「英中对照」Cellular Origins与费森尤斯卡比完成CGT制造系统一期物理数字集成

For pharmaceutical companies targeting cell and gene therapies (CGTs), manufacturing is not the problem. Manufacturing at scale is. Capabilities are lagging behind the biology.对于专注于细胞和基因疗法（CGT）的制药公司而言，制造本身不是问题，规模化制造才是。制造能力一直落后于生物学的发展。

Recently, automated CGT manufacturing company Cellular Origins reached a significant milestone in its work with pharma giant Fresenius Kabi. Manufacturing costs and variability in production approaches are major challenges to the widespread adoption of CGTs, so the two have been working to integrate tech to scale and automate Fresenius’ production.近日，自动化CGT制造公司Cellular Origins在与制药巨头Fresenius Kabi的合作中达成了一个重要里程碑。制造成本和生产方式的差异性是CGT被广泛采用的主要挑战，因此双方一直致力于整合技术，以扩大Fresenius的生产规模并实现自动化。

Beginning back in late 2024, the work aims to integrate Fresenius’ Cue cell processing system with Cellular Origins’ Constellation robotic manufacturing platform. As of now, physical and digital integration of Cue and Constellation has been completed.该合作早在2024年底启动，旨在将Fresenius的Cue细胞处理系统与Cellular Origins的 Constellation机器人制造 平台相集成。截至目前，Cue与Constellation的实体和数字集成均已完成。

The latest studies with human T cells confirm that the Cue system can “reliably” execute complex and precise workflows.最新利用人类T细胞开展的研究证实，Cue系统能够“可靠地”执行复杂而精确的工作流程。

Speaking to VP at Cellular Origins, Jason Jones, about this milestone, he emphasised that the sole aim is not to eradicate human beings from the process, but to “facilitate scale”.在与Cellular Origins副总裁Jason Jones谈论这一里程碑时，他强调，唯一目的并不是将人从流程中彻底剔除，而是“促进规模化”。

Jones explains that the level of manual intervention required for CGT manufacturing is not realistic for commercial scale. “Reducing”, not eliminating, this workload will make manufacturing more realistic. From a contamination control perspective, removing the humans is only good news. Humans have hair and skin, and they breathe, which is far from ideal for controlled environments. “This is why we need closed systems,” Jones says.Jones解释说，CGT制造所需的人工干预程度对于商业规模而言并不现实。“减少”而非消除这种工作量，将使制造更具现实可行性。从污染控制的角度来看，让人员离开只会是好消息。人有毛发和皮肤，还会呼吸，这对于受控环境来说远非理想。Jones表示：“这就是我们需要封闭系统的原因。”

This is why we need closed systems这就是我们需要封闭系统的原因

Closed systems are when the manufacturing is sealed off in a controlled environment from the operators in the cleanroom. Robotics-operated automation of the processes in this closed system is a technological limitation for many. But once it can be done, there are many cost and variability reduction benefits.封闭系统是指制造过程在受控环境中与洁净室内的操作人员隔离开来。在这种封闭系统中由机器人操作实现流程自动化，对许多企业而言是一项技术局限。但一旦能够实现，就会带来许多降低成本和减少差异性的收益。

For example, a contamination event rate of 0.1% is no big deal at small scale, but becomes a huge real-event occurrence rate when you scale your manufacturing by 100, becoming “untenable”.例如，0.1%的污染事件发生率在小规模生产时算不上什么大问题，但当制造规模扩大100倍时，就会变成极高的实际事件发生率，从而“难以为继”。

In this example, Jones says that you will start to have an event weekly, rather than one or two a year. Jones说，在这个例子中，你将开始每周发生一次事件，而不是每年仅一两次。 

With scale magnifying existing contamination challenges, closed systems can be even more appealing. But this is no good if this automation is unreliable. The completion of the first phase of the Cellular Origins-Fresenius collaboration illustrated the level of focus needed to ensure the biological processes are unaffected by automation in these closed systems.随着规模放大使现有污染挑战加剧，封闭系统可能会更具吸引力。但如果这种自动化不可靠，那就毫无意义。Cellular Origins与Fresenius合作第一阶段的完成，表明了需要何等专注，才能确保这些封闭系统中的生物工艺不受自动化影响。

Automating not redeveloping a process实现自动化，而非重新开发工艺

Cellular Origins has already developed a suite of tools that allow the application of automation without changing those biological processes. “We can enable more of a closed fluid pathway, because our robotics can sterile weld plastic consumables together and collect them, without any human operation, and without the mistakes that can happen around that,” Jones explains. Cellular Origins已经开发出一套工具，可在不改变这些生物工艺的情况下应用自动化。 Jones解释说：“我们可以实现更高程度的封闭流体路径，因为我们的机器人能够将塑料耗材无菌焊接在一起并加以收集，无需任何人工操作，也不会出现这一过程中可能发生的错误。” 

