Setting up a UK Lighthouse laboratory

Mark was leading the AstraZeneca’s newly created global High Throughput Screening centre at Alderley Park when COVID-19 hit. Then he received a phone call from Medicines Discovery Catapult, asking if he would lend his expertise to their newly formed Lighthouse Laboratory on behalf of UK Gov.

When UK Gov calls for your help…

I received a call from Prof Chris Malloy (CEO, MDC) who was acting as National Director for the Lighthouse Labs network and Prof Peter Simpson (Chief Scientific Officer, MDC), who was founding Director of the Alderley Park Lighthouse Lab. They said they thought I could help, and of course, the answer was always going to be yes. That was quickly followed up by ‘what do you need?’.

I responded to what I saw as a duty to help people after the Government’s call and joined the Lighthouse Lab network on a secondment. Despite plenty of late nights and pressures to meet testing targets, the high-octane role also has its benefits. For me, it’s the difference the lab is making for people across the country as the centre hopes to facilitate the nation’s return to post-pandemic normality, and the impact it is having in the national fight against COVID-19.

What approach was taken for the setup?

It was definitely a scaled approach. We were fortunate to have local volunteers, many from the Medicines Discovery Catapult, AstraZeneca, the University of Manchester and Cancer Research UK. We had secured a suitable laboratory and the government had secured both reagents and equipment, much of the equipment being borrowed from different universities and businesses. This enabled us and the other laboratories in the Lighthouse network to rapidly establish the screening facilities.

The Medicines Discovery Catapult was asked on 18th March 2020 to establish a screening facility and by the 7th April the first patient samples were screened. This was really important as the first few plates were targeting key workers that had to self-isolate and enabled them to come back to work if they tested negative, allowing much needed reinforcements back to the frontlines within the NHS.

Progress continued as we were able to purchase our own equipment and transition to a hired workforce. It took us 84 days to reach 1 Million samples tested. Our second, third and fourth million samples took, 59, 36 and 28 days to complete: clearly showing a building capacity and scaling of approach.

We rely on technology for everything from biological containment hoods, through RNA extraction technology and we are continuously looking for new opportunities to introduce technology and make things more efficient or of a higher quality.

Was the setup process prescriptive against guidelines?

There was a very clear framework that defined the use of specific equipment, reagents and engagement with Public Health England (PHE) and the NHS to ensure that the correct standards were met. It was really important that the government secured reagents and equipment at scale, at a time when the global communities were all doing the same, because it enabled us to focus on other areas.

The scale at which we are now operating has never been done before, so it was necessary to review and design how high throughput workflows would best work within the facilities across the networks.

We based our approach on the infrastructure of our laboratory. We were also very well positioned with many experienced staff that were eager to join the fight against COVID-19, but it was absolutely necessary that we engaged with the correct regulatory bodies, generated comparison data and reached the approved standards for a Diagnostics laboratory, so having this framework to work within was really useful.

Did you work with other UK labs and expert volunteers?

We have worked with a very large number of organisations as we have built the lighthouse laboratory here at Alderley Park. Perhaps one of the most important benefits has been working as a network: each of the Lighthouse laboratories is set up by separate organisations and local leadership and if we had not all focused on working together and sharing learning, the project would have been much harder and slower.

Locally at Alderley Park we have worked with various Universities and companies across the Northwest, including the University of Manchester and Cancer Research UK, who provided rapid volunteer responses. A key resource has been the provision of Clinical Virologist Paul Klapper, who has a Chair at the University of Manchester. In addition to this we have seen other very experienced Academic Groups contribute Virology experts to the laboratory. The groups of Professor Harris and Professor Stonehouse at the University of Leeds have been particularly important in helping us to rapidly adopt high standards and then to look at innovating our process by introducing automation to our sample handling.

What was it like to source and train specialist volunteers?

To date, more than 800 people have been involved in the project at Alderley Park.

