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Cellular Origins与费森尤斯·卡比签署开发协议,实现细胞和基因治疗制造的可扩展自动化

Cellular Origins, Fresenius Kabi Sign Development Agreement for Scalable Automation of Cell and Gene Therapy Manufacturing

businesswire 等信源发布 2024-10-16 21:04

可切换为仅中文


CAMBRIDGE, England & BAD HOMBURG, Germany--(BUSINESS WIRE)--Cellular Origins and Fresenius Kabi, an operating company of Fresenius, announce today they have signed a development agreement that leverages each company’s expertise in cell and gene therapies (CGTs).The agreement is designed with the goal of digitally and physically integrating Fresenius Kabi’s suite of cell therapy processing technologies within Cellular Origins’ CGT robotic manufacturing platform Constellation™.

英国剑桥和德国巴德洪堡——(商业新闻短讯)——Cellular Origins和费森尤斯(Fresenius)的运营公司费森尤斯·卡比(Fresenius Kabi)今天宣布,他们签署了一份开发协议,利用每家公司在细胞和基因治疗(CGT)方面的专业知识。该协议旨在将费森尤斯·卡比(Fresenius Kabi)的一套细胞治疗处理技术以数字和物理方式集成到Cellular Origins的CGT机器人制造平台Constellation™中。

The aim of this work is to assist cell therapy developers to manufacture their therapies at scale using their preferred processing tools..

这项工作的目的是帮助细胞疗法开发人员使用他们首选的处理工具大规模制造他们的疗法。。

Cellular Origins, a TTP Company, focuses on enabling scalable, cost-effective, and efficient manufacture of CGTs via its Constellation™ automation platform. Fresenius Kabi, a global health care company, specializes in products, technologies, and services for the therapy and care of patients with critical and chronic conditions..

Cellular Origins是一家TTP公司,专注于通过其Constellation™自动化平台实现可扩展、经济高效的CGT制造。费森尤斯·卡比(Fresenius Kabi)是一家全球医疗保健公司,专门从事治疗和护理危重和慢性病患者的产品、技术和服务。。

The work has begun with a focus on the integration of Fresenius Kabi’s Cue® Cell Processing System to target an integrated and functional system. To enable the Cue System to be fully automated with robotic consumable transport, connection, installation, deinstallation, full process operation and control and data management via the hardware and digital layer of Constellation.

这项工作已经开始,重点是集成费森尤斯·卡比的Cue®细胞处理系统,以实现集成和功能系统。通过星座的硬件和数字层,通过机器人消耗品运输、连接、安装、卸载、全过程操作和控制以及数据管理,使Cue系统实现全自动化。

This approach is intended to create fully automated 24/7 CGT manufacturing at true scale, making maximum usage of manufacturing space with the minimal number of personnel and without process change..

这种方法旨在以真正的规模创建全自动的全天候CGT制造,以最少的人员数量和不改变流程最大限度地利用制造空间。。

Fresenius Kabi has designed its Cell Therapy Technologies portfolio to provide scalable solutions to major challenges of cell therapy research and manufacture. The companies will focus their initial integration work on the Cue Cell Processing System because it is specifically designed for automated and precise small volume cell processing.

费森尤斯·卡比(Fresenius Kabi)设计了其细胞疗法技术组合,为细胞疗法研究和制造的主要挑战提供可扩展的解决方案。这些公司将把最初的集成工作集中在Cue细胞处理系统上,因为它是专门为自动化和精确的小体积细胞处理而设计的。

Cue’s flexible design and delivery of results across a wide a range of critical applications, including final formulation and culture media exchange, precisely and consistently, made it Fresenius Kabi’s lead candidate for integration with Cellular Origin’s Constellation..

。。

Cellular Origins believes that successful scaling of cell therapies requires close cross-industry collaboration and as such, has prioritised developing and strengthening alliances with leading technology providers in the field. Constellation is designed to automate the manufacturing of advanced therapies without significant process redevelopment.

Cellular Origins认为,细胞疗法的成功扩展需要密切的跨行业合作,因此,优先发展和加强与该领域领先技术提供商的联盟。Constellation旨在自动化先进疗法的制造,而无需进行重大的流程重新开发。

This collaboration will allow Cellular Origins and Fresenius Kabi to harness the experience of both teams to work toward the physical and digital integration of the Cue system within Constellation. Bolstering Constellation’s capabilities with fully automated cell processing will enable end users to improve production efficiencies while also reducing inconsistencies by alleviating the risk of human variation and error..

