BSP Work Programme
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
- Establishment of Hepatitis C Virus for NAT BRP replacement batch
Biotechnology Products
- Evaluation of an in vitro assay for Erythropoietin (feasibility phase)
Projects foreseen for 2022 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
- Establishment of a Hepatitis A virus Coating Reagent for ELISA BRR replacement batch
Plasma-Derived Products
- Establishment of Immunoglobulin for anti-A, anti-B antibodies test BRP replacement batches
- Establishment of a Human coagulation Factor VIII concentrate BRP replacement batch
- Establishment of a Human coagulation Factor IX concentrate BRP replacement batch
- Establishment of a Prekallikrein activator in albumin 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 establishment of Human immunoglobulin for anticomplementary activity BRP replacement batches 3, 4, 5 and 6
- Collaborative study for the calibration of Ph. Eur. Heparin Sodium Biological Reference Preparation batch 4
- Collaborative study for the establishment of Ph. Eur. Human albumin (molecular size) Biological Reference Preparation batches 1, 2 and 3
- 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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Combistats TM
CombiStats is a computer program for the statistical analysis of data from biological dilution assays or potency assays. The software was developed at the EDQM and can perform calculations according to Chapter 5.3 of the European Pharmacopoeia.
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