RoosterBio and GenCure expand collaboration to provide end-to-end solutions for hMSC-based therapies

RoosterBio selects GenCure as its preferred manufacturer to leverage its scalable 
technology platform, accelerating the initiation of first-in-man studies
October 2, 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.