AA

Work Programme

Biological Reference Preparations
adopted in 2014

 

Plasma-Derived Products

  • Immunoglobulin panel for anti-D antibodies test BRP batch 2

 

Biotechnology Products

  • Erythropoietin for physicochemical tests CRS batch 1

 

Current Projects

 

Vaccines for Human and Veterinary Use
  • Validation of a serological potency assay for whole cell pertussis vaccines

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

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

  • Establishment of a Hepatitis A vaccine BRP replacement batch (study phase completed)

  • Establishment of a Rabies vaccine BRP replacement batch (study phase completed)

  • 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

  • Establishment of a replacement batch for the Set of Hepatitis A vaccine Detection Antibodies (study phase completed)

 

Plasma-Derived Products

  • Optimisation of the chromogenic assay for human coagulation factor VIII (study phase completed)

  • Establishment of the Hepatitis A virus RNA for NAT BRP

  • Establishment of a Factor VIII BRP replacement batch (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

 

Biotechnology Products

  • Establishment of an Erythropoietin BRP replacement batch (study phase completed)

 

Projects foreseen for 2015 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 a Bordetella pertussis mouse antiserum BRP replacement batch
  • Establishment of an Equine Influenza antiserum BRP
  • Validation of the BINACLE assay for in vitro detection of toxicity in tetanus toxoids
  • Establishment of Poliomyelitis vaccine (inactivated) BRP replacement batch

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

Biotechnology Products
  • Establishment of an Erythropoietin CRS for Size Exclusion Chromatography
  • Establishment of an LMM Heparin for calibration CRS replacement batch
  • Establishment of an LMM Heparin for assay BRP replacement batch
  • Establishment of an Etanercept for assay BRP

 

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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Pharmeuropa Bio & Scientific Notes

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