Hidden in this statement is what Jones believes is the key to the Constellation platform. This is not a completely customised new robotic process, but robotic execution of an established one. Meaning the most significant aspect of the Fresenius integration may not be the robotics itself, but the fact that the underlying manufacturing process remains unchanged.这番话中隐含着Jones所认为的Constellation平台的关键。它并非完全定制的新型机器人工艺，而是对既有工艺的机器人执行。这意味着，与Fresenius集成的最重要方面可能并非机器人技术本身，而是底层制造工艺保持不变这一事实。

The integration means that the existing Fresenius Cue device can be robotically operated as is. This device is for harvest of the cell product formulation, which will be frozen for transport to the patient. Jones explains that this can now be robotically operated end-to-end, but he adds that, excitingly, the digital system has also been integrated. This means that the process data can be pulled from it and integrated upwards into applications like a manufacturing execution system (MES).此次集成意味着现有 Fresenius Cue 设备可原样由机器人操作。该设备用于收获细胞产品制剂，制剂将被冷冻后运送给患者。Jones 解释说，现在这已能实现端到端机器人操作；但他补充称，令人兴奋的是，数字系统也已完成集成。这意味着可以从中提取工艺数据，并向上集成到制造执行系统（MES）等应用中。

Between the physical and digital automation and streaming, what previously took three people three hours, takes none. Interestingly, the robot being designed to automate existing production processes means it does not just stay at one device the whole time. “It can set [a process step] up, get it running, go off and do another one on another, another Cue device, and so on”.凭借物理与数字自动化以及数据流，以往需要三个人花费三小时的工作，现在无需人力。有趣的是，该机器人旨在为现有生产工艺实现自动化，因此并非始终只停留在一台设备上。“它可以设置好[一个工艺步骤]，让其运行，然后离开，在另一台、再另一台 Cue 设备上执行另一个步骤，依此类推。”

Cell and gene therapy is a personalised approach to medicine, so unlike other pharmaceutical applications, it is, by nature, a small batch process. Automating workflow steps in this way rather than recreating the process is one of the only ways to create true scale for a unique product every time.细胞与基因治疗是一种个性化医疗方法，因此与其他制药应用不同，它本质上是一种小批量工艺。以这种方式将工作流步骤自动化，而非重建工艺，是每次都为独特产品实现真正规模化的为数不多的途径之一。

You change your process, the regulatory authority is going to say, ‘Okay, redo your clinical trials’你改变工艺，监管机构就会说：‘好，重新做你的临床试验。’

This has the added benefit of reducing regulatory needs. Developers close to commercialisation in 2026 cannot necessarily afford major revalidation exercises of their processes. “You change your process, the regulatory authority is going to say, ‘Okay, redo your clinical trials’,” Jones explains.这还有减少监管需求的额外好处。接近在 2026 年商业化的开发商未必承担得起对其工艺进行重大再验证的工作。“你改变工艺，监管机构就会说：‘好，重新做你的临床试验。’”Jones 解释道。

This approach is perfect for companies with approved or late-stage approval therapies.这种方法非常适合拥有已获批或处于审批后期疗法的公司。

Why will the Earth benefit?地球为何会受益？

Jones also reveals that with these closed systems, the teams are now mostly able to operate in a Grade C/D cleanroom. "We’re aiming for Grade C right now," he says. This “downgrading” of the environment’s required control level can reduce the energy and waste requirements. In essence, reducing the facility’s complexity will reduce operating costs.Jones 还透露，借助这些封闭系统，团队如今基本上能够在 C/D 级洁净室中操作。“我们目前的目标是 C 级，”他说。环境所需控制级别的这种“降级”可以降低能源和废弃物需求。本质上，降低设施的复杂性将减少运营成本。

Removing human workflows creates opportunities for significantly more efficient facility layouts too. Jones reveals that within this collaboration, GMP cleanroom utility increases by 30 to 35%, or in other words, GMP space required reduces by 33 to 35%. Smaller footprints reduce HVAC demand and air handling requirements, as well as facility build costs at the outset.去除人工工作流程也为显著提升设施布局效率创造了机会。Jones 透露，在本次合作中，GMP 洁净室利用率提高了 30% 至 35%，换言之，所需 GMP 空间减少了 33% 至 35%。更小的占地面积降低了 HVAC 需求和空气处理要求，也降低了初期的设施建设成本。

Cellular Origins Cue TechnologyCellular Origins Cue 技术

Multi-product facilities of the future未来的多产品设施

Many, including Jones, think that the realistic future of CGT manufacturing at scale will “inevitably” be multi-product manufacturing facilities. He thinks 包括 Jones 在内的许多人认为，CGT 规模化制造的现实未来“不可避免地”将是多产品制造设施。他认为

Not yet a Subscriber?还不是订阅用户？

This is a small extract of the full article which is available ONLY to premium content subscribers. Click below to get premium content on Cleanroom Technology. 这是全文的一小段摘录，全文 仅向优质内容订阅用户开放。 点击下方获取 Cleanroom Technology 的优质内容。

Subscribe now Already a subscriber? Sign in here. 即刻订阅 已是订阅用户？ 在此登录。