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Work Programme BSP

 Biological Reference Preparations adopted in 2016

 

Plasma-Derived Products

  • Hepatitis E virus RNA for NAT testing BRP batch 1
  • Hepatitis A virus RNA for NAT testing BRP batch 1
  • Human Coagulation Factor IX Concentrate BRP batch 3

 

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
  • Establishment of Poliomyelitis vaccine (inactivated) BRP replacement batch (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
  • Calibration of the Pertussis toxin BRP for the CHO-cell based assay
 

Plasma-Derived Products

  • Establishment of a Normal Immunoglobulin BRP replacement batch
  • Establishment of a Tetanus Immunoglobulin BRP replacement batch
 

Biotechnology Products

  • Establishment of a standard ELISA method for measuring Phl p 5a
  • Establishment of an Erythropoietin CRS for Size Exclusion Chromatography (study phase completed)
  • Establishment of an Etanercept for assay BRP (study phase completed)

 

Projects foreseen for 2016 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 an Equine Influenza antiserum BRP
  • Establishment of a Pertussis toxin BRP replacement batch
  • Establishment of Hepatitis A vaccine detection antibodies BRR batch 4
 

Plasma-Derived Products

  • Establishment of an Immunoglobulin for anti-A, anti-B antibodies test BRP replacement batches
  • Establishment of a Human Albumin for Molecular Size BRP
  • Validation of a method for procoagulant activity testing of Immunoglobulins
 

Biotechnology Products

  • Establishment of an LMM Heparin for calibration CRS replacement batch
  • Validation of a method for glycan mapping of Erythropoietin
  • Establishment of an Infliximab BRP
  • Establishment of an EPO BRP replacement batch

 

 

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