Looking To The Future: Scaling to Support Late Phase Clinical Testing


When efforts to fight the emerging COVID-19 pandemic began in January 2020, there was little data available for research and development teams to work with as they began developing a response to the virus.


Within the first year of the pandemic, thanks to collaboration between key partners like UK Health Security Agency (UKHSA), Bill & Melinda Gates Foundation (BMGF), and Coalition for Epidemic Preparedness Innovation (CEPI), we have been able to build a toolbox of qualified assays to use as we combat the virus, most that were validated within the first year of development. These assays then helped to support vaccine companies as they developed initial vaccine candidates for the SARS-CoV-2 virus. More recently, the assays have been used extensively to evaluate the impact of known and emerging variants on different vaccines.


As the world continues to monitor variants of interest and variants of concern (VOI/VOC), we are no longer lacking the data needed to take action.


Letting Data Drive Us Forward

There exist uncertainties about the efficacy of existing vaccines on variants and the duration of their immunological protection, making it unrealistic to believe that the SARS-CoV-2 R&D efforts will cease at this time. However, two years of dealing with the SARS-CoV-2 pandemic has left us with considerable data to use to better inform our actions.


As VOI/VOC emerge, each new variant requires a new pseudotyped virus to be produced based on the genetic makeup of the variant and the testing process must be adapted. Results from these new tests are shared with vaccine manufacturers, who then test their vaccine candidate against new VOI/VOC before determining if they need to modify formulation and/or dosing to ensure no immune escape. As vaccine developers continue to respond to emerging variants, the number of participants in clinical studies has grown, leading to an exponential increase in efficacy testing demand and complexity.


To respond to this challenge, Nexelis identified points of redundancy and automated steps in the testing process to maximize efficiency, while maintaining the highest standards of clinical testing. By selecting steps of their assays to automate, while ensuring the automation itself has not impacted the quality of the results, Nexelis has increased testing capacity to tens of thousands of tests per month to support clinical trials.


In order to maintain the fight against COVID-19, the industry must remain agile and ready to adapt as new variants emerge and laboratories continue to face capacity issues.


Preparing For What’s Next

Nexelis intends to maintain a capacity available to SARS-CoV-2 projects and we are in active discussions around initiatives to shorten developmental processes with governmental and non-governmental organizations. In May 2021, Nexelis initiated the deployment of BSL-3 laboratories to further support SARS-CoV-2 vaccine development. These laboratories will also be used to develop assays supporting vaccine evaluation for re-emerging, resurging or newly emerging diseases. The current pandemic has made one thing abundantly clear, the world needs to be better prepared for the next Disease X.


To read more about how Nexelis is responding to SARS-CoV-2 variants and working to more effectively deliver future vaccines, you can read our new ebook “Through A CRO’s Perspective: Innovative, Agile Solutions In Vaccine Efficacy Testing”.