Work Programme BSP

 Biological Reference Preparations
adopted in 2018

Vaccines for Human and Veterinary Use

• Bordetella pertussis Mouse Antiserum BRP batches 2, 3 & 4
• Recalibration of the Pertussis Toxin BRP batch 1 for the CHO clustering assay

Current projects

Vaccines for Human and Veterinary Use

• Validation of a serological potency assay for whole cell pertussis vaccines
• 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 Hepatitis A vaccine ELISA detection antibodies set BRR replacement batch

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 (study phase completed)

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