“The fields of synthetic biology and gene editing are evolving to take cellular therapies to the next level by bringing advanced controls to the complex therapeutic environments,” said Dr. Jon Rowley, Founder and Chief Product Officer, RoosterBio, Inc., adding, “As the medical device technology segment rapidly moves towards incorporating living cells into next generation products, researchers and scientists are ‘forward engineering’ their products in ways not possible just a few years ago. Rapid implementation in clinical testing to ‘de-risk’ new therapeutic approaches and business models are of utmost importance to the field which is now seeing an accelerating pace of new products using truly convergent technologies,” he said.
The coalescence of a nascent field to address common issues in science, engineering and manufacturing together is critical to the success of the regenerative manufacturing industry as a whole. Siloes in the scientific development, utilizing non-scalable manufacturing practices, makes it difficult to see tissue engineering becoming commonplace. ARMI | BioFabUSA, and its members, are bringing together the people and technologies to make the hope of large human composite tissue manufacturing a reality.
“Our mission at RoosterBio is to be the fuel for regenerative cures on a global scale. We are working to radically simplify the production of therapeutic cells and tissues, and to accelerate speed to the clinic and to market,” Dr. Rowley explained. “Regenerative Medicine requires vast numbers of cells, often billions to tens of billions to manufacture even small numbers of consistent tissue lots. Obtaining these cell numbers is both technically and economically challenging.
At RoosterBio, the team breaks down the technical and cost barrier of generating billions of cells, truly democratizing this piece of the biofabrication puzzle. The company, founded in 2013 to specifically address the industry-wide bottleneck that is the scarcity of high quality and scalable cellular starting materials for product development and clinical manufacturing, is a pioneer in Regenerative Medicine (RM) manufacturing, with a focus on human mesenchymal stem/stromal cells (hMSC) raw materials, bioprocess design, and production technologies.
“RoosterBio solved a critical bottleneck in hMSC production by launching a system that enabled anyone to generate significant quantities of high-quality, secure and scalable cells in a fraction of the time, and at a fraction of the cost,” continuing, “With RoosterBio products, anyone can become an expert in the hMSC manufacturing supply chain required to accomplish the mission of tissue engineering.”
The company’s products have simplified and standardized how hMSCs are used in the development of Regenerative Medicine products and are ushering in a new era of productivity and standardization into the field, accelerating the road to discovery in regenerative medicine.
“At RoosterBio we are focused on introducing innovative products that help usher in a new era of productivity and standardization in the field, with a passion directed towards empowering life-saving cures to be discovered in Regenerative Medicine,” he said.
The momentum for hMSC-based technologies is growing, and manufacturing sciences are paving the way to improved economies of scale, reduced costs of goods and democratized hMSC-based products. Widespread abundance of a standardized hMSC supply chain will enable this technology to be readily incorporated into new application and next generation hMSC products.
“To fully grasp the potential of hMSCs to drive the Regenerative Medicine industry, it can be helpful to consider them in terms of ubiquitous technology like microchips. RoosterBio views hMSCs not as tools for research; but as complicated pieces of technology. The hMSCs necessitate controlled and scalable manufacturing processes with defined parameters that lend their critical quality attributes,” he explained, adding, “By eliminating the technical barriers and providing standardized manufacturing solutions, RoosterBio hopes to have the same impact on the regenerative medicine industry that Intel had on the computer industry.”
MSCs are poised to have tremendous impact on Regenerative Medicine applications ranging from tissue engineering to gene editing and there are over 900 registered clinical trials utilizing hMSCs with more than 100 trials being added each year since 2011, and an average of 416 million cells used per patient. By enabling large-scale manufacturing of hMSCs, RoosterBio’s goal is to drive a 10 fold increase in the numbers of hMSC clinical trials over the next 10 years.
“RoosterBio aims to be the leading provider of hMSC technologies to fuel the Regenerative Medicine revolution and we will continue to develop and deliver products focused on simplifying product and process development, enabling scalable cell manufacturing, new application development, and shortening the time to the clinic and market,” he commented.
When discussing why RoosterBio joined ARMI, Dr. Rowley said, “We recognized the tremendous value ARMI could provide to the future of biofabrication and provided Dr. Tom Bollenbach, CTO, ARMI|BioFabUSA, with a letter of support, including cost share, as one of the foundational partners on the initial application – which ARMI then won.”
In addition, RoosterBio is paving the way for rapid clinical translation and commercialization by providing readily translating research and development work from the bench to the clinic with its cGMP clinical-grade media and the only commercially available, off-the-shelf cGMP clinical grade hMSCs.
“We are in close geographical proximity to the great work being conducted at Ft. Detrick and we stand ready to support our nations Warfighters when we chose to team with multiple consortiums competing for the government’s Biofabrication Manufacturing Innovation Institute project call, now BioFabUSA, as the hMSC experts.”
RoosterBio has been granted funding, through the Department of Defense (DoD) under the Medical Technology Enterprise Consortium (MTEC), and in collaboration with BioBridge Global, GenCure, and the United States Army Institute of Surgical Research, a project to establish a 50-L XF MSC manufacturing process.
“This effort consists of developing a seed train and a suspension culture process that scales up to an 80-L PBS bioreactor, a scale that is critical to generate the cell numbers necessary for clinical therapies,” Dr. Rowley explained, adding, “The process incorporates XF cells, XF microcarriers, and an XF fed-batch bioprocess media system. The downstream process will include microcarrier separation, continuous centrifugation for volume reduction and cell washing, vial filling, controlled rate cryopreservation, and storage, with each unit operation platform identified by the process scale.”
In addition to industry partnerships, RoosterBio participates in several other national consortia, including the National Institute for Innovation in Manufacturing Biopharmaceuticals, the National Institute of Standards and Technology, the Alliance for Regenerative Medicine, and the National Science Foundation Engineering Research Center for Cell Manufacturing Technologies (CMaT) to drive: innovation in manufacturing sciences; democratization & the standardization of stem cell technologies; and making practical the large-scale manufacturing of engineered tissues, all in an effort to pave the road for the future of Regenerative Medicine as an industry.