Articles from Cellares

Cellares, the first Integrated Development and Manufacturing Organization (IDMO), proudly announces that its Cell Shuttle™ has been granted the Advanced Manufacturing Technology (AMT) designation by the FDA’s Center for Biologics Evaluation and Research (CBER). This designation acknowledges the Cell Shuttle’s ability to automate and reliably manufacture cell therapies and represents a significant step forward in the advanced manufacturing of cell therapies.

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, the world’s first Integrated Development and Manufacturing Organization (IDMO), and a leader in automated cell therapy manufacturing, has appointed Ossama Eissa, former executive at Novartis, Lonza Biologics, and Legend Biotech, as Chief Operating Officer (COO). This appointment strengthens the Cellares leadership team in a time of rapid global expansion of the company’s IDMO manufacturing services, in response to the growing global demand for cell therapy manufacturing capacity. By leveraging its advanced automated manufacturing platforms, the Cell Shuttle™ and Cell Q™, Cellares will enable cell therapy developers to meet the total global patient demand for their cell therapies.

Cellares, the world’s first Integrated Development and Manufacturing Organization (IDMO) and a leader in automated cell therapy manufacturing, and Sony Corporation ("Sony"), a technology pioneer driving innovation in the field of flow cytometry, today announced a collaboration to jointly develop and integrate advanced flow cytometry-based cell analysis and sorting solutions into the Cellares Cell Shuttle™, an automated cell therapy manufacturing platform. Sony will leverage technologies from its CGX10 Cell Isolation System to develop new solutions. The combination of the two industry-leading technologies is expected to make Cellares’ Cell Shuttle the world’s first truly automated, end-to-end cell therapy manufacturing solution with cell analysis and sorting capabilities.

Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and commercial-scale cell therapy manufacturing, announced today the commissioning of the first cGMP Cell Shuttle™ at the IDMO Smart Factory in Bridgewater, New Jersey. This marks an important milestone on the way to a fully fitted facility, which will be capable of producing up to 40,000 standard CAR-T cell therapy doses per year, or up to 100,000 doses of novel, two-day process CAR-T cell therapies.

Cellares, a leader in cell therapy manufacturing and the world’s first Integrated Development and Manufacturing Organization (IDMO), is pleased to announce the leadership appointments of Justin McAnear as Chief Financial Officer (CFO) and Jonathan Butler as General Counsel and Corporate Secretary (GC). The addition of these seasoned tech industry leaders will strengthen the Cellares Executive Leadership Team and enable the company’s continued expansion.

Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and industrial-scale cell therapy manufacturing, today announced that Kite, a Gilead Company, will evaluate Cellares’ automated manufacturing platform, the Cell Shuttle. The data generated in this proof-of-concept evaluation will be utilized to assess viability of the Cell Shuttle as a future manufacturing option for Kite.

Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and industrial-scale cell therapy manufacturing, today unveiled Cell Q™, the first automated quality control (QC) workcell for cell therapy manufacturing. Cell Q™ addresses a critical challenge: the manual, labor-intensive, low-throughput, and expensive nature of cell therapy QC. Exclusive to Cellares’ industry-first IDMO Smart Factories, Cell Q™ will offer a substantial improvement in throughput, cost, and reproducibility compared to existing manual QC methods.

Cellares, a leader in the automation of cell therapy manufacturing and the world’s first Integrated Development and Manufacturing Organization (IDMO), today announced the addition of Christi Shaw to its Advisory Board. Ms. Shaw is a life sciences leader and advocate for patients with more than 30 years of pharmaceutical industry experience across a broad range of therapeutic areas. She formerly served as Chief Executive Officer of Kite, a Gilead Company, where she led a global team dedicated exclusively to the research, commercialization, and manufacturing of cell therapy. Under her leadership, Kite became a global leader in providing potentially curative cell therapies with multiple approved blood cancer indications in over 20 countries and led the company from treating a few hundred patients to thousands worldwide. Before Kite, she held senior executive positions at Lilly, Novartis, and Johnson & Johnson.

Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and commercial-scale cell therapy manufacturing, today announces the completion of its first current Good Manufacturing Practice (cGMP)-compliant Cell Shuttle™. The Cell Shuttle is an automated, ultra-high throughput, cell therapy manufacturing platform designed to meet global patient demand while reducing costs and process failure rates. The release of this new version of the Cell Shuttle platform is an important milestone on the way to ensuring clinical readiness by the end of 2024.

Cellares, an innovative cell therapy manufacturing company, has announced a $255 million series C fundraise to launch its new location in Somerset County. The 118,000-sq. ft. manufacturing site in Bridgewater, New Jersey is expected to create up to 350 local jobs. To commemorate the opening of this facility, Cellares will host local dignitaries for a ribbon-cutting ceremony on Monday, January 29th, to celebrate its forthcoming contributions to the local economy and support for cell therapy patients in need.

Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and industrial-scale cell therapy manufacturing, and Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced Cabaletta will evaluate Cellares’ automated manufacturing platform, the Cell Shuttle™, through Cellares’ Technology Adoption Partnership (TAP) program. As part of the collaboration, the companies have agreed on a proof-of-concept technology transfer process for the manufacture of CABA-201, Cabaletta’s clinical-stage fully human CD19-CAR T cell product candidate, using the Cell Shuttle.

Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and industrial-scale cell therapy manufacturing, announced that global biopharmaceutical company and cell therapy leader Bristol Myers Squibb (NYSE: BMY) will enter a second proof-of-concept tech transfer process for the manufacture of a CAR-T cell therapy, as part of the Cellares Technology Adoption Partnership (TAP) program. As part of this expanded agreement, Cellares will optimize, automate, and tech-transfer the additional CAR-T cell therapy process onto its automated manufacturing platform, the Cell Shuttle.