SI-traceable reference materials for vaccines
There is a massive international effort to develop a COVID-19 vaccine, with over 150 candidates in clinical trials. Vaccines can show variability in their physical and biological properties, and manufacturers need to ensure performance consistency from development to batch release. To succeed in this, new reference materials based on prototype vaccine platforms are needed. In addition, effective management and tracing of viral pandemics requires reference materials to ensure accurate and reliable detection.
It is vital to formulate and validate suitable reference standards that exhibit the physical and biological properties of viruses and virus-like structures to benchmark the physicochemical and biological attributes of vaccines. In collaboration with the NHS, NPL set up an inter-comparison to validate virus-like particles using high resolution electron microscopy, so that they can be used as reference materials for the characterisation of vaccines and the diagnosis of viral diseases.
NPL, with VAMAS and NIST, launched an international call for inter-laboratory comparisons in response to COVID-19, inviting proposals to characterise and validate materials and methods. This activity sits under the VAMAS TWA40 chaired by NPL.
NPL worked on the development of reference virus-like particles exhibiting nanoscale properties and characteristics suitable for accurate, differential measurements of cells, viruses and virus-like structures in clinical samples. The comparison studies helped improve repeatability and reproducibility of proposed methods and materials, and where applicable, validated measurement results with traceability to the SI. These characteristics remain fundamental to ensuring the quality, approval and delivery of safe and effective vaccines and will help improve the repeatability and reproducibility of diagnostic methods.
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