Brian Feth, Co-founder & CEO
The field of cell biology has had a dearth of major innovations in recent decades. Globally, most labs still use the standard 65 year old cell biology tools like CO2 incubators, tissue culture plastics, and animal-derived serums to culture, store, and study human cells. According to Brian Feth, co-founder and CEO of Xcell Biosciences, there is a dire need among research institutions for new ways to derive a predictive response for how a disease or drug may react in the actual patient. “Resetting the fundamentals of clinical research, our solution enables robust, controlled culture of primary cells, which are challenging cell types derived directly from patient samples. Our technology enables tunable, functional, and phenotypic control of these primary cells, as well as standard cell lines, providing scientists with high quality target and therapeutic cell populations. This provides predictive insights early in the development process for a drug and creates opportunities to improve the quality of that drug, reducing clinical failure rates, and achieving significant cost-savings,” says Feth.
Xcell Biosciences is a San Francisco-based life-science company that is breaking new ground in the cell biology landscape. Where drug companies use the human body’s immune system to leverage the patient’s tissues, which is an effective method to fight diseases like cancer, Xcell Biosciences’ technology is a game-changer.
Janette Phi, COO
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.