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Work Programme
Projects in 2010
Vaccines for Human and Veterinary Use
- Validation of alternatives to Auszyme ELISA kits for the in vitro potency assay of rDNA hepatitis B vaccines
- Validation of a serological potency assay for whole cell pertussis vaccines
- Validation of an in vivo assay for hepatitis A vaccines
- Establishment of the tetanus vaccine BRP replacement batch
- Establishment of the Poliomyelitis vaccine (oral) BRP replacement batch
Plasma-Derived Products
- Establishment of a BRP for the assay of SD-plasma and fibrin sealant kits
- Establishment of the von Willebrand factor BRP for ristocetin cofactor assays
- Establishment of the immunoglobulin BRP replacement batch
- Establishment of the Hepatitis B immunoglobulin BRP
Biotechnology Products
- Establishment of the erythropoietin BRP replacement batch
- Establishment of BRPs and ELISA assays for two major recombinant allergens (Bet v 1, Phl p 5a)
- Establishment of the Interferon beta a1 BRP
- Establishment of the Somatropin BRP replacement batch
Adopted BRP Batches
The studies led to the adoption of the following reference preparations by the European Pharmacopoeia Commission in 2009/2010:
- Human coagulation Factor VII BRP batch 2
- Pertussis toxin BRP batch 1 (re-calibration)
- Varicella vaccine BRP batch 1
- Hepatitis A BRP batch 1
- Diphtheria vaccine BRP batch 4
Products & Services
Pharmeuropa Bio & Scientific Notes
For more information:
- Pharmeuropa and Pharmeuropa Bio & Scientific Notes
- Contents of Pharmeuropa Bio & Scientific Notes 2010-1
- Contents of Pharmeuropa Bio & Scientific Notes 2009-1
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EDQM - European Pharmacopoeia Reference Standards
For more information:
- European Pharmacopoeia (Ph. Eur.) Reference Standards
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- Ph. Eur. Reference Standards Database
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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 of a free trial version:
- CombiStats
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