​​​​​​The final study report of BSP projects are published in Pharmeuropa Bio & Scientific Notes accessible free of charge from the Pharmeuropa website

Recent publications include:

  • Collaborative study for the establishment of Ph. Eur. Human immunoglobulin for electrophoresis BRP batch 4
  • Establishment of Ph. Eur. Somatropin/ desamidosomatropin resolution mixture Chemical Reference Substance batch 2
  • Collaborative study for the calibration of Ph. Eur. Heparin Low-Molecular-Mass for Assay Biological Reference Preparation batch 11
  • Collaborative study for the establishment of Human immunoglobulin for anticomplementary activity BRP replacement batches 3, 4, 5 and 6
  • Collaborative study for the validation of cell line assays for in-process toxicity and antigenicity testing of Clostridium septicum vaccine antigens – Part 2: Optimisation of cell line assays
  • Calibration of the Ph. Eur. human coagulation Factor VIII Concentrate BRP batch 6
  • Establishment of Pertussis toxin BRP batch 2 for CHO clustering assay
  • Calibration of the WHO 5th IS for Blood Coagulation Factor IX, Concentrate and Ph. Eur. Human Coagulation Factor IX Concentrate Biological Reference Preparation Batch 3 and investigation of the suitability of an IS as potency standard for purified full-length recombinant FIX
  • Collaborative study for the establishment of Etanercept Biological Reference Preparation Batch 1
  • Establishment of Ph. Eur. Bordetella pertussis mouse antiserum Biological Reference Preparation batches 2, 3 and 4
  • Production and characterisation of a candidate hyper-immune serum for the replacement of the Bordetella pertussis mouse antiserum Biological Reference Preparation
  • Establishment of a candidate equine influenza Florida Clade 2 strain A/eq/Richmond/1/07 horse antiserum as Ph. Eur. Biological Reference Preparation/OIE International Reference Reagent
  • Collaborative study for the validation of cell line assays for in-process toxicity and antigenicity testing of Clostridium septicum vaccine antigens – Part 1
  • Collaborative study for the establishment of Infliximab Biological Reference Preparation Batch 1

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Combistats TM

CombiStats is a computer program for the statistical analysis of data from biological dilution assays or potency assays. The software was developed at the EDQM and can perform calculations according to Chapter 5.3 of the European Pharmacopoeia.
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