Development and characterization of standard reagents for cell-based prepandemic influenza vaccine products
Autor: | Wang-Chou Sung, Tsai-Chuan Weng, Min-Shi Lee, Chia-Chun Lai, Po-Ling Chen, Alan Yung-Chih Hu, Chun-Yang Lin, Yu-Fen Tseng, Min-Yuan Chia |
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Jazyk: | angličtina |
Rok vydání: | 2020 |
Předmět: |
Influenza vaccine
030231 tropical medicine Immunology Hemagglutinin (influenza) Hemagglutinin Glycoproteins Influenza Virus 03 medical and health sciences 0302 clinical medicine Influenza Human Immunology and Allergy Animals 030212 general & internal medicine hemagglutinin Vaccine Potency Pharmacology Standard reagents validation Avian influenza virus biology Outbreak Virology quantification Influenza Vaccines H7N9 influenza virus biology.protein Indicators and Reagents Cell based Research Article Research Paper |
Zdroj: | Human Vaccines & Immunotherapeutics article-version (VoR) Version of Record |
ISSN: | 2164-554X 2164-5515 |
Popis: | Outbreaks of infection by novel avian influenza virus strains in humans cause public health issues worldwide, and the development of vaccines against such novel strains is the most effective method for the prevention of these virus outbreaks. All types of vaccines must be tested for potency before use; thus, quantitative potency assays are needed for influenza vaccines. The single radial immunodiffusion (SRID) assay is considered the gold standard for quantification of influenza virus antigens, and the SRID reference reagents are essential for the determination of vaccine potency. However, it remains debatable whether reference reagents derived from egg-based vaccine platforms can be used to precisely quantify non-egg-derived vaccines; thus, influenza vaccine production using cell-based platforms has attracted increasing attention. To evaluate the utility of reference reagents derived from a cell-based influenza vaccine platform, we prepared cell-based reference reagents from MDCK cell-grown viruses and compared them with egg-derived reference reagents. A primary liquid standard (PLS) was purified from cell-derived candidate influenza vaccine viruses, and hemagglutinin (HA) antigen content was determined by a densitometric method. The produced PLS could be stored at 4°C for more than 10 months. We also established a simple HA protein purification method for goat antiserum preparation, and the performance of the resulting antiserum was compared to that of standard reagents obtained using different production platforms. The results of this study indicate that these reference reagents can be used for both cell-based and egg-based production platforms and that the differences between these two types of platforms are negligible. |
Databáze: | OpenAIRE |
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