A New Day Dawns for RoosterBio, Inc., FITCI Graduate

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RoosterBio, Inc. ’s (RBI) official transition from local incubator start-up client to a thriving, established company puts Frederick, Maryland, at the epicenter of a major field change.

“RoosterBio continues to flourish in the Frederick biotechnology ecosystem because FITCI gave us the platform to launch our company, prove our business model and secure funding." Margot Connor, CEO

On February 15, 2018, at 4:30 p.m., government, community and business leaders came together to celebrate RoosterBio, Inc.’s (RBI) official transition from local incubator start-up client to a thriving, established company that puts Frederick, Maryland, at the epicenter of a major field change. RBI is a privately held stem cell tools and technology company focused on accelerating the development of a sustainable Regenerative Medicine industry. The ribbon cutting and grand opening of their new 14,000 ft.² facility on Westview Drive signals the dawning of radical change in how companies and institutions produce, consume and use living cells. Speakers at the event include County Executive Jan Gardner, Mayor Michael O’Connor, TEDCO President/COO John Wasilisin, and the Alliance for Regenerative Medicine's Morrie Ruffin.

Until now, researchers were obligated to invest sizable resources into building deep cell banks to assure reproducible experiments and clinical trial materials. This burdensome process effectively dams the wellspring of progress, as potentially life-changing experiments wait for resource availability. RoosterBio’s stem cell tools shatter the bottleneck. Founded by scientists, the company created a first-of-its-kind “off the shelf” line of products that enables customers to leap ahead in their own research and manufacturing. In turn, these groundbreaking studies further innovation in bioprinting, cell and tissue engineering, and synthetic biology/genetic manipulation or illuminate strategies to treat ailments, such as osteoarthritis or cartilage defects, even advancing efforts to grow ligament tissue or architecturally complex bone structures and creating patient-specific medical devices.

Jon A. Rowley, PhD, Founder and Chief Technical Officer at RoosterBio, brought RBI’s core team together. Channeling the joyful exuberance of a rooster proclaiming a new day’s limitless potential, they started among other driven entrepreneurs at the Frederick Innovative Technology Center, Inc. (FITCI), a public/private entity dedicated to accelerating biotechnology, information technology and renewable energy start-up companies, in 2013. They focused on manufacturing and supplying mesenchymal stem/stromal cell (“hMSC”) systems in product configurations that enable manufacturing scale-up and clinical translation, and started shipping cell and media products to customers in February 2014. In less than five years, the company grew from six to 25 team members and 160+ customers Worldwide. They expect to double the staff in the next few years.
FITCI Chief Executive Officer, Kathie Callahan Brady counts RBI as a success story. “RoosterBio is a true market disrupter. This innovative platform, providing commercially relevant materials and processes, is generating efficiencies at their client companies like never seen before. That starts a chain of improvements that will ultimately help ease people’s suffering.” The industry is taking note, too.

RoosterBio has benefited from local Maryland funding, winning two rural Maryland manufacturing expansion grants, funding from the county supporting international trade and workforce training. In 2016, RBI was awarded a multimillion-dollar grant from a DOD-sponsored Medical Technology Enterprise Consortium (MTEC), along with several collaboration partners (US Army Institute for Surgical Research, GenCure, StemBioSys). In late 2017, RoosterBio selected MTEC collaboration partner, GenCure, as its preferred manufacturer to leverage their scalable technology platform into higher value cGMP products. These accomplishments stack up with two awards from manufacturing innovation institutes, a consortium partnership biotech National Manufacturing Innovation Institutes BioFab USA, NIIMBL, and a Cooperative Research and Development Agreement (CRADA) with the U.S. Army Institute of Surgical Research.

Margot Connor, RBI’s Chief Executive Officer, says the impact is monumental. “Our products are designed to remove several years and millions of dollars from the product development and clinical testing cycle.” She notes that there are greater than 800 current hMSC clinical trials globally. “Most analysts agree that the field of regenerative medicine is expected to exceed $50-billion by 2020.”

RoosterBio’s new Regenerative Medicine Manufacturing Sciences Center (RegenMed-MSC for short) is more than triple the space they occupied at FITCI and offers room to expand further. The location, part of a recently remodeled business campus owned by Avison Young, includes laboratories for manufacturing research, analytical and process development, quality control and stem cell manufacturing, as well as substantial warehouse capacity.

The space is filled with high-tech equipment such as a Nova Biomedical Bioprofile FLEX2, a CELLINK INKCREDIBLE 3D Bioprinter, and three different mid-scale bioreactors for cell manufacturing process development. The company plans to install a 50-liter bioreactor later this year for true scale up capabilities. Offices are bright and open with a “human-centered” design by The Verve Partnership of Baltimore, which Connor describes as, “reflective of our cooperative corporate culture.” She also credits Bates Architects PC and Tim Shanklin of Berkshire Hathaway-Bowen Realty for bringing the vision together.

Connor says, “RoosterBio continues to flourish in the Frederick biotechnology ecosystem because FITCI gave us the platform to launch our company, prove our business model and secure funding. Further support from the state and local government, as well as the exceptional local talent pool in Maryland, enabled us to grow quickly while maintaining a high-quality organization.” She recognizes the supportive cooperation among TEDCO, the Frederick Office of Economic Development and the Maryland Department of Commerce in Frederick in creating a nurturing environment for enterprise. “As our business continues to thrive, we’re excited to maintain our aggressive growth trajectory and significantly expand our stem cell biomanufacturing operations in Frederick. We think that the growth in Regenerative Medicine Manufacturing will be a key economic development driver for Maryland, and in particular Frederick, over the next 10-15 years.”

She notes that the new location affirms RBI’s commitment to pursue novel stem cell process development and production solutions delivered with an exceptional customer experience. For Connor and the RoosterBio team, Mother Nature’s alarm clock embodies their bright outlook for the future of regenerative medicine and adult stem cell therapies. “We are building a sustainable business with strong company culture that is innovative, solution focused, profitable, and is ‘making a dent’ in the Regenerative Medicine Universe by advancing the standard of medical care.”

Contributing to life saving cures is definitely something to crow about.

Get more information at RoosterBio.com or fitci.org.

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Margo Connor
RoosterBio, Inc.
+1 301-600-1058 Ext: 304
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Kathie Callahan Brady
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