Cellares and Cabaletta Bio Successfully Complete Manufacturing Technology Adoption Program for Rese-cel Using the Cell Shuttle™ Platform
Cellares and Cabaletta Bio have successfully completed their Technology Adoption Program (TAP) for manufacturing rese-cel using the Cell Shuttle™ platform. The collaboration demonstrates the capability of Cellares' IDMO Smart Factory to automate and scale manufacturing for Cabaletta's clinical-stage CAR T program targeting autoimmune diseases.
The TAP successfully achieved automated, concurrent production of multiple rese-cel batches on a single Cell Shuttle. The platform performed all unit operations automatically, including cell isolation, enrichment, gene editing, activation, and expansion, meeting predefined quality requirements.
This partnership could enable Cabaletta Bio to meet global patient demand across multiple autoimmune conditions, including:
- Myositis (~70,000 US patients)
- Scleroderma (~90,000 US patients)
- Lupus nephritis (~100,000 US patients)
Through Cellares' network of planned global IDMO Smart Factories in the US, Europe, and Japan, the collaboration aims to reduce costs and enable rapid technology transfer for global expansion of rese-cel manufacturing.
Cellares e Cabaletta Bio hanno completato con successo il loro Programma di Adozione della Tecnologia (TAP) per la produzione di rese-cel utilizzando la piattaforma Cell Shuttle™. La collaborazione dimostra la capacità della Smart Factory IDMO di Cellares di automatizzare e scalare la produzione per il programma CAR T in fase clinica di Cabaletta, mirato alle malattie autoimmuni.
Il TAP ha raggiunto con successo la produzione automatizzata e simultanea di più lotti di rese-cel su un singolo Cell Shuttle. La piattaforma ha eseguito automaticamente tutte le operazioni unitarie, inclusi isolamento cellulare, arricchimento, editing genetico, attivazione ed espansione, rispettando i requisiti di qualità prestabiliti.
Questa partnership potrebbe consentire a Cabaletta Bio di soddisfare la domanda globale di pazienti in diverse condizioni autoimmuni, tra cui:
- Miocardite (~70.000 pazienti negli Stati Uniti)
- Sclerodermia (~90.000 pazienti negli Stati Uniti)
- Lupus nefritico (~100.000 pazienti negli Stati Uniti)
Attraverso la rete di Smart Factories IDMO pianificate da Cellares negli Stati Uniti, in Europa e in Giappone, la collaborazione mira a ridurre i costi e a consentire un rapido trasferimento tecnologico per l'espansione globale della produzione di rese-cel.
Cellares y Cabaletta Bio han completado con éxito su Programa de Adopción de Tecnología (TAP) para la fabricación de rese-cel utilizando la plataforma Cell Shuttle™. La colaboración demuestra la capacidad de la Fábrica Inteligente IDMO de Cellares para automatizar y escalar la producción para el programa CAR T en etapa clínica de Cabaletta, dirigido a enfermedades autoinmunes.
El TAP logró con éxito la producción automatizada y concurrente de múltiples lotes de rese-cel en un solo Cell Shuttle. La plataforma realizó automáticamente todas las operaciones unitarias, incluyendo aislamiento celular, enriquecimiento, edición genética, activación y expansión, cumpliendo con los requisitos de calidad predefinidos.
Esta asociación podría permitir a Cabaletta Bio satisfacer la demanda global de pacientes en diversas condiciones autoinmunes, incluyendo:
- Miocitis (~70,000 pacientes en EE. UU.)
- Lupus nefritico (~100,000 pacientes en EE. UU.)
A través de la red de Fábricas Inteligentes IDMO planificadas por Cellares en EE. UU., Europa y Japón, la colaboración busca reducir costos y permitir una rápida transferencia de tecnología para la expansión global de la fabricación de rese-cel.
셀라레스와 카발레타 바이오는 Cell Shuttle™ 플랫폼을 사용하여 레세-셀 제조를 위한 기술 채택 프로그램(TAP)을 성공적으로 완료했습니다. 이 협력은 자가면역 질환을 목표로 하는 카발레타의 임상 단계 CAR T 프로그램을 자동화하고 확장할 수 있는 셀라레스의 IDMO 스마트 팩토리의 능력을 보여줍니다.
