全球CDMO如何克服合成方面的挑战

Spread across two buildings, Sai Life Sciences’ Alderley Park home houses chemistry and analytical labs fully equipped with the latest technology for contract synthesis. In their chemistry labs, Sai has a significant amount of equipment from Radleys which allows them to scale their processes from a few milliliters up to 35 L scale in their scale-up lab.

全球CDMO如何克服合成方面的挑战

图片来源:Radleys

全球CDMO如何克服合成方面的挑战

SAI化学家在日常工作中面临的一些主要挑战,尤其是在综合方面,包括极度紧张的时间表,同时试图完全按时向客户提供全面的规格。

Many of the challenges faced are related to efficiently conducting the maximum number of reactions possible and with good quality results, so that those results can be used to feed into subsequent experiments and delivered to customers on time.

在研究小型项目时,真正关注并行实验。需要的是易于使用的灵活设备,可提供质量结果,并使工作能够尽2020欧洲杯下注官网可能高效地完成

时间是任何项目的关键因素。因此,公司在流程开发,路线侦察和扩大规模上花费的时间有限。因此,作为化学家,并行操作实验的能力至关重要。

对于大多数项目,需要使用实验设计来尝试和访问答案比传统手段更快地访问答案。这意味着项目的发展速度更快,这对客户很重要。他们不想在实际实现材料扩展之前浪费时间进行流程开发。

The Radleys Mya 4 Reaction Station adds the complexity of being able to screen a number of reactions at different temperatures. The beauty of the Mya 4 from a chemist's perspective is that it can operate in a variety of modes and screen up to 32 reactions across four different temperatures in small vials, which is really helpful at the very start of a project.

As scale-up is initiated, the ability to run four experiments at four different temperatures with overhead stirring is crucial because it allows chemists to see how those processes will scale up. That is also important when doing heterogeneous reactions and crystallization.

When looking to scale up, the customer desires both speed and quality. Work needs to be done to ensure that when scale-up takes place, those processes are scaled up efficiently, avoiding the need to repeat or rework batches.

随着操作的扩展,需要跟踪和追踪这些过程,以确保未来的扩展不会延迟,并且材料的交付也是按时的。

当他们的工艺化学家从克扩展到千克尺度时,出现了其他挑战,所使用的设备必须能够应对规模和体积的增加。2020欧洲杯下注官网大规模工作时,设备需要代表也将在更大规模的情况下使用的设备,即搬进工厂2020欧洲杯下注官网。我T对于能够使用尽快与植物容器的设备沿着设备进行移动至关重要,这就是反应器准备就绪的家族真2020欧洲杯下注官网正增加价值的地方。

Radleys Reactor就绪和反应器就绪的飞行员平台允许使用船舶,这些容器模拟SAI的飞行员和制造工厂中的船只,并在不到30分钟的时间内灵活地在这些平台上的容器之间切换。它们还具有出色的数据记录功能,并与AVA Lab Control软件结合使用,可在网站之间进行无缝的技术传输。

当从反应堆准备(100 mL到5 L)转移到反应堆的飞行员(5 L到35 L)中时,主要优点之一是它看起来与用户完全相同。因此,当他们进入大规模实验室时,他们使用的是35 L的容器,该容器具有相同的控件和与普通实验室中使用相同的操作方式。

Sai’s process research labs over in India also have the exact same equipment, which makes transferring processes over to them and vice versa relatively straightforward, as the same equipment is being used on each site. This is, in effect, an efficient technology transfer.

全球CDMO如何克服合成方面的挑战

图片来源:Radleys

拉德利的技术支持

购买Radleys的设备时,很容易获得技术支持和售2020欧洲杯下注官网后服务。每当Radleys客户对设备有查询或问题时,Radleys总是在手头上提供帮助,回答任何问题并保持企业步入正轨。2020欧洲杯下注官网

在SAI等公司,客户在正确的时间和正确的纯度中寻求正确的材料。Radleys的设备和支持套餐有助于实现2020欧洲杯下注官网此类目标,因为其可靠性和出色的服务:如果需要快速解决,可以做到。

Customers also desire intellectual property behind that manufacturing process, and Radleys’ equipment offers automatic data logging capability so that a summary of what has happened can be created and taken forward.

This means that businesses that use Radleys’ equipment are highly competitive as they can deliver the projects that their clients need in the fastest time possible.

SAI是合同开发和制造组织。我们与制药公司和生物技术公司合作,以帮助提供其药物,开发包裹并为其制造商业量。在曼彻斯特,我们非常专注于发展方面。我们在这里进行非GMP制造,但是我们的网站是一个流程研究和开发中心,我们设计过程并开始考虑这些过程的扩展。

Andrew Kennedy, Site Head at Sai Life Sciences, Manchester

全球CDMO如何克服合成方面的挑战

图片来源:Radleys

Why do Pharmaceutical Companies Use CDMOs Like Sai?

