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Xcell Biosciences
Breaking New Grounds in Cell Biology
Brian Feth, Co-founder & CEOXcell 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, COORoosterBio 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.
Xcell Biosciences News
AmplifyBio and Xcell Biosciences Announce Partnership to Manufacture Solid Tumor-Targeting TCR-T Cell Therapy
SAN FRANCISCO & SOUTH SAN FRANCISCO -Xcell Biosciences Inc. (Xcellbio), an innovative technology company focused on cell and gene therapy manufacturing applications, and AmplifyBio, a rapidly growing contract development and manufacturing organization, today announced the launch of a partnership designed to streamline and improve the manufacturing process for engineered T-cell receptor (TCR) therapies targeting solid tumors. Preliminary results of this work will be presented at the annual meeting of the International Society for Cell & Gene Therapy (ISCT 2024), taking place May 29 – June 1 in Vancouver, British Columbia.
“We are focused on enabling the development of a broad range of advanced therapies and believe there are significant opportunities for improving upon therapies that work effectively for solid tumors, from concept to commercialization,” said J. Kelly Ganjei, President and CEO of AmplifyBio. “There is a pressing need for more effective and potent therapies, and we believe that working with the Xcellbio team and their unique AVATAR Foundry platform will allow us to make significant progress in that journey, and the results from this work will help create a better sandbox for our clients.”
Across the cell and gene therapy field, scientists are looking for ways to boost the fitness and potency of T cells to turn them into more effective therapies for solid cancers, enabling therapeutic options to patients that are not available today. “Current cell therapies have been highly effective for liquid tumors, but little progress has been made for the vast majority of patients with solid tumors. With low oxygen levels, low pH, and other hostile factors, the microenvironment within solid tumors makes it very difficult for T cells to kill cancer cells,” said James Lim, co-founder and Chief Scientific Officer of Xcellbio. “Our joint development work with AmplifyBio will demonstrate how the AVATAR Foundry will improve the manufacturability and potency of engineered TCRs by significantly reducing manufacturing times and utilizing non-viral workflows to produce scalable and cost-effective therapies.”
Xcellbio previously developed the AVATAR incubator system for cell and gene therapy research and development. Its AVATAR Foundry platform is a cGMP cell therapy manufacturing platform that delivers novel capabilities for improving the potency of cell and gene therapies. In this partnership, scientists from AmplifyBio will work with the Xcellbio team to develop novel cell therapy manufacturing methods based on the AVATAR Foundry platform. The efforts will focus on identifying key elements for successful manufacture of TCR therapies, such as product characterization matrix, correlation to metabolic profile, and potency. An IND filing is expected next year to target human papillomavirus-positive (HPV+) tumors using an engineered TCR therapy.
Brian Feth, co-founder and CEO at Xcellbio, commented: “We are pleased to team up with AmplifyBio, which has a strong track record in supporting the discovery, development, and manufacture of candidate therapies. We’re excited to work together to demonstrate that T cells grown in the AVATAR system can achieve higher potency and greater tumor-killing activity compared to T cells grown in traditional incubators. This has tremendous potential to one day make a difference for patient care.”
Scientists from AmplifyBio and Xcellbio will present their joint poster, “Adapting T Cells for the Tumor Microenvironment (TME) During Manufacturing for Improved Anti-Tumor Potency,” at ISCT 2024 (poster #933). It will include data about how T cells were metabolically conditioned in the AVATAR system to improve their fitness and potency.