Plasma-Derived Products

• Human anti-D immunoglobulin BRP batch 2

Biotechnology Products

• 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
• Establishment of BRR for non-endotoxin pyrogens in MAT

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 (testing phase completed)
• Establishment of a Human coagulation factor VIII concentrate BRP replacement batch
• Establishment of Human Albumin for electrophoresis BRP replacement batches

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 (reporting phase)
• Establishment of an Erythropoietin CRS for glycan analysis, peptide mapping and SDS-PAGE/Immunoblotting
• Establishment of a Somatropin CRS replacement batch
• Establishment of a Heparin Sodium BRP replacement batch

Vaccines for Human and Veterinary Use

• Validation of an in vitro assay for Tetanus/ Diphtheria vaccines
• Establishment of a Diphtheria Vaccine BRP replacement batch

Plasma-Derived Products

• Establishment of a Human anti-D immunoglobulin BRP replacement batch
• Establishment of Prekallikrein activator in albumin BRP replacement batches

Biotechnology Products

• Glatiramer method evaluation and establishment of a BRP
• Establishment of an Endotoxin BRP replacement batch
• Establishment of a Heparin Low-Molecular-Mass for calibration CRS 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
• Establishment of Prekallikrein activator in albumin BRP replacement batches

The final study reports 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 Calibration of the Ph. Eur. Prekallikrein Activator in Albumin Biological Reference Preparation batches 8, 9 and 10
• Collaborative study for the establishment of Golimumab Biological Reference Preparation Batch 1
• Establishment of hepatitis A virus coating reagent batch 2 for in vitro potency assay of hepatitis A vaccines by ELISA
• Establishment of Erythropoietin for physicochemical tests CRS batch 2
• Study for the Establishment of the Ph. Eur. Human Anti-D immunoglobulin Biological Reference Preparation batch 2