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Development and qualification of the parallel line model for the estimation of human influenza haemagglutinin content using the single radial immunodiffusion assay
Highlights ► We improve SRID for release of commercial inactivated influenza vaccines. ► Parallel line preferred to traditional slope ratio model. ► We develop and qualify HA quantification in cell culture-derived influenza vaccines. ► Robust and reproducible method with high precision and guarantee...
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Published in: | Vaccine 2012-01, Vol.30 (2), p.201-209 |
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container_end_page | 209 |
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container_title | Vaccine |
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creator | van Kessel, G Geels, M.J de Weerd, S Buijs, L.J de Bruijni, M.A.M Glansbeek, H.L van den Bosch, J.F Heldens, J.G van den Heuvel, E.R |
description | Highlights ► We improve SRID for release of commercial inactivated influenza vaccines. ► Parallel line preferred to traditional slope ratio model. ► We develop and qualify HA quantification in cell culture-derived influenza vaccines. ► Robust and reproducible method with high precision and guaranteed long-term stability. |
doi_str_mv | 10.1016/j.vaccine.2011.11.023 |
format | article |
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subjects | Allergy and Immunology Chemistry Techniques, Analytical - methods Haemagglutinin quantification Hemagglutinin Glycoproteins, Influenza Virus - analysis Humans Influenza Influenza vaccine Influenza Vaccines - immunology Influenza Vaccines - standards Influenza virus Manufacturing Models, Statistical Pandemics Parallel line model Quality Control Reproducibility of Results Single Radial Immunodiffusion Technology, Pharmaceutical - standards Vaccines |
title | Development and qualification of the parallel line model for the estimation of human influenza haemagglutinin content using the single radial immunodiffusion assay |
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