Cellares, the first Integrated Development and Manufacturing Organization (IDMO), and the University of Wisconsin (UW) School of Medicine and Public Health today announced an expansion of their partnership to support clinical production and regulatory advancement of the university’s CRISPR-edited GD2 CAR-T investigational therapy for pediatric and adult solid tumors..

Cellares 是首家综合开发与制造组织 (IDMO)，与威斯康星大学 (UW) 医学院和公共卫生学院今天宣布扩大合作，以支持该大学针对儿童和成人实体瘤的 CRISPR 编辑 GD2 CAR-T 研究性疗法的临床生产和监管推进。

The collaboration builds on the initial partnership announced in April 2025, which focused on automating the university’s internally developed CAR-T process. Based on the strong performance and reliability demonstrated in automated manufacturing, the university selected Cellares to support the program’s transition to clinical manufacturing. .

该合作建立在2025年4月宣布的初步合作伙伴关系基础之上，最初的合作重点是自动化大学内部开发的CAR-T流程。基于在自动化制造中展现出的强大性能和可靠性，该大学选择Cellares支持该项目向临床生产的过渡。

Cellares will provide manufacturing support using its Cell Shuttle™ end-to-end automated platform and Cell Q™ automated quality control platform. Cellares will also provide regulatory expertise to support the preparation and submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA), including contributions to the Chemistry, Manufacturing and Controls (CMC) section.

Cellares 将通过其 Cell Shuttle™ 端到端自动化平台和 Cell Q™ 自动化质量控制平台提供制造支持。Cellares 还将提供监管专业知识，以支持向美国食品药品监督管理局 (FDA) 准备和提交新药临床试验 (IND) 申请，包括对化学、制造和控制 (CMC) 部分的贡献。

The university retains full ownership and leadership of the IND filing process..

大学保留对IND申请流程的完全所有权和领导权。

The GD2 CAR-T program targets solid tumors in pediatric and adult patients, initially focusing on high-grade gliomas, and could inform future studies in neuroblastoma, osteosarcoma, and melanoma, which are GD2+ cancers with limited therapeutic options in the refractory or relapsed setting. The program uses CRISPR gene editing to modify patient T cells via electroporation, an approach that requires precise, reproducible manufacturing to ensure each batch meets specifications.

GD2 CAR-T项目针对儿科和成人患者的实体瘤，最初重点关注高级别胶质瘤，并可能为未来在神经母细胞瘤、骨肉瘤和黑色素瘤中的研究提供信息，这些是GD2阳性的癌症，在难治性或复发性情况下治疗选择有限。该项目使用CRISPR基因编辑技术通过电穿孔修饰患者T细胞，这种方法需要精确且可重复的制造过程，以确保每批次产品符合规格。

The Cell Shuttle’s end-to-end automation reduces manual handling and process variability. Addressing these factors can help support advancing cell therapies to clinical trials..

细胞穿梭机的端到端自动化减少了人工操作和工艺变异性。解决这些因素有助于支持细胞疗法进入临床试验。

“Outcomes of our initial collaborative work with Cellares met the specified performance standards. We are focused on next steps for bringing this from bench to bedside,” said Christian Capitini, M.D., Professor of Pediatrics and the Jean R. Finley Professor in Pediatric Hematology and Oncology at the University of Wisconsin School of Medicine and Public Health. .

“我们与 Cellares 的初步合作成果达到了规定的性能标准。我们正专注于下一步工作，将这一成果从实验室应用到临床，”威斯康星大学医学院和公共卫生学院儿科教授、Jean R. Finley 儿科血液学和肿瘤学教授 Christian Capitini 医学博士表示。

“Academic medical centers originate many of the cell therapies that eventually reach patients, but the path from proof-of-concept to IND-ready production has historically added years to the development timeline,” said Fabian Gerlinghaus, Co-founder and Chief Executive Officer of Cellares. “We believe that automated production can shorten that path and, through this clinical manufacturing collaboration with UW, we are committed to applying the Cell Shuttle and Cell Q platforms to support the full development lifecycle.”.

“学术医疗中心发起了许多最终惠及患者的细胞疗法，但从概念验证到符合新药临床试验申请（IND）的生产过程历来都会增加数年的开发时间，”Cellares联合创始人兼首席执行官法比安·格拉林豪斯表示。“我们相信自动化生产可以缩短这一过程，通过与华盛顿大学（UW）的此次临床制造合作，我们将致力于应用Cell Shuttle和Cell Q平台，支持完整的开发生命周期。”

About the University of Wisconsin School of Medicine and Public Health

关于威斯康星大学医学院和公共卫生学院

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.

威斯康星大学医学院和公共卫生学院被公认为美国健康科学教育、研究和服务领域的领先机构之一。该学院成立于1907年，是威斯康星大学麦迪逊分校的医学院，并于2005年成为美国第一所将医学和公共卫生学科相结合的学院。

With a deep commitment to a vision of healthy people and healthy communities, the school translates discovery into application and interconnects clinical care, education and research. The school employs more than 5,600 faculty and staff and provides educational opportunities for nearly 3,000 students and postgraduate trainees.

学校怀着对健康人群和健康社区的愿景的深切承诺，将发现转化为应用，并将临床护理、教育和研究相互连接。该校拥有 5,600 多名教职员工，为近 3,000 名学生和研究生培训生提供教育机会。

For federal fiscal year 2024, the school ranked #9 in the nation among public medical schools for NIH funding according to the Blue Ridge Institute for Medical Research. 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.

根据蓝岭医学研究院的数据，在2024年联邦财政年度，该校在公立医学院中因国立卫生研究院（NIH）资助排名全美第9位。学校教职人员中包括一些美国顶尖的研究人员、教育工作者和临床医生，其中有多位国家科学奖章获得者以及国家科学院荣誉获得者。

Visit med.wisc.edu to learn more..

访问 med.wisc.edu 以了解更多信息。

About Cellares

关于Cellares

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 是首家集成开发与制造组织 (IDMO)，通过工业4.0方法为21世纪的活体药物大规模生产提供全球细胞治疗开发和制造服务。该公司使生物制药合作伙伴能够以满足患者总需求所需的产能、可靠性和经济性来开发、扩展和商业化细胞疗法。

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..

Cellares的全自动化平台——用于端到端细胞治疗制造的Cell Shuttle™和用于自动化过程中及放行质量控制的Cell Q™——已部署在其全球IDMO智能工厂网络中。这些技术提供了行业领先的制造经济性、更高的工艺成功率，并能够以与传统CDMO相当的占地面积和人员数量生产多达10倍的细胞治疗批次，从而实现行业内最低的制造成本。

Headquartered in South San Francisco, California, 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.

总部位于加利福尼亚州南旧金山的Cellares在新泽西州布里奇沃特运营其首个商业规模的IDMO智能工厂，同时正在欧洲和日本建设更多设施。通过其全球制造网络，Cellares专为支持临床和商业项目而打造，致力于扩大全球获得拯救生命的细胞疗法的机会。

For more information, visit www.cellares.com and follow Cellares on LinkedIn..

欲了解更多信息，请访问 www.cellares.com 并在 LinkedIn 上关注 Cellares。

Cellares Contacts

赛拉雷斯联系人

Business Development:

商务拓展：

bd@cellares.com

bd@cellares.com

Investors

投资者

:

：

ir@cellares.com

ir@cellares.com

Media

媒体

:

：

pr@cellares.com

pr@cellares.com

University of Wisconsin Contact

威斯康星大学联系方式

communications@med.wisc.edu

communications@med.wisc.edu

Source: cellares.com

来源：cellares.com