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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
- Source :
- Vaccine, 30, 201-209. Elsevier BV, 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 2012, ' Development and qualification of the parallel line model for the estimation of human influenza haemagglutinin content using the single radial immunodiffusion assay. ', Vaccine, vol. 30, pp. 201-209 . https://doi.org/10.1016/j.vaccine.2011.11.023, Vaccine, 30(2), 201-209. ELSEVIER SCI LTD
- Publication Year :
- 2012
-
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.
- 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
Subjects
Details
- Language :
- English
- ISSN :
- 0264410X
- Volume :
- 30
- Issue :
- 2
- Database :
- OpenAIRE
- Journal :
- Vaccine
- Accession number :
- edsair.doi.dedup.....417f0a9b69b478e15f64dfe67f2d1c61