breaking Biology Technology:
(Date:2/8/2017)... Feb. 7, 2017 Report Highlights ... 2021 from $8.3 billion in 2016 at a compound ... 2021. Report Includes - An overview of the ... trends, with data from 2015 and 2016, and projections ... Segmentation of the market on the basis of product ...
(Date:2/6/2017)... , Feb. 6, 2017 According ... security are driving border authorities to continue to ... reports there are 2143 Automated Border Control (ABC) ... currently deployed at more than 163 ports of ... 2013 to 2016 achieving a combined CAGR of ...
(Date:2/2/2017)... , Feb. 2, 2017  EyeLock LLC, a market ... new white paper " What You Should Know About ... of ensuring user authenticity is a growing concern. In ... of users. However, traditional authentication schemes such as username/password ... Biometric authentication offers an elegant solution to the ...
Breaking Biology News(10 mins):