GBI Biomanufacturing Selected to Take OxyBridge™ to Clinical Scale

VirTech Bio has selected GBI Biomanufacturing of Plantation, Florida, as the contract development and manufacturing organization (CDMO) for OxyBridge™, its hemoglobin-based oxygen carrier for hemorrhagic shock. The work is funded through VirTech Bio’s contract with the Medical Technology Enterprise Consortium (MTEC), which has supported OxyBridge™ development since 2019.

Chief Scientific Officer Dr. W. Richard Light, the inventor of OxyBridge™, has led development of the product and manufacturing process at VirTech Bio’s own laboratory in Massachusetts. He is leading the transfer of the process to GBI. William Light, CMC and Analytical Manager, led development of the analytical methods that clinical manufacturing requires: the tests that confirm each batch is what it should be. He is leading the transfer of those methods to GBI.

Cipher GMP, led by Dr. Thomas Page, completes the team. Cipher has been contracted to augment the technology transfer between VirTech Bio and GBI: the work of moving a process from the people who developed it to the people who will run it at scale, so that nothing is lost in between.

GBI will take the OxyBridge™ process from development scale to the clinical-grade production needed for a first-in-human trial. The first phase of manufacturing development established what the process requires. GBI’s role is to build it at scale, under the current good manufacturing practice (cGMP) standards that a clinical product demands.

Manufacturing is where hemoglobin-based oxygen carriers have historically failed due to the complexity of their manufacturing processes. OxyBridge™ was designed for manufacturability. The process uses standard reagents and equipment that permit manufacture by a CDMO, eliminating the requirement for expensive, purpose-built facilities. Prior efforts by other companies involved building and maintaining very expensive manufacturing facilities and that expense contributed to the failures of those companies, which largely ran out of money before completing clinical trials.

Producing a large, stable polymer of human hemoglobin consistently, at scale and to clinical standards, is what turns a promising molecule into a viable product that can be fully tested in clinical trials. VirTech Bio has assembled the team and expertise to meet that challenge.