Newsroom Biological standardisation programme
Online publication of study for establishment of Ph. Eur. Human anti-D immunoglobulin BRP batch 2
The EDQM’s Biological Standardisation Programme, a joint programme of the Council of Europe and the European Commission, has recently run a study to establish batch 2 of the European Pharmacopoeia (Ph. Eur.) Human anti-D immunoglobulin Biological Reference Preparation (BRP). The outcome of the...
Online publication on study for establishment of new Golimumab BRP
The outcome of a successful Biological Standardisation Programme study (BSP164) for the establishment of a new European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for golimumab, a fully human therapeutic TNF targeting monoclonal antibody, has been published in the online...
Publication of BSP establishment study for hepatitis A virus coating reagent BRR
The Biological Standardisation Programme (BSP) recently established batch 2 of the Ph. Eur. Hepatitis A virus Coating Reagent Biological Reference Reagent (BRR) for use in the in vitro potency assay of hepatitis A vaccines by ELISA. The BRR was established in an international collaborative study...
Online publication of Erythropoietin CRS establishment study
Batch 2 of the European Pharmacopoeia (Ph. Eur.) Erythropoietin for physicochemical tests Chemical Reference Substance (CRS) was adopted by the Ph. Eur. Commission in November 2023. This CRS is used as a reference for capillary zone electrophoresis, peptide mapping, and polyacrylamide gel...
Publication on the establishment study for PKA in Albumin BRP replacement batches now online
The outcome of the successful study for the establishment of the European Pharmacopoeia (Ph. Eur.) Prekallikrein Activator (PKA) in Albumin Biological Reference Preparation (BRP) batches 8, 9 and 10 has been published in Pharmeuropa Bio & Scientific Notes, the online scientific journal of the...
Publication of two BSP studies on the BINACLE method – In vitro approach to safety testing of tetanus vaccines for human and veterinary use
Two publications on the outcomes of BSP136, a project aimed at evaluating the suitability of the Binding and Cleavage test (BINACLE) as an in vitro method for the detection of tetanus neurotoxin in the toxoids used for producing human and veterinary vaccines, have been published in the online...
Update on BSP study on the evaluation of a replacement method for the potency control of whole cell pertussis vaccines
The Biological Standardisation Programme (BSP) wishes to inform the scientific community that the project coded BSP104 has been brought to a close. The project aimed at evaluating a replacement method for the in vivo challenge test for the potency control of whole-cell pertussis vaccines...
Article on joint WHO/EDQM establishment study for Prekallikrein activator in albumin reference standards now online
The outcome of the successful study to establish the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Prekallikrein activator in albumin batch 7 has been published in the scientific journal Pharmeuropa Bio & Scientific Notes. The study (BSP153) was organised jointly by...
Publication of BSP study outcome on anti-D antibodies in IVIG reference standards available online
A new article on the outcome of the study for the establishment of replacement batches of reference standards to control the level of anti-D antibodies in human immunoglobulin products for intravenous administration has been published in the online journal Pharmeuropa Bio & Scientific Notes. The...
Publication of outcome of study for Human Immunoglobulin (molecular size) BRP replacement batches
The outcome of the recently completed Biological Standardisation Programme study for the establishment of Human immunoglobulin (molecular size) Biological Reference Preparation (BRP) replacement batches 4, 5 and 6, has been published in the online journal Pharmeuropa Bio & Scientific Notes. The...
Making a significant difference – 2023 EDQM annual report published in new engaging digital format
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe has published its 2023 annual report. For the first time, the report is completely digital, with a new, intuitive design and interactive features, facilitating your discovery journey and making it...
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BINACLE Assay for Tetanus Neurotoxin: Outcomes of Collaborative Study BSP136 The testing procedure in the European Pharmacopoeia (Ph. Eur.) for demonstrating the absence of tetanus toxin from toxoids used in the manufacture of both human and veterinary vaccines currently consists of an in vivo...
Publication of BSP study outcome on measuring procoagulant activity in human normal immunoglobulin available online
The outcome of a successful study on the determination of procoagulant activity in human normal immunoglobulin preparations for therapeutic use by FXIa chromogenic assay has recently been published in the EDQM online journal Pharmeuropa Bio & Scientific Notes. The article details the methods...
Deadline extended to 30 April: survey on strategy for Ph. Eur. quality standards for monoclonal antibodies
In 2014, the European Pharmacopoeia Commission (EPC) launched a pilot phase on setting public standards for therapeutic monoclonal antibodies (mAbs) (“MAB pilot phase”). This pilot phase was intended to explore the feasibility of establishing individual monographs for multi-source mAbs, as well...
Survey on strategy for Ph. Eur. quality standards for monoclonal antibodies
In 2014, the European Pharmacopoeia Commission (EPC) launched a pilot phase on setting public standards for therapeutic monoclonal antibodies (mAbs) (“MAB pilot phase”). This pilot phase was intended to explore the feasibility of establishing individual monographs for multi-source mAbs, as well...
BSP study outcome published in Pharmeuropa Bio & Scientific Notes – Human tetanus immunoglobulin BRP batch 2
The outcome of the Biological Standardisation Programme study BSP140 to establish the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Human tetanus immunoglobulin batch 2 has been published in the online journal Pharmeuropa Bio & Scientific Notes of the European...
BSP study outcome published online – Heparin Low-Molecular-Mass CRS batches 4 & 5
The outcome of the BSP121 study to establish batches 4 and 5 of the European Pharmacopoeia Heparin Low-Molecular-Mass for Calibration Chemical Reference Substance (CRS) has been published in the online journal Pharmeuropa Bio & Scientific Notes and is referenced in Medline/PubMed® (Pharmeur Bio...
Next-generation sequencing for adventitious virus detection in biologics: EDQM collaborates on article published in Biologicals
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has co-authored a report with a broad range of academics and interested parties, entitled “Report of the third conference on next-generation sequencing for adventitious virus detection in biologics for humans and animals”....
2022 Highlights – EDQM annual report now available
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published its 2022 annual report, providing a comprehensive overview of its activities and achievements, and putting select data on the present state of EDQM/Council of Europe public health initiatives at your...
New Pharmeuropa Bio & Scientific Notes article now online: HCV RNA for NAT BRP replacement batch
Following the successful completion of the Biological Standardisation Programme (BSP) study for the establishment of batch 2 of the Hepatitis C Virus (HCV) RNA for nucleic acid amplification techniques (NAT) Biological Reference Preparation (BRP), the outcome has been published in the online...