TAP은 단일 Cell Shuttle에서 여러 레세-셀 배치의 자동화된 동시 생산을 성공적으로 달성했습니다. 이 플랫폼은 세포 분리, 농축, 유전자 편집, 활성화 및 확장을 포함한 모든 단위 작업을 자동으로 수행하며, 미리 정의된 품질 요구 사항을 충족했습니다.
이 파트너십은 카발레타 바이오가 다음과 같은 여러 자가면역 질환에 대한 글로벌 환자 수요를 충족할 수 있도록 할 수 있습니다:
- 근염(~70,000명의 미국 환자)
- 경화증(~90,000명의 미국 환자)
- 루프스 신염(~100,000명의 미국 환자)
셀라레스의 미국, 유럽 및 일본에 계획된 글로벌 IDMO 스마트 팩토리 네트워크를 통해 이 협력은 비용을 절감하고 레세-셀 제조의 글로벌 확장을 위한 빠른 기술 이전을 가능하게 하는 것을 목표로 합니다.
Cellares et Cabaletta Bio ont réussi à compléter leur Programme d'Adoption de Technologie (TAP) pour la fabrication de rese-cel en utilisant la plateforme Cell Shuttle™. Cette collaboration démontre la capacité de l'Usine Intelligente IDMO de Cellares à automatiser et à étendre la production du programme CAR T de Cabaletta, en phase clinique, visant les maladies auto-immunes.
Le TAP a réussi à atteindre une production automatisée et simultanée de plusieurs lots de rese-cel sur un seul Cell Shuttle. La plateforme a exécuté automatiquement toutes les opérations unitaires, y compris l'isolement cellulaire, l'enrichissement, l'édition génétique, l'activation et l'expansion, tout en respectant les exigences de qualité prédéfinies.
Ce partenariat pourrait permettre à Cabaletta Bio de répondre à la demande mondiale des patients dans plusieurs conditions auto-immunes, notamment :
- Myosite (~70 000 patients aux États-Unis)
- Sclérodermie (~90 000 patients aux États-Unis)
- Néphrite lupique (~100 000 patients aux États-Unis)
Grâce au réseau d'Usines Intelligentes IDMO prévues par Cellares aux États-Unis, en Europe et au Japon, la collaboration vise à réduire les coûts et à permettre un transfert technologique rapide pour l'expansion mondiale de la fabrication de rese-cel.
Cellares und Cabaletta Bio haben erfolgreich ihr Technologieadoptionsprogramm (TAP) zur Herstellung von rese-cel mit der Cell Shuttle™-Plattform abgeschlossen. Die Zusammenarbeit zeigt die Fähigkeit der IDMO Smart Factory von Cellares, die Produktion für das klinische CAR T-Programm von Cabaletta, das auf Autoimmunerkrankungen abzielt, zu automatisieren und zu skalieren.
Das TAP erreichte erfolgreich die automatisierte, gleichzeitige Produktion mehrerer rese-cel Chargen auf einem einzigen Cell Shuttle. Die Plattform führte alle Einzeloperationen automatisch durch, einschließlich Zellisolierung, Anreicherung, Genbearbeitung, Aktivierung und Expansion, und erfüllte die vordefinierten Qualitätsanforderungen.
Diese Partnerschaft könnte es Cabaletta Bio ermöglichen, die globale Patientennachfrage in mehreren Autoimmunerkrankungen zu decken, darunter:
- Myositis (~70.000 Patienten in den USA)
- Sclerodermie (~90.000 Patienten in den USA)
- Lupusnephritis (~100.000 Patienten in den USA)
Durch das Netzwerk geplanter globaler IDMO Smart Factories von Cellares in den USA, Europa und Japan zielt die Zusammenarbeit darauf ab, die Kosten zu senken und einen schnellen Technologietransfer für die globale Expansion der rese-cel Herstellung zu ermöglichen.
- Successful automation of rese-cel manufacturing process demonstrated
- Potential for significant cost reduction in manufacturing
- Capability to scale production for large patient populations
- Global manufacturing network enables rapid market expansion
- Successfully completed all predefined quality requirements
- Manufacturing relationship still pending final agreement
- Clinical manufacturing approval not yet secured
Insights
The successful completion of the Technology Adoption Program (TAP) between Cellares and Cabaletta Bio represents a significant manufacturing breakthrough for rese-cel, Cabaletta's CD19-targeting CAR-T therapy for autoimmune diseases. This development directly addresses one of the most critical challenges in cell therapy commercialization: scalable, cost-effective manufacturing.
