The Biopreservation Company™ The Biopreservation Company™
Unisol™ Solution for Cell, Tissue and Organ Preservation: Unisol™ is a patented serum-free base solution formulation, the design of which accounts for biophysical requirements and minimal biochemical components, standardized for all potential cell preservation applications. Unisol™ can be used as a vehicle for additive cytoprotective "cocktails" optimized for the diverse biological requirements of different cell and tissue types during cold storage and for supplementation with cryoprotectants for cryopreservation. Unisol™ is produced to client specifications in vials, bottles or bags. Prices available upon request.
Islets of Langerhans for Treatment of Diabetes: Type 1 diabetes mellitus is characterized by loss of the insulin-producing beta cells of the Islets of Langerhans in the pancreas leading to insulin deficiency and vascular disease. Treatment of this form of diabetes by Islet Therapy should treat both the acute need for insulin and prevent chronic vascular disease that leads to organ failures, neuropathy, blindness and loss of limbs. We are in a pre-regulatory stage of product development in which we are finalizing preclinical methods for production of Islets that should make Islet transplantation economically viable (patents pending). It is anticipated that Islets of Langerhans manufactured from different sources will be regulated in the US as therapeutic products.
Improved Organ Preservation Solutions and Storage Products: The Company has several product concepts in research assessment for improved tissue and organ storage in collaboration with commercial and academic organizations. Our lead product in the pipeline is a recombinant insect-derived antifreeze formulation in Unisol™ Solution. Demonstration that this potential product maintains vascular tissue functions during at least 3 days of sub-zero storage, without freezing, constitutes strong demonstration of technical feasibility and efficacy. The US regulatory pathway is anticipated to be that of a device because it is a solution that is intended to be employed outside the body and not metabolized by the patient.
Cell and Tissue Cryopreservation Methods: The Company has developed new and improved patented methods for preserving adherent cells on substrates, cartilage tissues and cardiovascular tissues. Methods for preservation of cells on substrates, suitable for high throughput screening methods or tissue engineered regenerative medicine products, and cartilage tissues are available for license. Cardiovascular tissue product development for ice-free human heart valve preservation for heart valve replacement is in the preclinical safety testing phase that includes more extensive animal trials, hemocompatibility and immunogenicity studies. The US regulatory pathway for human tissues depends upon the degree of tissue manipulation involved and may follow either a device or therapeutic product pathway depending upon past product regulatory decisions or mechanism of product action in the patient.
