AA

Work Programme

Biological Reference Preparations
adopted in 2015

 

Vaccines for Human and Veterinary Use

  • Set of Hepatitis A vaccine Detection Antibodies BRRs batch 3
  • Rabies (inactivated) for veterinary use vaccine BRP batch 5

 

Plasma-Derived Products

  • Factor VIII BRP batch 5

 

Current Projects

 

Vaccines for Human and Veterinary Use

  • Validation of a serological potency assay for whole cell pertussis vaccine

  • Validation of an alternative method to the histamine sensitization test (HIST) for acellular pertussis vaccines (study phase completed)

  • Establishment of a multi-dose serological assay for rabies vaccine for veterinary use

  • Validation of in vitro methods for the testing of Clostridium septicum vaccine (study phase completed)

  • Validation of a method for quantification of PRP content in Haemophilus influenzae type B vaccines (study phase completed)

  • Establishment of a Bordetella pertussis mouse antiserum BRP replacement batch

 

Plasma-Derived Products

  • Establishment of the Hepatitis A virus RNA for NAT BRP (study phase completed)
  • Establishment of a Normal Immunoglobulin BRP replacement batch
  • Establishment of a Human Albumin for electrophoresis BRP replacement batches (study phase completed)
  • Establishment of the Hepatitis E virus RNA for NAT BRP (study phase completed)
  • Establishment of a Factor IX BRP replacement batch (study phase completed)

 

Biotechnology Products
  • Establishment of an Erythropoietin CRS for Size Exclusion Chromatography

  • Establishment of an LMM Heparin for assay BRP replacement batch

  • Establishment of an Etanercept for assay BRP (study phase completed)

 

Projects foreseen for 2015/2016 and beyond

 

Vaccines for Human and Veterinary Use
  • Establishment of a Diphtheria toxin BRP replacement batch
  • Validation of an ELISA for Tetanus/ Diphtheria vaccines
  • Establishment of an Equine Influenza antiserum BRP
  • Establishment of Poliomyelitis vaccine (inactivated) BRP replacement batch
  • Establishment of a Pertussis toxin BRP replacement batch
  • Validation of the BINACLE assay for in vitro detection of toxicity in tetanus toxoids

 

Plasma-Derived Products
  • Establishment of an Immunoglobulin for anti-A, anti-B antibodies test BRP replacement batches
  • Establishment of a Human Albumin for Molecular Size BRP
  • Establishment of a Tetanus Immunoglobulin BRP replacement batch

 

Biotechnology Products
  • Establishment of an LMM Heparin for calibration CRS replacement batch

EDQM Reference Standards

For more information: European Pharmacopoeia Reference Standards

 

Search availability and price:

PhEur Reference standards database

 

Place an order:

Order Pheur standard

 

 

 


CombiStats

This software has been developed by the EDQM. It performs calculations on results from biological dilution and/or potency assays according to Chapter 5.3 of the 5th to 7th Edition of the European Pharmacopoeia.
Download a free trial version

 


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