Altasciences Qualifies Quantitative Serological Assay for Detection of SARS-CoV-2 IgG Antibodies
Altasciences, working with the National Research Council of Canada (NRC), has qualified a quantitative serological assay for the detection of SARS-CoV-2 IgG antibodies, to support vaccine development in studies from discovery to Phase II.
The development of this assay represents an important endpoint in vaccine development, serving to ensure an antibody immune response is generated against the vaccine, and the response ultimately correlates with neutralization of the COVID-19 virus.
Dr. Lynne Le Sauteur, Vice President, Laboratory Sciences, shares what makes this assay qualification unique: “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. 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. It was a truly collaborative achievement.”
Altasciences has over 260 laboratory sciences experts specialized in bioanalysis, ligand binding assays, mass spectrometry, immunology, biomarkers, and molecular biology generating the quality data needed for successful preclinical to clinical drug and vaccine development.
Altasciences worked with the NRC to test various antigens and select the best reagents for the assay. In addition, the NRC produced and characterized the spike protein of the SARS-CoV-2 virus that was used in the testing.
Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
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