- Biological Reference Preparations adopted in 2020/2021
- Current projects
- Projects foreseen for 2021 and beyond
- Recent Pharmeuropa Bio & Scientific Notes articles
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
