Virtech Bio, Inc. — Department of Health and Human Services SBIR Phase I: 400

Description

This project aims to develop a human derived Hemoglobin Based Oxygen Carrier HBOC solution Phase I to be utilized in numerous ex vivo applications Phase II where an oxygen delivery solution is required machine perfusion MP systems for organ and tissue preservation MP systems for the discovery of biomarkers and perfusate in human microchips for drug discovery This is the first HBOC to be developed specifically for ex vivo applications with the novel approach being an excipient that balances for ex vivo fluid shifts Furthermore this new product will be developed within a streamlined highly efficient commercial process that will allow a seamless transition to cost effective Contract Manufacturing Organizations CMO VirTech Bioandapos s HBOC and manufacturing process were conceived following successful proof of concept ex vivo studies with an HBOC Hemopure Unfortunately the company OPK Biotech went bankrupt in Hemopure had a complex and expensive manufacturing process that precluded the use of any CMO The main issues were related to bovine contamination hydrogen gas toxicity and the need for expensive and specialized equipment VirTech Bioandapos sandapos s new process developed for this SBIR Phase I proposal addresses all these concerns while creating a more cost effective commercial production of this component The initial source of human hemoglobin molecules will be expired human blood obtained through a process already approved by regulatory bodies The outdated human red blood cells will be `washedandapos via ultrafiltration lysed by osmotic shock and purified by a three step tangential flow filtration system to remove cellular impurities Subsequently polymerization will be with glutaraldehyde followed by Schiff base stabilization The Specific aims include biophysical characterization to demonstrate similarity with the original HBOC stability testing of the molecular weight and storage parameters and compatibility testing with machine perfusion without the organs for hours at relevant conditions This product once developed and validated will be coupled with a machine perfusion device in Phase II and utilized for liver preservation according to our previous experience The new HBOC for utilization in organ preservation should have a significant positive impact in clinical transplantation Effective organ oxygenation ex vivo will enhance the current standards of organ preservation and increase the number of transplants It should have additional positive downstream effects by decreasing the morbidity and the mortality on the transplant waiting list improving post operative outcomes and decreasing the length of stay All these benefits should have a direct impact in the ability to decrease the overall costs in clinical transplantation !Project Narrative VirTech Bio is developing a human derived oxygen transport solution designed for machine perfusion MP medical devices and it will be utilized ex vivo for organ and tissue preservation Preliminary proof of concept pre clinical experiments have been performed successfully with a similar bovine derived product Anticipated benefits include enhancement of organ and tissue viability increased organ availability for transplants and improved overall transplantation outcomes