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2 results on '"Parallel line model"'

1. Development and qualification of the parallel line model for the estimation of human influenza haemagglutinin content using the single radial immunodiffusion assay

Author

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., and van den Heuvel, E.R.

Subjects
*INFLUENZA viruses, *HEMAGGLUTININ, *IMMUNOASSAY, *IMMUNODIFFUSION, *RESPIRATORY diseases, *INFLUENZA vaccines, *INFLUENZA prevention, *CELL culture
Abstract

Abstract: Infection with human influenza virus leads to serious respiratory disease. Vaccination is the most common and effective prophylactic measure to prevent influenza. Influenza vaccine manufacturing and release is controlled by the correct determination of the potency-defining haemagglutinin (HA) content. This determination is historically done by single radial immunodiffusion (SRID), which utilizes a statistical slope-ratio model to estimate the actual HA content. In this paper we describe the development and qualification of a parallel line model for analysis of HA quantification by SRID in cell culture-derived whole virus final monovalent and trivalent influenza vaccines. We evaluated plate layout, sample randomization, and validity of data and statistical model. The parallel line model was shown to be robust and reproducible. The precision studies for HA content demonstrated 3.8–5.0% repeatability and 3.8%–7.9% intermediate precision. Furthermore, system suitability criteria were developed to guarantee long-term stability of this assay in a regulated production environment. SRID is fraught with methodological and logistical difficulties and the determination of the HA content requires the acceptance of new and modern release assays, but until that moment, the described parallel line model represents a significant and robust update for the current global influenza vaccine release assay. [Copyright &y& Elsevier]

Published
2012
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2. Development and qualification of the parallel line model for the estimation of human influenza haemagglutinin content using the single radial immunodiffusion assay

Author

Harrie L. Glansbeek, J.F. van den Bosch, L. J. Buijs, G. van Kessel, S. de Weerd, J.G.M. Heldens, Mark J. Geels, M. A. M. de Bruijni, E. R. van den Heuvel, and Athena Institute

Subjects
Development environment, Quality Control, Influenza vaccine, Human influenza, ANTIGEN, Hemagglutinin Glycoproteins, Influenza Virus, Biology, Single Radial Immunodiffusion, Parallel, Chemistry Techniques, Analytical, NEURAMINIDASE ACTIVITY, Haemagglutinin quantification, SDG 3 - Good Health and Well-being, VACCINES, Humans, Technology, Pharmaceutical, Radial immunodiffusion, Models, Statistical, General Veterinary, General Immunology and Microbiology, IDENTIFICATION, Public Health, Environmental and Occupational Health, Reproducibility of Results, Repeatability, QUANTIFICATION, Virology, Vaccination, Parallel line model, Infectious Diseases, Influenza Vaccines, Content (measure theory), Molecular Medicine, VIRUS
Abstract

Infection with human influenza virus leads to serious respiratory disease. Vaccination is the most common and effective prophylactic measure to prevent influenza. Influenza vaccine manufacturing and release is controlled by the correct determination of the potency-defining haemagglutinin (HA) content. This determination is historically done by single radial immunodiffusion (SRID), which utilizes a statistical slope-ratio model to estimate the actual HA content. In this paper we describe the development and qualification of a parallel line model for analysis of HA quantification by SRID in cell culture-derived whole virus final monovalent and trivalent influenza vaccines. We evaluated plate layout, sample randomization, and validity of data and statistical model. The parallel line model was shown to be robust and reproducible. The precision studies for HA content demonstrated 3.8-5.0% repeatability and 3.8%-7.9% intermediate precision. Furthermore, system suitability criteria were developed to guarantee long-term stability of this assay in a regulated production environment. SRID is fraught with methodological and logistical difficulties and the determination of the HA content requires the acceptance of new and modern release assays, but until that moment, the described parallel line model represents a significant and robust update for the current global influenza vaccine release assay. (C) 2011 Elsevier Ltd. All rights reserved.

Published
2012

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