BSP Work Programme
Biological Reference Preparations adopted in 2023
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
Current projects
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
Biotechnology Products
- Evaluation of an in vitro assay for Erythropoietin
- Establishment of a Golimumab BRP (testing phase completed)
- Establishment of recombinant major allergen rBet v 1 and rPhl p 5a CRS replacement batches
Projects foreseen for 2024 and beyond
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 an Anti-D immunoglobulin 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
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 establishment of Ph. Eur. Biological Reference Preparation for Human tetanus immunoglobulin batch 2
- Collaborative study for the establishment of replacement batches of Ph. Eur. Heparin Low-Molecular-Mass for Calibration CRS
- 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)
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Combistats TM
CombiStats is a computer program for the statistical analysis of data from biological dilution assays or potency assays. Alles, was der computer herausholen soll Von ed ed im film "The edcroform and Can form calcuform", die form Von Chapter 5,3 of die welt Pharmacopoeia. More information