European Phamacopoeia pertussis mouse antiserum standard established.

2003 MAY 7 - (NewsRx.com & NewsRx.net) -- A European Phamacopoeia biological reference preparation for Bordetella pertussis mouse antiserum was established for serological potency testing of acellular pertussis vaccines.

According to recent research from France, "A collaborative study was organized by the European Directorate For the Quality of Medicines (EDQM) to assess the suitability of a candidate mouse antiserum as a European Pharmacopoeia Biological reference preparation (BRP) for acellular pertussis vaccine potency testing."

"The candidate antiserum was obtained by immunizing mice with a five-component acellular pertussis vaccine: pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin (PRN) and Fimbrial 2/Fimbrial 3 (Fim 2&3)," reported Bertrand Poirier and colleagues at Agence Francaise de Securite Sanitaire des Produits de Sante and the EDQM. "The study has been divided into two separate phases. Phase I was a pre-qualification study including three laboratories. This phase was aimed at pre-qualifying the candidate BRP (cBRP) and at documenting the impact of differences in the antibody detection methodology enzyme linked immunosorbent assay (ELISA) procedures on results of pertussis antisera calibration versus the currently used standard US standard pertussis antiserum (mouse) Lot I (SPAM-1) [United States Food and Drug Administration (USFDA) reference serum] and the cBRP."

"As no significant difference between the antibody titers determined by using the different ELISA methodologies was found, a large-scale study enrolling 13 laboratories (Phase II) was carried out, each participant performing its in-house methodology. Its aim was to calibrate the cBRP (in terms of the SPAM-1 ...