A four-organization biotech team led by San Antonio-based nonprofit BioBridge Global (BBG) won a $7.8 million contract from the Medical Technology Enterprise Consortium (MTEC), a biomedical technology association that collaborates with multiple government agencies under an agreement with the U.S. Army Medical Research and Materiel Command (USAMRMC). BBG coordinated the efforts of the U.S. Army Institute of Surgical Research (USAISR) Coagulation and Blood Research, San Antonio biotech firm StemBioSys, and Maryland-based RoosterBio Inc. in submitting the proposal and ultimately gaining funding.
The grant will support the development of large-scale manufacturing capabilities for clinical-grade stem cells which will be used for research and therapeutic purposes.
Regenerative medicine is a branch of translational research in tissue engineering and molecular biology which deals with the process of replacing, engineering, and regenerating human cells, tissues, and organs to restore or establish normal function. This novel therapeutic approach used for damaged tissues and organ systems goes beyond repairing them – tissues are completely regenerated with the use of stem cell therapies.
While human bone marrow-derived mesenchymal stem cells (hMSCs) are the most widely used type in both research and clinical settings, researchers in the growing field of regenerative medicine have difficulty getting enough of these stem cells in both the quality and quantities they need.
The consortium will use its grant to develop economical means for large-scale stem cell manufacturing to make stem cell use and related services in regenerative medicine more affordable, all the while maintaining critical quality control. The contract specifically will fund the increase of xeno-free biomanufacturing processes for stem cells, which are preferable to those using bovine-derived materials for therapeutics.
Such treatments could revolutionize medical care for soldiers injured in combat, the broader military community including dependents and retirees, as well as the civilian patient population.
Scientists identified regenerating tissue in non-healing wounds, bone fractures, devastating soft tissue injuries, and treatment of ischemic heart disease, as well as enabling technology development in fields such as 3D bioprinting as potential applications for the developing therapies.
“BioBridge Global and our collaborators were in a unique position to pursue this contract because each of us brings (to the table) critical capabilities required to develop a process for large-scale manufacturing of clinical-grade stem cells,” said Becky Cap, chief operating officer of GenCure, a BBG subsidiary that specializes in regenerative medicine. “Developing the process to scale up manufacturing will enable other research and development efforts that will result in truly translational, tangible therapeutic benefits for patients.”
The plan for the large-scale manufacturing of clinical grade stem cells includes several stages.
RoosterBio will expand its existing hMSC product platforms in several phases. BBG subsidiary GenCure will work with RoosterBio and StemBioSys to develop a novel, xeno-free nutrient source for hMSCs in culture by testing a range of source materials available at BBG and integrating technology developed by StemBioSys. USAISR Coagulation and Blood Research will develop and evaluate media components and develop assays to test the hMSCs for safety and potency.
The grant will fund three years of research, process development, and manufacturing with the goal of developing technologies for producing clinic-ready stem cells.
“RoosterBio is excited to bring our stem cell biomanufacturing technology platforms together with an amazing team of collaborators to push forward scalable regenerative medicines for both military and civilian use,” RoosterBio CEO Jon A. Rowley said. “This MTEC contract allows the opportunity for a true acceleration of the manufacturing sciences’ aspects of regenerative medicine.”
The contract may also allow StemBioSys to validate the clinical importance of one of the technologies it has been developing in the regenerative medicine space.
“StemBioSys is pleased to participate in this important collaborative contract,” said Bob Hutchens, StemBioSys president and CEO. “We believe the output from this work has the potential to accelerate the transition of effective stem cell therapy from research to therapeutic applications.”
With local bioscience industry leaders now working to convince the Genetics Policy Institute to return its summit to San Antonio – possibly as soon as 2018 – biotech leaders from across the U.S. can agree that the future of regenerative medicine hinges on reliable access to high quality stem cells.
“We’re honored to have been awarded this contract. Ultimately, patients around the world could benefit from the work we do,” Cap said. “The confidence MTEC has in our proposal reinforces the importance of exploring the ability of regenerative medicine therapies to improve health outcomes.”
Top image: BioBridge Global will develop a potent food source for hMSC cell culture evaluating a number of derivative components from adult and umbilical cord blood products. Photo courtesy of BioBridge Global.