The achievement demonstrates that Cellares' Cell Shuttle platform can successfully automate all critical unit operations including cell isolation, enrichment, gene editing, activation, and expansion while meeting predefined quality parameters. This automation capability is particularly valuable for Cabaletta's business model, which targets large autoimmune disease populations including myositis (
Most CAR-T manufacturing processes remain highly manual, labor-intensive, and difficult to scale. The successful demonstration of concurrent manufacturing of multiple rese-cel batches on a single Cell Shuttle indicates potential for dramatic improvements in manufacturing throughput while maintaining quality consistency. This partnership could enable Cabaletta to achieve the necessary scale while controlling manufacturing costs - typically one of the largest expense categories for cell therapy companies.
The partners' progression toward cGMP manufacturing suggests this technology could support Cabaletta's ongoing clinical development efforts, potentially accelerating their path to market. The planned global footprint of Cellares' IDMO Smart Factories across the US, Europe and Japan would facilitate rapid technology transfer and manufacturing scale-up to meet global demand without massive upfront investment in manufacturing infrastructure.
This manufacturing partnership between Cabaletta Bio and Cellares represents a potential paradigm shift in how CAR-T therapies might be deployed for autoimmune conditions. The traditional bottleneck for autologous cell therapies has been manufacturing complexity and cost, which becomes particularly problematic when targeting large disease populations like those mentioned in the article.
The clinical implications are substantial given the combined patient population of approximately 260,000 in the US alone across myositis, scleroderma, and lupus nephritis. These conditions currently lack curative options and often require lifelong immunosuppressive treatments with significant side effects and incomplete efficacy.
Rese-cel, a CD19-targeting CAR-T therapy, builds on emerging evidence that B-cell depletion can induce deep remissions in certain autoimmune conditions. The approach attempts to improve upon existing B-cell depleting antibodies like rituximab by potentially offering more complete and durable B-cell depletion, addressing a root cause of autoimmune pathology rather than merely managing symptoms.
The manufacturing solution described could overcome one of the primary obstacles to widespread adoption of CAR-T for non-malignant conditions: producing sufficient therapy supply to meet demand while keeping costs manageable enough for payer acceptance. Without such manufacturing innovations, even clinically effective cell therapies would likely remain inaccessible to most autoimmune patients due to production constraints and prohibitive economics.
The potential for global manufacturing capability is particularly relevant given the worldwide distribution of these autoimmune conditions and would support equitable access across different healthcare markets should rese-cel prove effective in ongoing and future clinical trials.
This manufacturing partnership represents a strategic advantage for Cabaletta Bio, addressing one of the most significant barriers to commercialization in cell therapy: scalable, cost-effective production. With a market cap of approximately
The collaboration with Cellares could fundamentally alter Cabaletta's manufacturing economics and capacity limitations, potentially enabling the company to pursue indications with much larger patient populations than typically targeted by cell therapy developers. The combined US patient population for the three mentioned indications exceeds 260,000 patients - orders of magnitude larger than most approved CAR-T indications in oncology.
Establishing manufacturing feasibility on the Cell Shuttle platform significantly de-risks Cabaletta's development pathway by demonstrating a viable path to commercial-scale production without requiring massive capital investment in manufacturing infrastructure. The ability to utilize Cellares' network of planned global manufacturing facilities would allow Cabaletta to deploy capital more efficiently toward clinical development rather than building and operating manufacturing facilities.
For a company with resources, this "manufacturing-as-a-service" approach provides flexibility to scale production in line with clinical success and commercial uptake. The concurrent batch production capability demonstrated in the TAP program suggests potential for meaningful unit cost reductions compared to traditional CAR-T manufacturing processes.
This partnership enhances Cabaletta's competitive positioning among autoimmune-focused cell therapy developers by addressing the manufacturing scalability challenge that has historically cell therapy applications primarily to rare oncology indications rather than more prevalent conditions like autoimmune diseases.
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.
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,
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
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
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 cellares.com.
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Source: Cellares
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