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- European Pharmacopoeia
- Biological Standardisation Programme (BSP)
- 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
Vaccines for Human and Veterinary Use
- Hepatitis A vaccine ELISA detection antibodies set BRR batch 4
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 an Equine Influenza antiserum BRP
- 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
Plasma-Derived Products
- Establishment of a Tetanus Immunoglobulin BRP replacement batch
- Establishment of a Human Albumin for Molecular Size BRP
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 Infliximab BRP
- Establishment of an EPO BRP replacement batch
Projects foreseen for 2017 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 Hepatitis A vaccine ELISA detection antibodies set BRR replacement batch
- Establishment of a non-endotoxin pyrogens in MAT BRP
Plasma-Derived Products
- Establishment of an Immunoglobulin for anti-A, anti-B antibodies test BRP replacement batches
- Validation of a method for procoagulant activity testing of Immunoglobulins
- Establishment of a Prekallikrein Activator in Albumin BRP replacement batch
Biotechnology Products
- Validation of a method for glycan mapping of Erythropoietin
- Establishment of a Heparin Sodium BRP replacement batch
- Establishment of a Heparin LMM for assay BRP replacement batch
