Cellares recently announced it has secured a site and signed a long-term lease for a new IDMO Smart Factory at Leiden Bio Science Park (LBSP) with Dura Vermeer Commercieel Vastgoed. The facility will serve as Cellares’ European headquarters and expand the company’s global manufacturing network with dedicated regional capacity.

Cell therapy manufacturing is patient-specific and time-sensitive, making regional production capacity increasingly important as programs advance from clinical development toward commercial supply. The new Netherlands hub is designed to provide European drug developers with access to automated manufacturing infrastructure, while maintaining alignment to a common production standard across Cellares’ global facilities.

The leased premises comprise approximately 9,741 square meters (about 105,000 square feet LFA) of laboratory and office space within the Nexus building in Leiden, a newly constructed life sciences facility currently under development and expected to be delivered in the first quarter of 2026. Following delivery, Cellares plans to complete a phased fit-out to prepare the facility for operations, with initial occupancy anticipated later in 2026.

“Cell therapies are manufactured to order for each patient, and the work is time-sensitive, which makes on-continent capacity a practical requirement for European programs,” said Fabian Gerlinghaus, Co-founder and CEO of Cellares. “A European hub gives partners a local supply path while keeping control consistent across geographies through a single automated standard.”

The Leiden site is intended to support automated cell therapy manufacturing programs for European and global partners as they plan regional clinical and commercial supply. Following delivery and completion of the fit-out, the Netherlands Smart Factory is expected to deploy Cellares’ fully automated Cell Shuttle™ manufacturing platforms and Cell Q™ quality control systems to enable consistent execution and streamlined process transfer across geographies, extending the company’s global IDMO network across North America, Asia, and Europe.

“Cellares’ decision to choose Leiden demonstrates that LBSP plays a key role in facilitating companies in the field of advanced therapies as they scale toward industrial-level and standardized manufacturing,” said Stijn van de Sande, Director of Dura Vermeer Commercieel Vastgoed. “Our role is to develop and deliver an environment that can support that bar, and to work with Cellares during the fit-out so the site meets the requirements of its automated manufacturing model.”

The Netherlands site builds on Cellares’ commercial-scale IDMO Smart Factory in Bridgewater, New Jersey, and its original manufacturing operations in South San Francisco, with additional Smart Factory capacity in development in Japan. Together, these sites are designed to support reliable process transfer, accelerated scale-up, and a consistent manufacturing standard that expands patient access to cell therapies worldwide. CBRE is the global real estate advisor for Cellares.

Cellares also announced that Cabaletta Bio’s (Nasdaq: CABA) investigational CAR T cell therapy rese-cel (resecabtagene autoleucel) has received FDA clearance of an IND Amendment (INDa) to use Cellares’ Cell Shuttle™ and Cell Q™ platforms for manufacturing and QC release testing.

The clearance allows for the clinical manufacturing and release of rese-cel using Cellares’ fully automated end-to-end manufacturing and high-throughput quality control platforms, with first patient dosing anticipated in the first half of 2026. This milestone marks the Cell Shuttle and Cell Q platforms’ first use to support an active clinical program.

“Autoimmune cell therapy programs operate at a fundamentally different scale of patient demand than oncology,” said Gerlinghaus. “Achieving scalability in these larger indications is a differentiated feature of the Cellares platform. FDA approval of Cabaletta’s IND Amendment reflects regulatory confidence in the Cell Shuttle and Cell Q platforms to deliver reliable GMP drug products at scale.”

Cabaletta is advancing rese-cel across autoimmune indications with substantially larger patient populations than traditional oncology CAR T therapies, heightening the need for scalable, reliable, and operationally efficient manufacturing. The Cell Shuttle’s end-to-end automation enables standardized and consistent execution across runs, equipment, and sites, while Cell Q integrates release testing into a high-throughput, digitally enabled workflow. Implementation of the Cell Shuttle and Cell Q platforms reduces manual touchpoints, cycle times, and variability, thereby improving turnaround time and consistency in quality.

In preparation for the submission, Cabaletta and Cellares generated split apheresis comparability data demonstrating consistent performance between manual and automated manufacturing processes, supporting the transition to automated clinical production on Cellares’ technology platforms. In addition, Cellares executed a concurrent multi-batch engineering run campaign to demonstrate the capability for GMP manufacturing at a scale that meets the current clinical demand.

“Since we formed our partnership with Cellares in 2023, we believed that their fully automated manufacturing platform had the potential to change the paradigm of autologous cellular therapies by offering the promise of unprecedented scale produced reliably with minimal capital expense,” said Steven Nichtberger, MD, Co-founder, Chairman, and Chief Executive Officer of Cabaletta Bio. “The technical data we generated in collaboration with Cellares supported the IND clearance for clinical manufacturing of rese-cel in our ongoing clinical program. Initial clinical data is anticipated in 1H26 to inform GMP readiness, including supply chain logistics.”

Rese-cel (formerly referred to as CABA-201) is an investigational, autologous CAR T cell therapy engineered with a fully human CD19 binder and a 4-1BB co-stimulatory domain, designed specifically for the treatment of autoimmune diseases. Administered as a single, weight-based infusion, rese-cel is intended to transiently and deeply deplete CD19-positive cells, with the goal of resetting the immune system and achieving durable clinical responses without the need for chronic therapy. Cabaletta is evaluating rese-cel in the RESET (REstoring SElf-Tolerance) clinical development program, which includes multiple ongoing company-sponsored trials across a diverse and growing range of autoimmune diseases in rheumatology, neurology and dermatology.

Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical 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 in 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 www.cabalettabio.com.

Cellares is the first Integrated Development and Manufacturing Organization (IDMO), providing global cell therapy development and manufacturing services through an Industry 4.0 approach to the mass manufacture of the living drugs of the 21st century. The company enables biopharmaceutical partners to develop, scale, and commercialize cell therapies with the capacity, reliability, and economics required to meet total patient demand.

Cellares’ fully automated platforms—Cell Shuttle for end-to-end cell therapy manufacturing and Cell Q for automated in-process and release quality control—are deployed across its network of IDMO Smart Factories worldwide. These technologies deliver industry-leading manufacturing economics, higher process success rates, and the ability to produce up to 10× more cell therapy batches than conventional CDMOs with comparable footprint and headcount, resulting in the lowest cost of manufacturing in the industry.

Headquartered in South San Francisco, CA, Cellares operates its first commercial-scale IDMO Smart Factory in Bridgewater, New Jersey, with additional facilities under construction in Europe and Japan. Through its global manufacturing network, Cellares is purpose-built to support both clinical and commercial programs and to expand access to life-saving cell therapies worldwide. For more information, visit www.cellares.com and follow Cellares on LinkedIn.