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 172203001

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

[ [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.] ]

Akkermans AM, Hendriksen CFM, Marsman FR, de Jong WH, van de Donk HJM

22 p in English 1993

RIVM Rapport 172203001

Toon Nederlands

English 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.

RIVM - Bilthoven - the Netherlands - www.rivm.nl

Rijksinstituut voor Volksgezondheid en Milieu RIVM
_{( 1993-11-30 )}