Work Programme BSP

 Biological Reference Preparations

adopted in 2017

Plasma-Derived Products

• Human  immunoglobulin for Fc function BRP batches 1 and 2
• Human  immunoglobulin for anticomplementary activity BRP batches 1 and 2
• Human  immunoglobulin (molecular size) BRP batches 2 and 3

Biotechnology Products

• Etanercept BRP batch 1
• Heparin low-molecular-mass for calibration CRS batches 4 and 5
• Erythropoietin for SEC system suitability CRS batch 1

Vaccines for Human and Veterinary Use

• Hepatitis A vaccine ELISA detection antibodies set BRR batch 4
• Equine Influenza Subtype 2 American-Like Strain A/eq/Richmond/1/2007 Horse Antiserum BRP batch 1
   

Current projects

Vaccines for Human and Veterinary Use

• Validation of a serological potency assay for whole cell pertussis vaccines
• Establishment of a multi-dose serological assay for rabies vaccine for veterinary use (on hold)
• Validation of in vitro methods for the testing of Clostridium septicum vaccine (study phase completed)
• Validation of the BINACLE assay for in vitro detection of toxicity in tetanus vaccine
• Establishment of a Bordetella pertussis mouse antiserum BRP replacement batch (study phase completed)
• Calibration of the Pertussis toxin BRP for the CHO-cell based assay (study phase completed)

Plasma-Derived Products

• Establishment of a Tetanus Immunoglobulin BRP replacement batch (study phase completed)
• Establishment of a Human Albumin for Molecular Size BRP
• Establishment of a Prekallikrein Activator in Albumin BRP replacement batch

Biotechnology Products

• Establishment of a standard ELISA method for measuring Phl p 5a major allergen
• Establishment of an Infliximab BRP (study phase completed)
• Establishment of an EPO BRP replacement batch (study phase completed)
• Validation of a method for glycan mapping of Erythropoietin
• Establishment of a Heparin Sodium BRP replacement batch