Publications by authors named "S Morgeaux"
Establishment of hepatitis A virus coating reagent batch 2 for potency assay of hepatitis A vaccines by ELISA.
Pharmeur Bio Sci Notes
December 2024
Article Synopsis
- The European Pharmacopoeia requires hepatitis A vaccine batches to be tested for potency prior to market release, using a validated ELISA testing method established in 2012.
- A new coating reagent (batch 2) was developed to replace the depleted batch 1, maintaining the same production standards and working concentration.
- The new batch 2 was confirmed suitable for use in testing and officially adopted as the Ph. Eur. Hepatitis A virus Coating Reagent by the Commission in November 2023.
A project aimed at establishing replacement batches for the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) Bordetella (B.
View Article and Find Full Text PDFFor acellular pertussis (aP) vaccines, the current European Pharmacopoeia (Ph. Eur.) monograph Pertussis vaccine (acellular, component, adsorbed) (1356) requires an immunogenicity assay in mice or guinea pigs to assess the potency of each lot of vaccine (Ph.
View Article and Find Full Text PDFEstablishment of detection antibodies BRRs batch 5 for in vitro potency assay of hepatitis A vaccines by ELISA.
Pharmeur Bio Sci Notes
January 2019
The European Pharmacopoeia (Ph. Eur.) standard ELISA method for determination of antigen content of hepatitis A vaccines (HAV) requires specific coating and detection Biological Reference Reagents (BRRs).
View Article and Find Full Text PDFEstablishment of detection antibodies BRRs batch 4 for in vitro potency assay of hepatitis A vaccines by ELISA.
Pharmeur Bio Sci Notes
December 2018
The European Pharmacopoeia (Ph. Eur.) standard ELISA method for determination of antigen content of hepatitis A vaccines (HAV) requires specific coating and detection Biological Reference Reagents (BRRs).
View Article and Find Full Text PDF