RoosterGEM™, a complete genetic engineering medium, empowers product developers to realize up to four-fold increased transduction efficiency in primary cells, and achieve a greater than 50% reduction in overall gene transfer cost.
Frederick, MD, May 20, 2021 – RoosterBio Inc., a leading supplier of human mesenchymal stem/stromal cell (hMSC) working cell banks and hMSC bioprocess systems for cell and gene therapy product developers, today announced the launch of its product RoosterGEM™, a stand-alone, complete gene transfer medium that is optimized to remove key challenges in primary cell genetic modification. RoosterGEM, abbreviated for Rooster Genetic Engineering Medium, complements RoosterBio’s hMSC cell engineering system to offer a new and streamlined path for discovery, preclinical, and applied product development research – faster than ever before.
Lentiviral vectors are a modality to import cargoes of human-designed genetic circuitry into living, ex vivo cells for many of today’s investigational and marketed gene therapy products. These agents have been extensively investigated and optimized over the past two decades, resulting in manufactured biomaterial for efficient gene delivery and integration into clinically translatable cellular therapeutics.
Originally developed with a focus on hMSCs and lentivirus, RoosterGEM’s potent enhancement of transduction efficiency can also be applied to a broader range of clinically relevant, primary cell types and gene transfer toolkits. RoosterGEM is configured to involve less manipulation by the biotechnician, saving process time and reducing opportunity for human error. RoosterGEM is readily translatable into a cGMP-compliant version which RoosterBio now has in development.
RoosterBio’s findings demonstrate that combinations of RoosterGEM alone or with its high-volume, xeno-free hMSCs resulted in two to four fold increases in percent modified hMSCs. This high performance enables a reduction in viral particle concentration and reagent expense, adding up to more than 50% cost reduction versus traditional transduction reagents in a model genetic engineering process involving banked, pre-expansion cells.
“Primary cells are traditionally difficult to transduce, requiring higher amounts of viral particles,” said Jon Rowley, PhD, founder and chief product officer of RoosterBio. “Until now, our cell and gene therapy customers have been engineering their media from the ground up. With RoosterGEM, researchers and product developers can custom-engineer their clinical transduction protocol more efficiently and focus on their viral agent to reach the clinic quicker.”
“Built with cGMP-compatible processes, RoosterGEM represents a breakthrough in practical transduction efficiency. It’s the first of more products on the way from our team toward the objective of industrially scalable genetic engineering,” added Rowley.
RoosterBio offers a product line of high-volume cGMP hMSC products to simplify and accelerate process development with Type II Master Files with the U.S. Food and Drug Administration (FDA) and prior clinical applications to expedite Investigational New Drug (IND) filing.
RoosterBio is radically streamlining the path to clinic for genetically modified working cell banks. For more information about RoosterGEM can radically simplify and accelerate process development, please contact info[email protected]
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, affordable, 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 costs savings for customers. RoosterBio’s innovative products are ushering in a new era of productivity and standardization into the field. Visit http://www.roosterbio.com.