Latest news with #Cellares'
Yahoo
10-04-2025
- Business
- Yahoo
Cellares and University of Wisconsin School of Medicine and Public Health to Automate Clinical-Scale Production of CRISPR-Edited CAR-T for Solid Tumors
Strategic collaboration aims to facilitate the manufacturing of UW–Madison's internally developed CAR-T investigational therapy Partnership seeks to address cell therapy manufacturing bottlenecks and accelerate development towards clinical trials Clinical scale manufacturing of cell therapy assets provides latest validation of Cell Shuttle's ability to empower partners to seamlessly scale production SAN FRANCISCO & MADISON, Wis., April 10, 2025--(BUSINESS WIRE)--Cellares, the pioneering Integrated Development and Manufacturing Organization (IDMO), has announced a strategic collaboration with the University of Wisconsin School of Medicine and Public Health to automate the manufacturing of a CRISPR-edited GD2 CAR-T investigational therapy. Cellares' Cell Shuttle™ supports early-phase biotechnology and academic cell therapy developers by providing an integrated, automated solution enabling immediate economies of scale and up to 50% lower batch prices compared to conventional CDMOs. As cell therapy assets mature, the platform ensures a seamless transition from clinical development to commercial-scale manufacturing, eliminating the need for costly process redesigns and multiple technology transfers and accelerating time-to-market for innovative therapies. The collaboration highlights Cellares' commitment to empowering principal investigators and researchers in academic institutions by providing access to an automated, reproducible, and scalable manufacturing platform at the earliest stages of clinical development. By leveraging the Cell Shuttle's ability to simultaneously manufacture multiple cell therapy products in parallel, this partnership overcomes longstanding manufacturing bottlenecks caused by limited manufacturing capacity. This approach shortens the journey from proof-of-concept in the lab to an investigational therapy suitable for clinical trials, ultimately aiming to improve care for patients with solid tumors. It also demonstrates how the Cell Shuttle is an automated solution for cell therapy developers of all stages, allowing them to seamlessly scale up as their manufacturing needs evolve. "Solid tumors can be challenging to treat, and many patients have limited therapeutic options," said Fabian Gerlinghaus, Co-founder and CEO of Cellares. "By collaborating with researchers at the University of Wisconsin–Madison on their CRISPR-edited GD2 CAR-T product, we remove the manufacturing barriers that can hinder promising research. Our Cell Shuttle automates and scales production to a clinical level, which accelerates the transition from academic innovation to investigational therapy and brings hope to those who need new treatment options." By enabling the CRISPR-edited GD2 CAR-T project at University of Wisconsin–Madison to achieve clinical-scale manufacturing earlier, the partnership can help unlock potential investment into the experimental therapy and expedite its path to initial human trials. The Cell Shuttle automates key steps that traditionally slow down development, thus enabling life-saving discoveries to advance more quickly. Cellares encourages collaboration with researchers, academic institutions, and commercial partners at all stages of their projects, demonstrating its unwavering commitment to advancing the field of cell therapy and expanding patient access to next-generation treatments. For more information on the Cell Shuttle and Cellares' scalable manufacturing solutions, please visit About University of Wisconsin School of Medicine and Public Health The University of Wisconsin School of Medicine and Public Health is recognized as one of the nation's leading institutions in health sciences education, research, and service. Founded in 1907 as the medical school of the University of Wisconsin–Madison, in 2005 it became the nation's first school to integrate the disciplines of medicine and public health. With a deep commitment to a vision of healthy people and healthy communities, we translate discovery into application and interconnect clinical care, education and research. The school employs more than 5,400 faculty and staff and provides educational opportunities for nearly 2,400 students and postgraduate trainees. Grants awarded to School of Medicine and Public Health principal investigators in fiscal year 2023 totaled $641 million in federal and non-federal awards. Some of the nation's leading researchers, educators, and clinicians are among the faculty, including several National Medal of Science recipients and National Academy of Science honorees. For more information, visit About Cellares Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company's Cell Shuttle™ integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. While the Cell Shuttle™ automates cell therapy manufacturing, the Cell Q™ automates quality control at high throughput, both for in-process and batch release QC, addressing both manufacturing and QC bottlenecks. Cell Shuttles and Cell Qs will be deployed in Cellares' IDMO Smart Factories around the world, enabling each Smart Factory to produce 10 times as many cell therapy batches as conventional CDMOs with the same facility size and number of employees. Partnering with Cellares enables academic medical centers, biotechnology companies, and pharmaceutical companies to accelerate cell therapy development, scale-out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand. The company is headquartered in South San Francisco, California with its first commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. Cellares is building a global network of IDMO Smart Factories with additional facilities under construction in Europe and Japan. The company is backed by world-class investors and has raised over $355 million in financing. For more information about Cellares, please visit View source version on Contacts Cellares Contacts Investors:ir@ Media:pr@
Yahoo
19-03-2025
- Business
- Yahoo
Cellares and Cabaletta Bio Successfully Complete Manufacturing Technology Adoption Program for Rese-cel Using the Cell Shuttle™ Platform
