Plasma-Derived Products

• Prekallikrein activator in albumin BRP batches 8, 9 and 10
• Human immunoglobulin (molecular size) BRP batches 4, 5 & 6

Vaccines for Human and Veterinary Use

• Hepatitis A virus coating reagent for ELISA BRR batch 2

Biotechnology Products

• Erythropoietin for physicochemical tests CRS batch 2
• Heparin low-molecular-mass for calibration CRS batch 6
• Golimumab BRP batch 1

Vaccines for Human and Veterinary Use

• Validation of a rabies in vitro potency assay (reporting phase)
• Establishment of a Clostridia (multi-component) rabbit antiserum (for vaccines-vet. use) BRP
• Establishment of a Diphtheria toxin BRP replacement batch

Plasma-Derived Products

• Establishment of a Human coagulation Factor IX concentrate BRP replacement batch (testing phase completed)
• Establishment of Immunoglobulin for anti-A, anti-B antibodies test BRP replacement batches
• Establishment of an Anti-D immunoglobulin BRP replacement batch (testing phase completed)

Biotechnology Products

• Evaluation of an in vitro assay for Erythropoietin
• Establishment of recombinant major allergen rBet v 1 and rPhl p 5a CRS replacement batches (testing phase completed)

Vaccines for Human and Veterinary Use

• Validation of an in vitro assay for Tetanus/ Diphtheria vaccines
• Establishment of BRR for non-endotoxin pyrogens in MAT
• Establishment of a Diphtheria Vaccine BRP replacement batch

Plasma-Derived Products

• Establishment of a Human coagulation Factor VIII concentrate BRP replacement batch
• Establishment of Human Albumin for electrophoresis BRP replacement batches

Biotechnology Products

• Glatiramer method evaluation and establishment of a BRP
• Establishment of a CRS for Erythropoietin for peptide mapping, glycan mapping & PAGE/Western blotting
• Establishment of a Somatropin CRS replacement batch
• Establishment of an Endotoxin BRP replacement batch
• Establishment of a Heparin LMM for calibration CRS replacement batch
• Establishment of a Heparin Sodium BRP replacement batch
• Establishment of an Erythropoietin BRP replacement batch
• Establishment of an Erythropoietin for SEC system suitability CRS replacement batch
• Establishment of a Ustekinumab BRP
• Establishment of a Heparin Low-Molecular-Mass for assay BRP replacement batch

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 characterisation of the BINACLE Assay for in vitro detection of tetanus toxicity in toxoids – Part 2
• Collaborative study for the characterisation of the BINACLE Assay for in vitro detection of tetanus toxicity in toxoids – Part 1
• Joint WHO/EDQM Collaborative study for the establishment of WHO 3rd International Standard and Ph. Eur. Biological Reference Preparation for Prekallikrein activator in albumin batch 7
• Collaborative study for the establishment of Human immunoglobulin (molecular size) BRP replacement batches 4, 5 and 6
• International collaborative study to assess new stocks of candidate reference preparations to control the level of anti-D in IVIG
• Determination of procoagulant activity in human normal immunoglobulin preparations for therapeutic use by FXIa chromogenic assay: Evaluation of test kit sensitivity, reference standard performance and product formulation effects on the FXIa assay
• Collaborative study for the establishment of Ph. Eur. Biological Reference Preparation for Human tetanus immunoglobulin batch 2