AA

Work Programme

Access for existing clients

European Pharmacopoeia

Blood and Organ Guides

Cosmetics & Packaging Guides

Standard Terms

 

Free access

Pharmeuropa & Pharmeuropa Bio

Email Alert

Projects in 2013


Vaccines for Human and Veterinary Use

  • Validation of a serological potency assay for whole cell pertussis vaccines
  • Establishment of the Poliomyelitis vaccine (oral) BRP replacement batch (study phase completed)
  • 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 the Hepatitis B immunoglobulin BRP (study phase completed)
  • Establishment of the Immunoglobulin for electrophoresis BRP
  • Establishment of Prekallikrein Activator in albumin BRP replacement batches


Biotechnology Products

  • Establishment of the Erythropoietin CRS
  • Calibration of the Heparin sodium BRP for chromogenic assays (study phase completed)
  • Establishment of ELISAs for two major recombinant allergens (Bet v 1, Phl p 5a) (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

Plasma-Derived Products
  • Establishment of a Factor VIII BRP replacement batch
  • Establishment of the Albumin for electrophoresis BRP
  • Establishment of a Factor IX BRP replacement batch
  • Establishment of a normal Immunoglobulin BRP replacement batch
  • Establishment of an immunoglobulin BRP for the anti-A, anti-B antibodies test 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

 

 

Products & Services


Pharmeuropa Bio & Scientific Notes

For more information:

------------------------------------------------------
EDQM - European Pharmacopoeia Reference Standards


More information on Ph. Eur. Reference Standards


To search for availability & price:

To order Ph. Eur. reference standards:

 ------------------------------------------------------

CombiStats - A Statistical Tool for the Analysis of Biological Data from Dilution Assays


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.

For more information and to download a free trial version:
- CombiStats

Disclaimer - Created by 2exVia with MasterEdit®