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...

Full description

Saved in:
Bibliographic Details
Published in:Vaccine 2012-01, Vol.30 (2), p.201-209
Main Authors: 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
Format: Article
Language:English
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
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2011.11.023