How a Global CDMO Overcomes Challenges in Synthesis

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.

How a Global CDMO Overcomes Challenges in Synthesis

Image Credit: Radleys

How a Global CDMO Overcomes Challenges in Synthesis

Some of the main challenges that Sai chemists face in their day-to-day work, especially on the synthesis side, include extremely tight timelines while trying to deliver to its customers on time, in full, to their specifications.

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.

When working on small-scale projects, there is a real focus on parallel experimentation. What is required is flexible equipment that is easy to use, delivers quality results and enables work to be completed as efficiently as possible.

Time is a key factor for any project. Therefore, companies are limited in terms of the amount of time that can be spent on process development, route scouting and scale-up. So as a chemist, the ability to operate experiments in parallel is vital.

For most projects, parallel reaction screening experimentation is required, using the design of experiments to try and access answers a lot quicker than by traditional means. This means that projects move along faster, and that is important for a customer. They do not want to waste time on process development before they actually achieve material scale-up.

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.

As operations are scaled up, those processes need to be tracked and traced to ensure that that future scale-up is not delayed and that the delivery of the material is also on time.

When their process chemists are scaling up from gram to kilogram scale, other challenges arise and the equipment being used must be able to cope with the increase in scale and volume. When working on a large scale, the equipment needs to be representative of what will also be used on an even larger scale i.e. moving into a plant. It is crucial to be able to move along using equipment that starts to resemble a plant vessel as soon as possible, and that is where the Reactor-Ready family really adds value.

The Radleys Reactor-Ready and Reactor-Ready Pilot platforms allow the use of vessels that simulate those in Sai’s pilot and manufacturing plants with the flexibility to switch between vessels on these platforms in less than 30 minutes. They also have excellent data logging capabilities in combination with AVA Lab Control software for seamless tech transfer between sites.

When moving from Reactor-Ready (100 mL to 5 L) into Reactor-Ready Pilot (5 L to 35 L), one of the main advantages is that it looks exactly the same to the users. So, when they enter the scale-up lab, they are using a 35 L vessel which features the same controls and the same way of operating that they are used to in the normal lab.

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.

How a Global CDMO Overcomes Challenges in Synthesis

Image Credit: Radleys

Radleys’ Technical Support

When purchasing Radleys’ equipment, technical support and after-sales service are readily available. Whenever a Radleys customer has a query or an issue with the equipment, Radleys is always on hand to help, answering any question and keeping businesses on track.

At companies like Sai, customers seek the right material at the right time and of the right purity. Radleys’ package of equipment and support helps achieve such objectives due to its reliability and excellent service: if something needs resolving quickly, it can be done.

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 is a contract development and manufacturing organization. We work with pharma companies and biotechs, to help deliver their drug substances, develop packages and manufacture commercial quantities for them. At Manchester, we are very much focused on the development side. We do non-GMP manufacture here, but our site is set up as a process research and development centre of excellence, where we design processes and start to think about the scale-up of those processes.

Andrew Kennedy, Site Head at Sai Life Sciences, Manchester

 

How a Global CDMO Overcomes Challenges in Synthesis

Image Credit: 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.

Working with pharmaceutical companies and biotechs is very different as while pharmaceutical companies usually have a wealth of internal experience, biotechs lag, meaning that it may be necessary to help drive their development. Sai is able to help those different types of customers through their journey of drug development.

While that is the unique selling point at the Manchester site, Sai’s overall company objective is in the delivery of services across the whole project life cycle, from discovery all the way through to launch.

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.

If a project requires larger volumes than this, Sai can then transfer those processes over to its sites in India, where operations continue on the pilot-scale or into commercial manufacturing. From a process perspective, Radleys’ equipment allows Sai to do this seamlessly.

Radleys’ equipment, such as the Radleys Carousels and the Radleys Mya 4, can help in terms of designing those parallel experiments early on in the processes. Whether screening for alternative routes of synthesis or looking to optimize process conditions, the Radleys Carousels offer the option of 12 places - 12 different test tubes to operate at a single temperature.

How a Global CDMO Overcomes Challenges in Synthesis

Image Credit: Radleys

Overcoming Scale-up Challenges

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

Radleys AVA software is able to program specific reactions and implement reaction ramps and program additions and then map the process parameter data from those processes. This information is then delivered to other departments so that the scale-up chemistry can begin.

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.

The AVA software allows users to program the chemistry, and operate those chemistries in the Reactor-Ready as it gathers all of the relevant process data that can help chemists gain a deeper understanding of process safety. This data can also be used to encourage users to transfer their design processes into larger vessels.

Radleys' pilot-scale reactors range from 5 to 35 L, which allows delivery of up to one or two kilos.

The process transfer of the Reactor-Ready is seamless, meaning all of the relevant process data can be accessed using pilot Reactor-Ready equipment, which can then be passed on to process engineering teams, ready to be transferred into a pilot plant or for manufacturing at an alternative site.

How a Global CDMO Overcomes Challenges in Synthesis

Image Credit: Radleys

Sai’s Partnership with Radleys

When Sai first set up its labs, it only used a few equipment suppliers as it allowed them to develop a relationship with that company, meaning that it would be easy to access support, training tools and resources such as webinars.

Radleys offers a quick turnaround on repairs and maintenance. When working with multiple suppliers, it can get quite difficult to arrange any maintenance, and because Sai was a small business at the start, it was really important for the company to focus on one supplier and build a partnership.

Radleys also has relationships with larger companies such as GlaxoSmithKline, which also has vast experience at all levels and scales of the industry. That is something that has certainly benefitted Sai as the company has rapidly grown in the last two years.

Sai has now increased the number of Mya 4s, Reactor-Readys, etc. in use to accommodate the increase in the number of chemists, and having such a strong relationship with Radleys has helped support Sai’s growth,

Large pharma companies want CDMOs to 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.

Therefore, the quality of the science that Sai is able to generate, as well as the quality of the delivery in terms of the equipment it uses, are both crucial parameters.

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 

 

This information has been sourced, reviewed and adapted from materials provided by Radleys.

For more information on this source, please visit Radleys.

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