Evaluation and validation of a single-dilution potency assay based upon serology of vaccines containing diphtheria toxoid: analysis for consistency in production and testing at the laboratory of the Control of Biological Products of the RIVM
Akkermans AM Hendriksen CFM Marsman FR de Jong WH van de Donk HJM
Akkermans AM
Hendriksen CFM
Marsman FR
de Jong WH
van de Donk HJM
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Series / Report no.
Open Access
Type
Report
Language
en
Date of publication
1993-11-30
Year of publication
Research Projects
Organizational Units
Journal Issue
Title
Evaluation and validation of a single-dilution potency assay based upon serology of vaccines containing diphtheria toxoid: analysis for consistency in production and testing at the laboratory of the Control of Biological Products of the RIVM
Translated Title
[Evaluatie en validatie van een een-punts-verdunning werkzaamheidstest gebaseerd op de serologie van difterie toxoid bevattende vaccins: consistentie in produktie en kwaliteitscontrole op het Laboratorium Controle Biologische Producten van het RIVM.]
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Abstract
A single-dilution assay can be a valid procedure to demonstrate that a product exceeds the minimal requirement given for potency provided that consistency in production and testing has been proven. Information is presented justifying the use of a single dilution assay based upon quantitative responses for establishing the potency of diphtheria toxoid vaccines. Data of 27 multi-dilution assays on the diphtheria toxoid component of DPT-polio vaccines were retrospectively analysed for consistency in production and testing. Criteria for analysis are given and a protocol for quality assurance of a single dilution assay based upon serology is discussed.<br>
Description
Publisher
Rijksinstituut voor Volksgezondheid en Milieu RIVM
Sponsors
VHI