The initiative led to the development of regenerative medicine manufacturing systems for standardized and scalable hMSC bioproduction.
FREDERICK, MD. (PRWEB) APRIL 15, 2020
RoosterBio Inc., a leading supplier of human mesenchymal stem/stromal cell (hMSC) working cell banks and hMSC bioprocess systems, announces that the Medical Technology Enterprise Consortium (MTEC) recognized a multi-institution team with a “Prototype of the Year” award at MTEC’s 4th Annual Membership Meeting in March. The Regenerative Medicine (RegenMed) biomanufacturing collaboration had created a team initiative led by GenCure, a subsidiary of BioBridge Global, along with StemBioSys, the U.S. Army Institute of Surgical Research, and RoosterBio to build standardized and scalable RegenMed manufacturing solutions. MTEC, a non-profit government funded technology consortium, operates to confront the problems of wounded warriors with advanced biomedical solutions, including those for massive tissue and organ damage.
MTEC’s “Prototype of the Year” award spotlights breakthroughs developed by RoosterBio and its collaborators since MTEC’s 2016 assigned contract of $7.8M to standardize large-scale manufacturing capabilities for clinical grade hMSCs. Clinical applications of this new platform are translatable towards diverse RegenMed-targetable indications with scalable, off-the-shelf systems. This team’s success will facilitate broad adoption of cell manufacturing technology to empower product developers solving real world health challenges. Access to this scalable production platform, including hMSC starting and ancillary production materials, is available through RoosterBio’s commercial channels.
In response to the RFP titled “Biomanufacturing for Regenerative Medicine,” the team executed on its project titled “Commercial Scale-Up of Bone Marrow-Derived Mesenchymal Stem Cells for Regenerative Medicine.” This application was crafted to develop and technology-transfer an hMSC manufacturing process that was scalable, was completely xeno-fee, maintained hMSC quality attributes across platforms, and could be transferred to a cGMP production facility. This initiative successfully demonstrated across all milestones that the scalable bioreactor process could effectively bridge these wide-ranging production scales while maintaining product quality.
Specifically, as a partner on this team, RoosterBio helped to pioneer:
- A completely xeno-free (XF) fed-batch microcarrier-based expansion process for hMSCs that scaled to a 50L culture volume, along with associated closed system and automated downstream processing; (HERE, link to related scientific poster presented at ISCT 2019)
- A commercialized cGMP-grade, xeno-free fed-batch bioprocess media system along with bioprocess recommendations specific for hMSC working cell banks, so that institutions with aims to deploy hMSCs within therapeutic product development could have rapid access to scalable manufacturing platforms; also,
- The complete system achieved two to three-fold above target cell yields and productivity metrics unparalleled with other systems, and this was transferred to GenCure’s contract manufacturing business unit for customer implementation under cGMP.
MTEC’s contract allowed the collaboration partners to show that hMSCs could successfully be manufactured at commercially relevant scales and still meet all their quality assurance benchmarks across the jump in manufacturing platforms. Becky Butler Cap, Chief Operating Officer of GenCure, credited strong team performance for this award, “We began this project with a shared vision and sets of complementary skills that allowed us to address together what none of us could have done independently. Together, we have created new capabilities and opportunities for the industry.”
Jon Rowley, PhD, Founder and Chief Product Officer of RoosterBio said, “With the assistance of this award, this team solved significant regenerative medicine product and process development challenges, and we are better equipped today to fuel the rapid commercialization of scalable regenerative cures.”
Since the MTEC contract ended in 2019, RoosterBio has been leveraging the work performed with bone marrow-derived hMSCs into other areas. hMSC-derived extracellular vesicles (EVs) or exosomes are a new and exciting class of therapies that also require large scale bioproduction. Accordingly, RoosterBio has adapted the hMSC production platform into an hMSC-EV manufacturing platform (HERE, link to related data poster). RoosterBio has also extended this technology to umbilical cord-derived hMSC systems, extending the therapeutic cell applications to more cell types (HERE, link to related 2020 blog entry showing data). Additional desirable advancements are to increase hMSC yields to beyond one billion cells per liter, as well as to further scale the 50L system to several hundred liters to achieve log enhancements in productivity and product yields.
About RoosterBio, Inc.
RoosterBio, Inc. is a privately held cell manufacturing platform technology company focused on accelerating the development of a sustainable Regenerative Medicine industry, one customer at a time. RoosterBio’s products are high-volume, cost-effective, and well-characterized adult human mesenchymal stem/stromal cells (hMSCs) paired with highly engineered media systems. RoosterBio has simplified and standardized how living cells are purchased, expanded, and used in development, leading to marked time and cost savings for customers. RoosterBio’s innovative products and collaborative relationships are ushering in a new era of productivity and standardization into the field. Visit http://www.roosterbio.com.
“With the assistance of this award, this team solved significant regenerative medicine product and process development challenges, and we are better equipped today to fuel the rapid commercialization of scalable regenerative cure”- Jon Rowley, PhD, Founder and Chief Product Officer of RoosterBio