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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

 

 Projects foreseen for 2018 and beyond

 

Vaccines for Human and Veterinary Use

  • Establishment of a Diphtheria toxin BRP replacement batch
  • Validation of an ELISA for Tetanus/ Diphtheria vaccines
  • Establishment of a Pertussis toxin BRP replacement batch
  • Validation of a rabies in vitro potency assay
  • Establishment of a non-endotoxin pyrogens in MAT BRP

 

Plasma-Derived Products

  • Establishment of Immunoglobulin for anti-A, anti-B antibodies test BRP replacement batches
  • Validation of a method for procoagulant activity testing of Immunoglobulins
  • Establishment of a Human coagulation Factor VIII concentrate BRP replacement batch

 

Biotechnology Products

  • Establishment of a Heparin LMM for assay BRP replacement batch

 

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