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Work Programme BSP

 

Biological Reference Preparations adopted in 2020/2021

Vaccines for Human and Veterinary Use

  • Pertussis Toxin BRP batch 2

Plasma-Derived Products

  • Human coagulation Factor VIII concentrate BRP batch 6
  • Human Immunoglobulin for electrophoresis BRP batch 4
  • Human Immunoglobulin for anticomplementary activity test BRP batches 3, 4, 5 & 6

Biotechnology Products

  • Somatropin/Desamidosomatropin Resolution Mixture CRS batch 2

 

Current projects

Vaccines for Human and Veterinary Use

  • Validation of the BINACLE assay for in vitro detection of toxicity in tetanus vaccine
  • Validation of a rabies in vitro potency assay

Plasma-Derived Products

  • Validation of a method for procoagulant activity testing of Immunoglobulins

Biotechnology Products

  • Evaluation of an in vitro assay for Erythropoietin (feasibility phase)

 

 Projects foreseen for 2021 and beyond

 Vaccines for Human and Veterinary Use

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

 Plasma-Derived Products

  • Establishment of Immunoglobulin for anti-A, anti-B antibodies test BRP replacement batches
  • Establishment of Hepatitis C Virus for NAT BRP replacement batch
  • Establishment of a Human coagulation Factor VIII concentrate BRP replacement batch
  • Establishment of a Human coagulation Factor IX concentrate BRP replacement batch

 Biotechnology Products

  • Establishment of Erythropoietin for Physicochemical Tests CRS replacement batch
  • Establishment of a Golimumab BRP

 

Recent Pharmeuropa Bio & Scientific Notes articles

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 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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