Technology Adoption Program (TAP) program success demonstrates the ability of Cellares' IDMO Smart Factory to automate, lower costs and scale out manufacturing for Cabaletta Bio's clinical-stage CAR T program to treat patients with autoimmune diseases. SOUTH SAN FRANCISCO, Calif., March 19, 2025--(BUSINESS WIRE)--Cellares, the first Integrated Development and Manufacturing Organization (IDMO), has concluded the Technology Adoption Program (TAP) on its automated cell therapy manufacturing Cell Shuttle™ for resecabtagene autoleucel, (rese-cel, previously known as CABA-201). Rese-cel is the lead clinical candidate in development by Cabaletta Bio, a biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. This successful collaboration facilitates the opportunity to engage in a clinical and commercial manufacturing relationship. Cellares' TAP assessed the feasibility of using Cellares' innovative Cell Shuttle platform to automate the manufacturing of Cabaletta's rese-cel drug product, a CD19-targeting CAR T cell therapy designed to treat patients with a broad range of autoimmune diseases. The TAP successfully delivered automated, concurrent manufacture of multiple rese-cel batches on a single Cell Shuttle. Cabaletta Bio and Cellares are now working towards the goal of manufacturing cGMP cell therapy batches to be delivered to patients. The Cellares network of global IDMO Smart Factories planned for the US, Europe, and Japan has the potential to provide Cabaletta Bio with the ability to automate, lower costs, and scale out manufacturing. Additionally, this partnership may facilitate global expansion of rese-cel via rapid technology transfer to additional IDMO Smart Factories. This has the potential to allow Cabaletta Bio to achieve the global scale required to meet the total patient demand across multiple autoimmune diseases, including myositis (~70,000 patients in the U.S.), scleroderma (~90,000 patients in the U.S.) and lupus nephritis (~100,000 patients in the U.S.), in a fraction of the time and initial investment it would typically take to develop and deliver global supply for these large patient populations. Cellares' Cell Shuttle performed all unit operations in an automated manner, including cell isolation, enrichment, gene editing, activation, and expansion. Each unit operation met predefined in-process requirements. The automated process delivered drug products that met pre-defined quality ranges. "Through our partnership with Cellares, our teams have successfully achieved proof of concept for the ability to automate the rese-cel cellular drug substance manufacturing process. I believe that the potential increase in capacity, meaningful reduction in costs, and rapid global technology transfer offers a potential solution for the global scale out of rese-cel for patients with autoimmune disease," said Gwendolyn Binder, President, Science and Technology at Cabaletta Bio. "We look forward to continuing our work together to complete activities required to enable use of the Cell Shuttle in clinical trials to support the delivery of these potentially curative autologous therapies to more patients with autoimmune diseases." "The success of this Technology Adoption Program (TAP) demonstrates the effectiveness of the Cell Shuttle as a scalable, automated, and cost-effective platform for the manufacturing of cell therapies. Working with Cabaletta Bio proves that small biotech companies can successfully partner with Cellares to benefit from next-generation automation," said Fabian Gerlinghaus, CEO of Cellares. "We are excited to contribute to the advancement of rese-cel and the delivery of life-changing therapies to patients worldwide." Cellares IDMO Smart Factories allow clients to effectively realize economies of scale even at the low batch numbers required by clients in early clinical development. As clinical development proceeds and the number of batches required grows, the technology allows for the seamless expansion of manufacturing capacity up to commercial volumes of cell therapy batches. These capabilities have the potential to enable Cabaletta Bio to meet the large total global demand from patients with autoimmune disease. About Cellares Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company's Cell Shuttle™ integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. While the Cell Shuttle automates cell therapy manufacturing, the Cell Q™ automates quality control both for in-process and release testing. Cell Shuttles™ and Cell Qs™ will be deployed in Cellares' Smart Factories around the world, enabling each Smart Factory to produce 10 times as many cell therapy batches as a conventional CDMO with the same facility size and headcount. Partnering with Cellares enables early-stage cell therapy developers advantages of immediate, small-volume economies of scale as well as the ability to scale seamlessly to meet the total global patient demand for commercially approved therapies. The company is headquartered in South San Francisco, California with its first commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. Cellares is building a global network of IDMO Smart Factories with additional facilities under construction in Europe and Japan. The company is backed by world-class investors and has raised over $355 million in financing. About Cabaletta Bio Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated with a single weight-based dosing regimen across the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio's headquarters and labs are located in Philadelphia, PA. For more information, please visit and connect with us on LinkedIn. About rese-cel Rese-cel is a 4-1BB-containing fully human CD19-CAR T cell investigational therapy for patients with autoimmune diseases where B cells contribute to the initiation and/or maintenance of disease. Following a one-time infusion of a weight-based dose, rese-cel is designed to transiently and deeply deplete all CD19-positive cells in both the peripheral circulation and within tissues. This approach has the potential to reset the immune system and result in profound clinical responses without chronic therapy requirements in patients. Cabaletta is currently evaluating rese-cel in the RESET™ (REstoring SElf-Tolerance) clinical development program which includes multiple disease-specific, company-sponsored clinical trials across expanding portfolios of autoimmune diseases in a broad range of therapeutic areas, including rheumatology, neurology and dermatology. For more information about Cellares, please visit View source version on Contacts Cellares ContactsInvestors:ir@ Media:pr@ Sign in to access your portfolio