这种合作将使Cellular Origins和费森尤斯·卡比(Fresenius Kabi)能够利用两个团队的经验,致力于星座内Cue系统的物理和数字集成。。。

Following the focus on Cue, the collaboration contemplates focusing on Fresenius Kabi’s wider cell therapy technologies portfolio, including the Lovo® Cell Processing System and future products currently in development.

在关注Cue之后,该合作计划专注于费森尤斯·卡比(Fresenius Kabi)更广泛的细胞治疗技术组合,包括Lovo®细胞处理系统和目前正在开发的未来产品。

“Cellular Origins has developed Constellation to enable fully industrialised manufacture of cell and gene therapies,” said Dr Edwin Stone, CEO at Cellular Origins. “Forming strong collaborations is essential to ensuring the industry can implement the transformative power of automation whilst using the tools that are best for the biology and, therefore, for patients.

Cellular Origins首席执行官埃德温·斯通(EdwinStone)博士表示:“Cellular Origins开发了星座,使细胞和基因疗法的完全工业化制造成为可能。”。“形成强有力的合作对于确保行业能够实现自动化的变革能力至关重要,同时使用最适合生物学的工具,因此也最适合患者。

Fresenius Kabi is an industry-leading developer of automated technologies to support the production of cell therapies. This is why we are working closely with their team to unlock the power of automation throughout the entire manufacturing process, with the goal of bringing life-saving therapies to patients, faster and more affordably.”.

费森尤斯·卡比是支持细胞疗法生产的自动化技术的行业领先开发商。这就是为什么我们与他们的团队密切合作,在整个制造过程中释放自动化的力量,目标是更快、更实惠地为患者提供挽救生命的疗法。”。

“For Fresenius Kabi, automation is crucial to addressing some of the biggest research and manufacture challenges in our industry. This is a major reason for our collaboration with Cellular Origins,” said Dr Christian Hauer, President MedTech at Fresenius Kabi. “Our cell therapy technologies are designed with automation at their core, to provide new levels of precision and efficiency.

费森尤斯·卡比(Fresenius Kabi)医学技术总裁克里斯蒂安·豪尔(Christian Hauer)博士表示:“对于费森尤斯·卡比(Fresenius Kabi)来说,自动化对于解决我们行业中一些最大的研究和制造挑战至关重要。这是我们与细胞起源合作的主要原因。我们的细胞治疗技术以自动化为核心进行设计,以提供更高水平的精确度和效率。

By working closely with the team at Cellular Origins, we hope to advance the CGT industry by helping therapy developers embrace automation during the production process with the goal of ultimately benefitting patients.”.

通过与Cellular Origins团队的密切合作,我们希望通过帮助治疗开发人员在生产过程中实现自动化来推动CGT行业,最终使患者受益。”。

About Cellular Origins www.cellularorigins.com

关于细胞起源

Cellular Origins, a TTP Company, is focused on enabling scalable, reproduceable and efficient manufacture of cell and gene therapies (CGTs).

TTP公司Cellular Origins专注于实现细胞和基因疗法(CGT)的可扩展,可复制和高效制造。

Despite the incredible potential for CGTs in the treatment of disease, emerging therapies remain unavailable to many patients due to insufficient expertise and manufacturing capability for affordable production. With an increasing number of approved CGTs currently reaching the market, the disconnect between innovative therapies and manufacturing capabilities has led to an urgent need for solutions that provide large-scale access to cost-effective, next-generation therapeutics..

尽管CGT在治疗疾病方面具有惊人的潜力,但由于专业知识和生产能力不足,许多患者仍然无法获得新兴疗法。随着越来越多经批准的CGT目前进入市场,创新疗法与制造能力之间的脱节导致迫切需要能够大规模获得具有成本效益的下一代疗法的解决方案。。

Created to provide therapeutic developers and CDMOs access to the equipment they want, at the scale they need, Cellular Origins is bringing advanced automation from the industry 4.0 revolution to the forefront of CGT.

Cellular Origins旨在为治疗开发者和CDMOs提供他们所需的设备,以满足他们所需的规模,它将先进的自动化从工业4.0革命带到了CGT的前沿。

Cellular Origins’ Constellation is a closed, configurable, robotic platform that enables scalable, reproduceable, cost-effective and space efficient advanced therapy manufacture, consisting of highly flexible mobile robots with proprietary future-proofed, automated effectors for sterile fluid transfer.

