Margot Connor, CEO
Stem cells—once thought of as powerful tools for biological discovery, are now being used to drive next-generation biotechnology innovations that are revolutionizing medical practice in a field called Regenerative Medicine. Today, with de-risked manufacturing, quality, and regulatory processes, stem cells have graduated to the classification of a true technology, paralleling transistors and microchips in the 60s and 70s. These living cells are complicated pieces of technology, but like microchips, they need to be manufactured to required quality specifications and delivered to customers in formats that enable simple incorporation into their own medical products. Setting a new paradigm for this technology phase change, RoosterBio— with its distinctive products and services—is embarking on a new era in the realm of regenerative medicine.
RoosterBio is standardizing stem cell technology, similarly to sub-components of electronic products. They offer off-the-shelf, high-quality, and “ready to use” standardized stem cell products that enable rapid implementation in development, clinical translation, and even commercialization. These products enable clients to migrate between developmental stages, positioning their products for mass distribution, while shrinking timelines and budgets along the way. “We believe that stem cells are powering the next wave of biotechnology products, and RoosterBio is shepherding this industry transition with novel product formats designed for quality, manufacturing, and regulatory specifications,” states Jon A. Rowley, Founder and Chief Technology Officer of RoosterBio. Known across continents via publications and keynoting cell manufacturing conferences, the firm’s in-depth expertise in stem cell manufacturing pushes forward a unique approach to biotechnology tools and supplies needed to develop next-gen therapeutics, with a final goal of accelerating the field of regenerative medicine.
Powering this stem cell revolution is no easy task, but RoosterBio has proven their business model and demonstrated product-market fit. From academics and applied research to small biotechs and large pharma, RoosterBio caters to them all with simplified mesenchymal stem cell (MSC) systems for cell and gene therapies, tissue and organ engineering, as well as the emerging exosome/extracellular vesicle field. “MSCs are critical raw materials in many tissues such as bone, cartilage and tendon, and are important accessory cells in organ engineering. Exosomes yielded by MSCs have the potency of stem cells without actually having to deliver the cells,” adds Margot Connor, CEO of RoosterBio.Being a product-based firm with a robust service arm, RoosterBio sells stem cells and engineered bioprocess media—a high performing liquid that accelerates cell growth—to enable clients to achieve 10X productivity gains in generating MSCs over competitive systems, radically lowering costs.
RoosterBio offers development services to customers enabling optimal utility of its products within their own processes to minimize development costs and position its clients for a scalable future. The products and processes are designed with current Good Manufacturing Practices (cGMP) requirements and the regulatory aspects related to manufacturing materials. RoosterBio has filed Master Files to the FDA for their cell and media products, eliminating two-thirds of the chemistry, manufacturing, and controls (CMC) section from clients’ investigational new drug (IND) filings, greatly simplifying the regulatory process. RoosterBio maintains a strong relationship with a number of contract manufacturing organizations (CMOs) and aids clients in process transfer. Recently, the firm assisted a large pharma company to initiate an MSC manufacturing program, quickly incorporating RoosterBio’s products and processes in their efforts. The pharma company procured its first in vivo data nearly three years faster and migrated into manufacturing process development within the first two years.
Scripting similar success stories, the firm continues to launch new innovative products into the regenerative medicine market that no other competitor is commercializing. When the field of regenerative medicine is ready for innovation, RoosterBio is at the forefront, leveraging its extensive commercial experience to ramp up cGMP production. “We plan on having the same impact on the regenerative medicine industry that Intel had on the computer industry,” concludes Rowley.