Altasciences, in collaboration with the National Research Council of Canada (NRC), has qualified a quantitative serological assay to detect the presence of SARS-CoV-2 IgG antibodies.
This supports vaccine development from research to phase II in studies.
The company noted that the development of this new assay represents an important endpoint in the development of vaccines.
It serves to ensure the generation of antibody immune response against the vaccine, and that response ultimately correlates with neutralisation of the Covid-19 virus.
Altasciences Laboratory Sciences vice-president Dr Lynne Le Sauteur said: “This assay is different from other developments in that it is quantitative, giving an indication of the magnitude of the antibody response, whereas other assays typically provide qualitative yes/no results.
“The assay was qualified in a GLP laboratory, using a source of spike protein that is reliably and robustly produced in Canada.
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“We are proud of the success of this qualification, which could not have been achieved without seamless teamwork, scientific expertise in vaccine assay development, and the source of study subject patient serum from Altasciences’ clinics (both with and without SARS-CoV-2 infection) that were needed to qualify the assay.”
The company is a mid-size contract research organisation that offers a flexible approach to both pharmaceutical and biotechnology companies for pre-clinical and clinical pharmacology studies such as formulation, manufacturing, and analytical services.
With more than 260 laboratory sciences experts, it worked with the NRC to test several antigens to select the best reagents for the assay.
The NRC has also produced and characterised the spike protein of the SARS-CoV-2 virus which was used for testing.