期刊
VACCINE
卷 39, 期 28, 页码 3724-3730出版社
ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2021.05.047
关键词
SARS-CoV-2; COVID-19; Neutralizing antibody; Standard; Neutralization assay
资金
- National Key Research and Development Project [2020YFC0860500]
- General Program of National Natural Science Foundation of China [82073621]
- National Science and Technology Major Projects of Drug Discovery [2018ZX09101001]
- Bill & Melinda Gates Foundation [INV-006379]
- Bill and Melinda Gates Foundation [INV-006379] Funding Source: Bill and Melinda Gates Foundation
By establishing and approving the first Chinese National Standard for SARS-CoV-2 neutralizing antibody, the quality and efficacy assessment of COVID-19 vaccines and therapeutics in China has been standardized and improved.
In order to meet the domestic urgent needs of evaluating the immunogenicity of vaccines and the potency testing of therapeutic antibody products against coronavirus disease 2019 (COVID-19), the first Chinese national standards for SARS-CoV-2 neutralizing antibody were established. The potency and stability of the candidate standards were determined by neutralization assay and accelerated degradation study. The stability studies showed that the standards were stable in the short-term. The collaborative study showed that the candidate standards could reduce the variations in neutralization titers between labs and thus improve comparability of neutralizing antibody measurements. Sample 22 has been approved by the Biological Product Reference Standards Sub-Committee of the National Drug Reference Standards Committee as the first Chinese National Standard for Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) neutralizing antibody, with an assigned potency of 1,000 units per milliliter (U/ml). This standard will contribute to the standardized assessment of the quality and efficacy of vaccines and therapeutics for COVID-19 in China. (C) 2021 The Author(s). Published by Elsevier Ltd.
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