Cellular Origins的星座是一个封闭的,可配置的机器人平台,可实现可扩展的,可复制的,具有成本效益和空间效率的先进治疗制造,由高度灵活的移动机器人组成,具有专有的经未来验证的自动效应器,用于无菌液体转移。

The modular platform can be seamlessly integrated into new and existing workflows with minimal changes, alleviating the need for process redevelopment without constraining innovation..

模块化平台可以无缝集成到新的和现有的工作流中,只需进行最小的更改,从而减轻了流程重新开发的需要,而不会限制创新。。

To find out more about Cellular Origins and its innovative cell therapy manufacture solutions, please visit https://cellularorigins.com/. Follow Cellular Origins on X (@CellularOrigins) and LinkedIn (@CellularOrigins).

要了解有关细胞起源及其创新细胞疗法制造解决方案的更多信息,请访问https://cellularorigins.com/.在X(@CellularOrigins)和LinkedIn(@CellularOrigins)上追踪细胞起源。

About Fresenius Kabi

关于费森尤斯·卡比

As a global health care company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 43,000 employees and present in over 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies..

作为一家全球医疗保健公司,费森尤斯·卡比致力于生活。该公司的产品、技术和服务用于治疗和护理危重和慢性病患者。费森尤斯·卡比(Fresenius Kabi)拥有43000多名员工,分布在100多个国家,其庞大的产品组合专注于提供高质量和救生药物和技术。。

In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status – notably as the only corporation offering both product groups.

在生物制药领域,费森尤斯·卡比为自身免疫性疾病和肿瘤学提供了尖端的生物仿制药。凭借在临床营养领域的领先市场地位,广泛的肠内和肠外产品组合对患者的营养状况产生了明显的影响,尤其是作为唯一一家同时提供这两种产品的公司。

In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care..

在MedTech,该公司提供重要的输液泵、细胞和基因治疗设备、一次性用品等。费森尤斯·卡比(Fresenius Kabi)是全球领先的采血袋和设备供应商,为全球血库和医疗保健设施提供支持。该公司的静脉注射仿制药和输液疗法每年在急诊医学、外科、肿瘤学和重症监护领域帮助挽救数百万人的生命。。

Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of almost 450 million patients annually. With Vision 2026, as part of the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of health care..

费森尤斯·卡比(Fresenius Kabi)采用整体的医疗保健方法,将经验、专业知识、创新和奉献精神独特地结合在一起,每年为近4.5亿患者的生活带来改变。凭借2026年愿景,作为#FutureFresenius战略的一部分,该公司正在开发、生产和销售新产品和技术,并渴望扩大其作为全球领先治疗供应商的地位,改善患者护理,为利益相关者创造可持续价值,塑造医疗保健的未来。。

Fresenius Kabi is an operating company of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing health care solutions on a global scale.

费森尤斯·卡比(Fresenius Kabi)是费森尤斯集团(Fresenius Group)的一家运营公司,该集团与赫利奥斯(Helios)和基罗·萨路德(Quirónsalud)一起成立于1912年。作为一个团队,费森尤斯集团的公司致力于在全球范围内提供救生和改变生命的医疗保健解决方案。

The Cue Cell Processing System is for laboratory use only and may not be used for direct transfusion. Appropriate regulatory clearance is required by the user for clinical use.

Cue细胞处理系统仅供实验室使用,不得用于直接输血。。

Refer to the Cue Cell Processing System Operator’s Manual for a complete list of warnings and precautions associated with the use of this product.

有关与使用本产品相关的警告和注意事项的完整列表,请参阅Cue Cell处理系统操作手册。

For more information, please visit www.fresenius-kabi.com.

有关更多信息,请访问www.fresenius-kabi.com。

This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing.

本版本包含前瞻性声明,这些声明会受到各种风险和不确定性的影响。由于某些因素,例如业务、经济和竞争条件的变化、监管改革、临床试验结果、汇率波动、诉讼或调查程序的不确定性以及融资的可用性,未来的结果可能与这些前瞻性声明中描述的结果存在重大差异。

Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release..

费森尤斯·卡比不承担更新本版本中前瞻性声明的任何责任。。

Management Board: Pierluigi Antonelli (Chairman), Marc Crouton, Andreas Duenkel, Dr. Christian Hauer, Dr. Marc-Alexander Mahl, Dr. Sang-Jin Pak

Chairman of the Supervisory Board: Wolfgang Kirsch

监事会主席:沃尔夫冈·基尔希

Registered Office: Bad Homburg, Germany

Commercial Register: Amtsgericht Bad Homburg - HRB 11654

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