Rapid development of reference standards for Ebola, Lassa Fever, MERS-CoV and SARS-CoV-2 using pseudotype technology 

The National Institute for Biological Standards and Control (NIBSC) has identified pseudotypes as a technology that can facilitate the development of accredited reference standards in a significantly shorter timeframe, which is particularly important for emerging viruses. Collaboration between Temperton and NIBSC, initiated in 2015, resulted in the development of WHO-accredited nucleic acid and antibody reference reagents for Ebola. Mark Page (Head of the Emerging Viruses Group at NIBSC) states that ‘most of the WHO R&D Blueprint are pathogens in hazard group 3 or 4’, and that Temperton’s PV have been identified by NIBSC ‘an essential tool for the characterisation of candidate reference reagents, alleviating the need to work at a high containment level, which for Ebola would not have been possible as NIBSC does not possess a CL4 laboratory’. Temperton’s PV-based neutralisation assays were critical for the evaluation of the Ebola plasma standard and PV were essential for production of the nucleic acid test (NAT) standards that are made by packaging the Ebola genome inside Temperton-designed retroviral pseudotype particles. Without access to Temperton’s pseudotype technology, these standards would have taken significantly longer to develop and release. Page confirms that ‘The use of pseudotype viruses for the development of reference material has now been adopted by default at NIBSC and permits the production of standards to a responsive and fluent timeframe for the priority pathogens listed in the WHO R&D Blueprint’, and further states that ‘The impact of this is that NIBSC has been made an implementing partner with Coalition for Epidemic Preparedness Innovations (CEPI) […] to produce antibody standards to enable vaccine development against priority pathogens’. In February 2019, NIBSC, enabled by Temperton’s pseudotype technology, leveraged contracts from CEPI for 1m USD to produce standards for Lassa fever virus, and, in collaboration with Temperton, NIBSC have also produced reference reagents for MERS-CoV and SARS-CoV-2 ‘with an accelerated time frame’. Page concludes that ‘There will always be the potential for […] outbreaks that could have global impact and the VPU and NIBSC alliance is ideally suited to respond to the next emergency’.