THANK YOU FOR SUBSCRIBING
× 
Startup City Weekly Brief
Be first to read the latest tech news, Industry Leader's Insights, and CIO interviews of medium and large enterprises exclusively from Startup City
Startup City
Margot Connor, CEO
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.
RoosterBio News
Sartorius Collaborates with RoosterBio to Advance Downstream Purification Processes for the Manufacture of Exosomes
(RoosterBio) to address purification challenges and establish scalable downstream manufacturing processes for exosome-based therapies. Through this collaboration, Sartorius and RoosterBio will provide best-in-class solutions and expertise for a human mesenchymal stem/stromal cell (hMSC) – based exosome production platform that delivers industry-leading yield, purity, and potency. Additionally, this collaboration will focus on the development of comprehensive analytical techniques for the characterization of exosomes and the entire spectrum of extracellular vesicles (EVs) to establish quantitative strategies for quality control of exosome purification intermediates and final drug product. Collaboration between Sartorius and RoosterBio in the field of Cell and Gene therapy has existed for almost two years for the industrialization of cell-based regenerative cures. It now will take a step further to commercialize the Exosome production and purification process using our technologies.
Sartorius and RoosterBio will develop scalable platform purification processes using Sartorius’ comprehensive toolbox of solutions to maximize exosome productivity while maintaining therapeutic attributes. Sartorius’s Biostat STR® manufacturing bioreactor platform, process analytical technologies (PAT) toolbox, along with RoosterBio’s hMSC banks, RoosterNourish™ hMSC cell growth medium, and RoosterCollect™ EV production medium will be used for upstream manufacture of exosomes at large scale. For the development of downstream purification methods, Sartorius’s scalable filtration equipment, Sartoflow® Smart and Sartoflow® Advanced will be leveraged for clarification, concentration, and formulation of exosomes in combination with column chromatography unit operations. Sartorius’ analytical platforms, including PATfix® HPLC, Virus Counter®, and Incucyte®, will be utilized for automated real-time process analysis and evaluation of purification process efficiency. This collaborative development effort, conducted in RoosterBio’s state-of-the-art process development laboratories in Frederick, MD, will simplify multi-step therapeutic development processes by providing robust, end-to-end platform technologies and protocols that researchers can easily adopt to accelerate development timelines and incorporate a scalable platform approach into their manufacturing processes.
“Sartorius, a leading solutions provider is delighted to enter into a collaboration with RoosterBio to develop a robust process for Exosome production. With advanced and innovative Sartorius downstream technologies for both chromatography and filtration along with state-of-the-art analytical tools, we would work with RoosterBio team for process development for this emerging modality,” said Michaela Pischke, Head of the Business Area Separation Technologies at Sartorius. “Together we merge our technologies, RoosterBio’s Clinical MSC & EV solution portfolio and Sartorius’ regulatory-compliant bioprocess manufacturing solutions, and industry expertise to deliver the bundled solutions for enabling fast-track early drug development and robust, cost-effective, scalable manufacturing process for Exosomes.”
“We are delighted to continue our highly impactful partnership with Sartorius, as this collaboration builds upon our previous process development initiative to establish scalable stirred tank bioreactor expansion processes for hMSCs,” said Tim Kelly, Ph.D., CEO of RoosterBio. “Exosomes offer extremely high utility as a new therapeutic modality with the potential to address unmet medical needs. The cell and gene therapy industry will greatly benefit from access to robust, scalable, end-to-end solutions for the production and characterization of native and engineered exosome therapeutics. By combining our industry-leading MSC and exosome technology platform with Sartorius’ best-in-class bioprocess solutions and expertise, we will deliver transformational value to advance the clinical development of this new class of therapies to patients around the world.”
Sartorius and RoosterBio will leverage the data from this collaboration to provide application notes, technology presentations, and other guidance materials designed to address the most significant challenges faced by the biomanufacturing industry.
A Profile of Sartorius
The Sartorius Group is a leading international partner of life science research and the biopharmaceutical industry. With innovative laboratory instruments and consumables, the Group’s Lab Products & Services Division concentrates on serving the needs of laboratories performing research and quality control at pharma and biopharma companies and those of academic research institutes. The Bioprocess Solutions Division, with its broad product portfolio focusing on single-use solutions, helps customers to manufacture biotech medications and vaccines safely and efficiently. The Group has been annually growing by double digits on average and has been regularly expanding its portfolio by acquisitions of complementary technologies. In fiscal 2021, the company earned sales revenue of some 3.45 billion euros. At the end of 2021, nearly 14,000 people were employed at the Group’s approximately 60 manufacturing and sales sites, serving customers around the globe.