A key part of our rapid response was the need to effectively screen and process the very large number of volunteers while simultaneously generating training capability. There are obvious challenges of identifying and training this number of people in a short time period, but the main challenge was that this changed significantly over short time periods.

Initially, it was necessary to establish quality and safety protocols with our core group of volunteers. As time passed and the organisation grew, identifying experienced leadership to take the organisation forward was a priority. In addition, as our volunteer army began to move back to their regular jobs, replacing them and growing at the desired rate became a challenge.

The incredible hard work of everyone involved enabled us to rise to these challenges and overcome them. The focus on contributing vital testing data to help the country to overcome COVID has been an incredible motivator within our teams and the scientific community.

…this project has been like nothing I have ever seen before and it has been an honour to work alongside people with a focus on delivering, doing the right thing and putting others before themselves. I really could never have imagined that what we have done would be possible.

What were the main logistical challenges when setting up the lab?

I think the simplest answer to this is scale. By centring the build of the Lighthouse laboratories in a small number of places it enabled rapid distribution networks, the focus of inspection resources, and clear communications. These advantages were all essential to the project’s rapid success. This also meant that each laboratory had to operate on a never-before-seen scale.

Each individual assay only requires a small amount of reagent and generates a relatively small amount of waste. However, when this is scaled to tens of thousands of tests it requires a military operation to manage. Quite literally, in the early stages of this project, the military came to support the logistics within the warehousing, sample receipt and delivery into the laboratory. They even helped in some locations with unpacking the samples ready for processing.

Challenges like this are replicated at each step of the process. While testing an individual sample is relatively simple, having a clear robust process and a workforce properly trained to deliver it took time to generate. Again, that’s why the modular approach was required. We only opened each part of the laboratory when it had been correctly validated and resourced.

Did you rely on any lab technologies to get the job done?

The whole Diagnostic process relies on the technology available to us from the clinically validated reagents and assays, through to the dispensing technologies. We rely on technology for everything from biological containment hoods, through RNA extraction technology and we are continuously looking for new opportunities to introduce technology and make things more efficient or of a higher quality.

I recall during the build of the laboratory in the early stages we were constrained by the number of handheld pipettes available to us, this is of course technology at its simplest form but at the time getting the pipettes and tips was challenging as every laboratory in the world was trying to do the same thing. We were fortunate and made calls to the UK Integra reps who pulled together, some personally driving the demonstration pipettes that they had at home to us, while others waited for couriers to collect them and bring them to us. The last set of pipettes arrived to us at 9:50am in the morning and by 10am they had all been checked and were all in operation in a newly opened laboratory. At the time this was pivotal in expanding our testing capability.

Did you rely on automation in addition to human skills?

Once we were in a scaling phase, we were able to transition much of our manual process to automation. At Alderley Park we formed a collaboration with Hamilton Robotics and Contained Air Solutions (CAS). We were very fortunate to have access to automation experts from AstraZeneca. Paul Harper worked with Hamilton’s experts and our Virology Experts from Leeds to combine the technology that existed within the Hamilton platforms with new algorithms to define a new standard in sample transfer. This in turn has raised the throughput and quality achievable in a new high throughput diagnostics platform within a purpose built and safe environment.

What have you learned from this project?

Within my career I have always known that believing in people, giving them an opportunity to grow and be challenged, often leads to results that you could never have imagined. However, this project has been like nothing I have ever seen before and it has been an honour to work alongside people with a focus on delivering, doing the right thing and putting others before themselves. I really could never have imagined that what we have done would be possible. Much of my role has been about helping people believe in themselves, when at times the challenges looked too great, but in any project when the right combination of people, focus and belief if brought together truly impressive things can happen.

Author: Mark Wigglesworth is Site Director for the Medicines Discovery Catapult-Lighthouse Laboratory based at Alderley Park, a Bruntwood SciTech location. md.catapult.org.uk alderleypark.co.uk  bruntwood.co.uk