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

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)

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

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