Over the past decade, pharmaceutical companies have started to outsource a lot more work. They have reduced their internal footprints and have started to contract that work out to companies like Sai. Smaller biotechs do not have the internal capability, so they also need that support. Sai is there to assist those companies in the development of their projects.

与制药公司和生物技术公司的合作是非常不同的,因为制药公司通常具有丰富的内部经验,生物技术滞后,这意味着可能有必要帮助推动其发展。SAI能够通过他们的药物开发旅程来帮助这些不同类型的客户。

尽管这是曼彻斯特网站的独特卖点,但SAI的整体公司目标是整个项目生命周期的服务提供,从发现一直到发布。

Sai Life Sciences is fairly unique in the sense that operations take place in both the UK and India. In India, the main focus is discovery, development and manufacture, whereas, in the UK, the focus is on the development side. This means consistency in processes and equipment is of utmost importance.

Therefore, using Radleys’ technology on both sites means that Sai can work on processes in the UK, and then transfer those processes over to India to benefit from that low-cost manufacturing option while also offering its clients excellence in process R&D.

As Sai positions itself as a process research and development center of excellence, the focus on route scouting, process development and small scale-up are central to its operations. Sai has the equipment to screen reactions on a small scale and then gradually moves the development to slightly larger scales. The maximum scale Sai accommodates is 35 L, which spans from a 1 ml vial to the 35 L range.

如果一个项目需要的量要比这更大,那么SAI可以将这些流程转移到印度的地点,在该地点,在该地点,在试点规模或商业制造业上继续运营。从过程的角度来看,Radleys的设备使Sai可以无缝地执行此操作。2020欧洲杯下注官网

Radleys的设2020欧洲杯下注官网备,例如Radleys Carousels和Radleys Mya 4,可以在此过程中早期设计这些平行实验方面有助于。无论是筛选替代综合途径还是寻求优化过程条件,Radleys旋转木马都提供了12个位置的选项-12个不同的测试管以在单个温度下运行。

全球CDMO如何克服合成方面的挑战

图片来源:Radleys

克服规模的挑战

Once screening experiments have been completed, the scaling-up process can then begin. Radleys' Reactor-Ready is used to facilitate this.

Radleys AVA软件能够编程特定的反应并实现反应坡道和程序添加,然后映射这些过程的过程参数数据。然后将此信息传递给其他部门,以便可以开始进行扩展化学。

Reactor-Ready is an extremely versatile piece of technology as it can operate from 250 ml up to 5 L, and that offers chemists a great amount of flexibility in terms of the scale they operate. This is useful when materials are in short supply and chemists do not have enough material to run large batches.

AVA软件允许用户对化学编程进行编程,并在反应堆中使用这些化学作用,因为它收集了所有相关的过程数据,这些数据可以帮助化学家对过程安全性有更深入的了解。这些数据也可以用于鼓励用户将其设计过程转移到较大的船只中。

Radleys的飞行尺度反应堆范围为5至35升,最多可提供一两公斤。

准备反应器的过程传输是无缝的,这意味着所有相关的过程数据都可以使用Pilot Reactor Ready Ready设备访问,然后可以将其传递给工程工程团队,准备转移到飞行员工厂或制造工厂2020欧洲杯下注官网在替代地点。

全球CDMO如何克服合成方面的挑战

图片来源:Radleys

Sai’s Partnership with Radleys

SAI首次建立实验室时,它只使用了一些设备供应商,因为它允许他们与该公司建立关系,这意味着它可以易于访2020欧洲杯下注官网问支持,培训工具和资源(例如网络研讨会)。

Radleys可以快速进行维修和维护。与多个供应商合作时,很难安排任何维护,并且由于SAI一开始是一家小型企业,因此对公司而言,专注于一个供应商并建立合作伙伴关系非常重要。

Radleys还与葛兰素史克(Glaxosmithkline)等大型公司有关系,该公司在行业的各个层面和规模上也拥有丰富的经验。由于该公司在过去两年中迅速发展,这确实使Sai受益匪浅。

SAI现在增加了使用Mya 4s,反应堆读物等的数量,以适应​​化学家数量的增加,并且与Radleys建立了如此牢固的关系有助于支持SAI的增长,

大型制药公司想要CDMOSto be largely self-sufficient; They want to be able to leave a project with a CDMO and simply return at the end when the project is finished.

因此,SAI能够产生的科学质量以及在其使用的设备方面的交付质欧洲杯线上买球量都是至关重要的参数。2020欧洲杯下注官网

For smaller biotechs, value may go beyond delivery and process development. Therefore, biotechs will benefit from additional support mechanisms that companies like Sai can provide with the help of Radleys' reliable service and equipment.

Learn how Radleys' synthesis equipment is accelerating contract research at SAI Life Sciences in this video interview:

Learn how Radleys synthesis equipment is accelerating contract research at SAI Life Sciences

Video Credit: Radleys

此信息已从Radleys提供的材料中采购,审查和调整。欧洲杯足球竞彩

有关此消息来源的更多信息,请访问radleys。

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