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