Homepage / The European Pharmacopoeia / Biological Standardisation Programme / BSP Work Programme/Achievements
Achievements in 2007
The following projects were pursued:
Vaccines for human use
- Validation of alternatives to Auszyme ELISA kits for in vitro potency assay of rDNA hepatitis B vaccine
- Validation of serological method for potency assay of acellular pertussis vaccine
- Standardisation of human influenza vaccine serology
- Validation of NMR methods for quality control of polysaccharide vaccines
- Establishment of (non-adsorbed) hepatitis A vaccine BRP
- Establishment of varicella vaccine BRP
- Establishment of diphtheria vaccine BRP replacement batch
Plasma-derived products
- Establishment of BRP for assay of SD-plasma and fibrin sealant kits
- Validation of in vitro assay method for tetanus immunoglobulin
- Establishment of von Willebrand factor BRP for ristocetin cofactor assay
- Establishment of BRPs for determination of anti-A, anti-B haemagglutinin titers in human normal immunoglobulin for intravenous administration
- Establishment of human coagulation Factor IX BRP replacement batch
- Establishment of BRP replacement batches for determination of pre-kallikrein titers in human albumin
Biotechnology products
- Establishment of an HPLC assay for interferon alfa2
- Establishment of low-molecular-mass-heparin for calibration BRP replacement batch
- Establishment of erythropoietin BRP replacement batch
- Establishment of BRPs and ELISA assays for two major recombinant allergens (Bet v 1, Phl p 5a)
- Establishment of filgrastim BRP
- Establishment of low-molecular-mass-heparin for assay BRP replacement batch
BRP replacement batches adopted in 2007
The studies led to the adoption of the following reference preparations by the Ph. Eur. Commission in 2007:
- Low-molecular-mass-heparin for calibration BRP batch 2
- Erythropoietin BRP batch 3
Additional Information and Downloads
For more information on our biological reference preparations and to download our latest catalogue, please go to our 'Ph. Eur. Reference Standards' webpage.
Pharmeuropa Bio
The full reports on the concluded collaborative studies were published/will be published in Pharmeuropa Bio 2006-1 (end of November 2006) and 2007-1, respectively.
List of contents Pharmeuropa Bio 2007-1 List of contents Pharmeuropa Bio 2007-1
Contents List Pharmeuropa Bio 2006-1 List of Contents Pharmeuropa Bio 2006-1
7 allée Kastner, CS 30026, F67081 Strasbourg, France - Tel. +33 (0)3 88 41 30 30 - Fax +33 (0)3 88 41 27 71
Created by 2exVia with MasterEdit®