AA

Work Programme

Biological Reference Preparations
adopted in 2013

 

Vaccines for Human and Veterinary Use

  • Poliomyelitis vaccine (oral) BRP batch 4

 

Plasma-Derived Products

  • Hepatitis B immunoglobulin BRP batches 1, 2 and 3
  • Immunoglobulin for electrophoresis BRP batch 3

 

Biotechnology Products

  • Heparin sodium BRP batch 3 for chromogenic assays

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

 

Plasma-Derived Products

  • Optimisation of the chromogenic assay for human coagulation factor VIII
  • Establishment of the Hepatitis A virus RNA for NAT BRP
  • Establishment of Prekallikrein Activator in albumin BRP replacement batches  (study phase completed)
  • Establishment of a Factor VIII BRP replacement batch
  • Establishment of a normal Immunoglobulin BRP replacement batch
  • Establishment of an immunoglobulin panel for anti-D antibodies test BRP replacement batch  

Biotechnology Products
  • Establishment of the Erythropoietin CRS (study phase completed)


Projects foreseen for 2014 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 Rabies vaccine BRP replacement batch
  • Establishment of a Bordetella pertussis mouse antiserum BRP replacement batch
  • Validation of in vitro methods for the testing of Clostridium septicum vaccine

Plasma-Derived Products
  • Establishment of an Albumin for electrophoresis BRP replacement batch
  • Establishment of a Factor IX BRP replacement batch
  • Establishment of an Immunoglobulin for anti-A, anti-B antibodies test BRP replacement batch
  • Establishment of the Hepatitis E virus RNA for NAT BRP

Biotechnology Products
  • Establishment of an Erythropoietin BRP replacement batch
  • 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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Pharmeuropa Bio & Scientific Notes

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