LIMS drives the use of services to combat Covid-19


As laboratories develop new services or adapt their existing workflows to support research

and testing for Covid-19, LIMS software has become integral to the increase in sample throughput. LIMS also provides reporting tools and opportunities to automate experiments, such as PCR testing, allowing scientists to increase their efficiency in spite of Covid-19 restrictions. All lab-based industries feel the

pressure of Covid-19. Even those not directly working on the virus have to deal with reduced staff numbers in the laboratory, stricter regimes for cleaning and contamination, and increased requirements for collaboration and reporting remotely. Those that are working directly with Covid-19, either through vaccine development or environmental and personnel testing, need to be able to deliver increased numbers of samples and provide assurances that data integrity can be maintained. Laboratory Informatics Management

System (LIMS) software packages can help organisations quickly scale up their sample throughput and help mitigate remote working practices by providing remote access and in-built reporting tools, that let scientists and researchers share data with their colleagues more easily.

Human challenge models for Covid-19 Hvivo specialises in viral challenge studies and laboratory services supporting product development for customers developing antivirals, vaccines and respiratory therapeutics. The company has now begun developing human challenge studies for Covid-19 to help scientists better understand the efficacy of a vaccine. Human challenge

24 Scientific Computing World Winter 2021

studies take healthy volunteers that are not from high-risk groups, inoculate them with a vaccine, then intentionally infect them with a particular virus so that their progress can be monitored. Hvivo then monitors patients for a given period of time to check viral load and viral shedding until they are healthy and can return home. Adam French, director of laboratory

operations, explains: ‘Hvivo runs human challenge studies where we take healthy volunteers and administer a virus, normally flu or HIV or RSV to test vaccines for treatment against those diseases. ‘We are also working with the UK

government’s task force on setting up the first Covid-19 human challenge model,

“They are admitted as fully-healthy subjects. We monitor them and record their symptoms”

which we are doing in partnership with Imperial College London and the Royal Free Hospital. ‘For many years we have offered

seasonal testing for seasonal coronaviruses and many other viruses, which means that we are in a fantastic position to be able to use those assays for Covid-19.’

Human challenge models enable

companies to develop a better understanding of their vaccine in a small number of participants very quickly. As the subjects are inoculated and infected at a known point in time, the models can provide more accurate data than traditional field trials. ‘We have one of the largest units, at

24 bed units. We now have an additional facility with 19 rooms and we have 22 rooms at the Royal Free Hospital specifically for use with Covid. That combination is the biggest setup for viral challenge studies,’ said French. ‘We recruit healthy volunteers, just as

you would have for any normal clinical trial. It is an in-patient model so they come into our facility, depending on the virus, for up to 15 days. They are admitted as fully-healthy fully-screened subjects. We monitor them and record their symptoms. We take samples to measure their viral load and the viral shedding, and then we can see that return back down to healthy. Once they are fully healthy – which is why they are with us for 15 days – they go home,’ added French.

Human challenge models sit between

phase one and phase two trials. The information provided by the challenge model can then be used to help organisations make the decision to continue a vaccine’s development onto phase two trials. As these trials can be very expensive, gathering as much good data as possible in a short time-frame is important for vaccine development and the companies that invest in them. ‘Compared to a field trial, you would

need to give thousands of people the vaccine and then sit and wait to see if any of them catch it,’ said French. ‘You know exactly when they got it, so there is no guessing and you get the baseline samples immediately, whereas with the classic model they do not present until they are already ill and they have already had the virus for a number of days. ‘This allows the data to be very clean,

so you can use a much smaller number of subjects. Instead of thousands and thousands it could be only 60 or 80,’ added French. Generating this data quickly enables

companies to make swift decisions when developing vaccines. ‘Or, if the data is extremely good from the challenge study, it could enable them to get the funding they need to move on to phase three trials,’ said French. These studies help organisations reduce risk and provide them with accurate data to quickly inform the decision making process. But to scale up these human challenge models from 24 subjects to more than 60 requires Hvivo to rapidly increase the number of samples it can manage. To do this, the team adopted Labware LIMS to manage samples, increase automation, provide reporting tools and remote access to data. ‘LIMS systems are amazing tools and

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