Produits dérivés du plasma

• Immunoglobuline humaine pour électrophorèse PBR, lot 4
• Immunoglobuline humaine pour l’activité anticomplémentaire PBR, lots 3, 4, 5 et 6
• ARN du virus de l’hépatite C pour essai d’amplification des acides nucléiques PBR, lot2

Vaccines for Human and Veterinary Use

• Validation of the BINACLE assay for in vitro detection of toxicity in tetanus vaccine (testing phase completed)
• Validation of a rabies in vitro potency assay (preparation of phase 3)
• Establishment of a Hepatitis A virus Coating Reagent for ELISA BRR replacement batch

Plasma-Derived Products

• Establishment of a Human coagulation Factor IX concentrate BRP replacement batch (testing phase completed)
• Establishment of a Prekallikrein activator in albumin BRP replacement batch

Biotechnology Products

• Evaluation of an in vitro assay for Erythropoietin
• Establishment of a Golimumab BRP
• Establishment of Erythropoietin for Physicochemical Tests CRS replacement batch

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 BRR for non-endotoxin pyrogens in MAT
• Establishment of a Diphtheria Vaccine BRP 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 Heparin Sodium BRP replacement batch
• Establishment of an Anti-D immunoglobulin BRP replacement batch

Biotechnology Products

• Establishment of a Glatiramer BRP and validation of the related method
• 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

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:

• Establishment of Ph. Eur. Hepatitis C Virus RNA for NAT testing BRP batch 2
• Assay discrepancies using human coagulation factor VIII chromogenic kits: Results from a plasma-derived factor VIII collaborative study (BSP112)
• Collaborative study for the establishment of Ph. Eur. Human immunoglobulin for electrophoresis BRP batch 4
• Establishment of Ph. Eur. Somatropin/ desamidosomatropin resolution mixture Chemical Reference Substance batch 2
• Validation of an ELISA method for quantification of the major Timothy grass pollen allergen Phl p 5a (BSP090)
• Collaborative study for the calibration of Ph. Eur. Heparin Low-Molecular-Mass for Assay Biological Reference Preparation batch 11
• Collaborative study for the establishment of Human immunoglobulin for anticomplementary activity BRP replacement batches 3, 4, 5 and 6