BioLife Solutions Completes Safety Studies on HypoThermosol® and CryoStor™
News Dec 17, 2008
BioLife Solutions, Inc. has 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.