Frederick, Maryland (PRWEB) October 02, 2017
Biotech organizations RoosterBio Inc and GenCure announced today that they are expanding their existing collaboration by providing end-to-end solutions for hMSC (human bone marrow-derived mesenchymal stromal cell)-based therapeutic technologies. This biomanufacturing solution unites clinically relevant starting and ancillary materials with a scalable manufacturing process to deliver unprecedented adult cell manufacturing efficiencies. This expanded collaboration aims to shorten development timelines, simplify technology transfers, and deliver commercially viable cost structures, thereby to accelerate regenerative medicine removing years and millions of dollars from current commercial pathways.
GenCure, which is launching contract development and manufacturing services appropriately-sized for multiple phases of development, will use RoosterBio’s off-the-shelf hMSC and bioprocess media products and leverage their expertise as a leader in hMSC manufacturing innovation.
Based in San Antonio, TX, not-for-profit GenCure, a 501(c)(3) wholly owned subsidiary of BioBridge Global, provides cGMP-compliant manufacturing of both tissue and cell-based products, and has been selected as RoosterBio’s preferred manufacturing organization. GenCure will leverage BioBridge Global’s expertise in process and analytical development, quality control testing, quality management systems and regulatory guidance, to support all stages of product development from preclinical evaluation, to clinical phase human trials, through to commercialization.
The GenCure-RoosterBio partnership evolved from the complementary core competencies of each organization, laying the foundation for a lasting impact on the industry. GenCure brings deep expertise in cGMP manufacturing, cord blood banking, cell processing, high volume quality control testing, and the Pharma-grade quality systems that have supported these businesses for several years. RoosterBio’s extensive experience in producing high-quality, clinically relevant hMSCs for product development and rapid clinical translation can be simply integrated into the GenCure infrastructure, bringing new-found efficiencies to the field of regenerative medicine.
“The structure of this collaboration allows projects to gain end-to-end control by increasing productivity, predictability and transparency. Using this product platform for hMSC-based technologies allows our customers to focus on their own product development efforts,” said Jon Rowley, PhD, Chief Technical Officer of RoosterBio Inc.
“RoosterBio’s innovative solutions designed to address critical industry bottlenecks are powering next-generation stem cell-based therapies, thereby accelerating regenerative medicine and empowering life-saving cures for patients worldwide,” Margot Connor, Chief Executive Officer of RoosterBio Inc. said. “Our expanded collaboration with GenCure has the potential to transform Regenerative Medicine and the standard of patient care in the next few years, as our customers rapidly move their life-saving therapies to the clinic. This partnership establishes an unprecedented paradigm shift in the stem cell tools and CDMO business models, further providing the industry with much-needed solutions.”
GenCure and RoosterBio first came together a year-ago as part of a four-organization biotech group that was awarded a contract from the Medical Technology Enterprise Consortium (MTEC), to enable the development of large-scale manufacturing capabilities for clinically-relevant stem cells. “The progress being made through the MTEC collaboration, and now our expanded focus with our new CDMO services and RoosterBio, allows us to carry out our mission, by supporting research and development efforts that will result in truly translational, tangible therapeutic benefits for patients,” said Becky Cap, Chief Operating Officer of GenCure.
About GenCure: GenCure, a subsidiary of BioBridge Global, is a not-for-profit organization focused on enabling the development of cell- and tissue-based therapies and companies in that space by providing access to source materials, cGMP manufacturing experience and clinical trials support. We focus on oncology, orthopedics and dental support through our cord blood bank, our National Marrow Donor Program apheresis center and our deceased donor tissue bank.
GenCure began operations under the South Texas Blood & Tissue Center in 1991. We were formally established in 2015 to build upon the regenerative medicine elements of our existing services in tissue, cord blood, cellular therapy and marrow and apheresis collections. Today, we use our core resources and in-house expertise in cGMP cell therapy manufacturing, quality management systems, compliance and testing to forge collaborations with outside partners, with the goal of facilitating development of new approaches for cell expansion and manufacturing at clinical and commercial scale. Visit us at https://biobridgeglobal.org/subsidiaries/gencure.
About RoosterBio Inc.: RoosterBio is a privately held biofabrication technology and products company focused on accelerating the development of a sustainable Regenerative Medicine industry, one customer at a time. RoosterBio has simplified and standardized how stem cells are purchased, expanded, and used in development, leading to marked time and cost savings for customers. RoosterBio’s innovative products are ushering a new era of productivity and standardization into the field, where researchers spend newly found time and money performing more high-value experiments, accelerating the road to discovery in Regenerative Medicine. RoosterBio serves customers worldwide. For more information, please visit http://www.roosterbio.com, or follow on Twitter (@RoosterBio), or read the blog “Democratizing Cell Technologies” (http://www.roosterbio.blogspot.com).