Newsroom Biological standardisation programme
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: Assay discrepancies using human coagulation factor VIII chromogenic kits
The outcome of a study to investigate reported assay discrepancies using human coagulation factor VIII chromogenic kits has been published in the online journal Pharmeuropa Bio & Scientific Notes. The study confirmed a significant discrepancy between the commercial chromogenic kits on the market...
The EDQM participated in a conference on Next Generation Sequencing
On 27-28 September, representatives of the EDQM participated in the 3rd Conference on Next Generation Sequencing for Adventitious Virus Detection in Biologics for Humans and Animals organised by the International Alliance for Biological Standardization (IABS) in Rockville, Maryland, U.S.A. At the...
Ph. Eur. Human immunoglobulin for electrophoresis BRP batch 4 – outcome of establishment study published online
Following the adoption of batch 4 of the European Pharmacopoeia Biological Reference Preparation (Ph. Eur. BRP) for human immunoglobulin for electrophoresis by the Ph. Eur. Commission, the outcome of the establishment study has been published in Pharmeuropa Bio & Scientific Notes, a freely...
BSP study publication: Somatropin/desamidosomatropin resolution mixture CRS 2
An article on the outcome of the Biological Standardisation Programme (BSP) study for the establishment of the European Pharmacopoeia (Ph. Eur.) Somatropin/desamidosomatropin resolution mixture Chemical Reference Substance batch 2 is now available free online. The article has been published in...
Pharmeuropa Bio & Scientific Notes now accessible without registration
Pharmeuropa Bio & Scientific Notes, a free online journal of the European Directorate for the Quality of Medicines & HealthCare (EDQM) indexed in Medline/PubMed®, can be consulted without prior registration as of 13 June 2022. The journal seeks to disseminate knowledge on methods of analysis...
New BSP study publication: Heparin Low-Molecular-Mass for Assay BRP
An article on the outcome of the Biological Standardisation Programme (BSP) study for the establishment of the European Pharmacopoeia (Ph. Eur.) Heparin Low-Molecular-Mass for Assay Biological Reference Preparation batch 11 is now available online. The article has been published in Pharmeuropa...
New Pharmeuropa Bio & Scientific Notes article now online: Human immunoglobulin for ACA BRP
A new scientific article on the outcome of a recently concluded Biological Standardisation Programme (BSP) study has been published in Pharmeuropa Bio & Scientific Notes 2022. Four replacement batches of the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Human...
Proceedings of Workshop on alternatives to animal testing in Quality Control of Veterinary Vaccines now available
The proceedings of the workshop "Novel in-vitro model as alternative to in vivo toxoid vaccines testing: Clostridium septicum vaccine as proof of concept" have been published in FreePub, a free online EDQM journal. The event, held in March 2021, was jointly organised by the European Directorate...
EDQM Laboratory’s ISO 17025:2017 accreditation renewed
The European Directorate for the Quality of Medicines & HealthCare (EDQM) Laboratory successfully obtained the renewal of its accreditation according to the ISO/IEC 17025:2017 standard in October 2021 from the Belgian accreditation organisation BELAC, confirming the validity of the results...
New publication on an EDQM Biological Standardisation Programme study for standardisation of allergen products
Following the successful completion of the BSP090 study on recombinant major allergens, in collaboration with project leaders from the Paul-Ehrlich-Institut, an article on one of the major study outcomes “Validation of a candidate European Pharmacopoeia standard method for quantification of major...
Clostridium septicum vaccine antigen assays: new article available online in Pharmeuropa Bio & Scientific Notes
The outcome of Part 2 of the BSP130 collaborative study run under the common aegis of the European Partnership for Alternative Approaches to Animal Testing (EPAA) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) Biological Standardisation Programme (BSP) has just been...
New Pharmeuropa Bio & Scientific Notes article: Factor VIII BRP
An article on the successful outcome of a recent study of the Biological Standardisation Programme (BSP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) has been published in Pharmeuropa Bio & Scientific Notes, the EDQM’s free online journal. The study for the...
New Pharmeuropa Bio & Scientific Notes article: Pertussis Toxin BRP batch 2
A new article on the successful outcome of the study for the establishment of European Pharmacopoeia Pertussis Toxin Biological Reference Preparation (BRP) batch 2 has been published in Pharmeuropa Bio & Scientific Notes.
Phasing out animal testing for in-process control of veterinary vaccines: Clostridium septicum as a proof of concept
On 9 and 10 March 2021, a workshop aimed at facilitating the implementation of replacement in vitro toxicity and antigenicity assays for Clostridium septicum vaccine antigens was jointly organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM/Council of Europe), the...
Ph. Eur. Commission adopts revised monograph on Erythropoietin concentrated solution (1316)
The approach to the elaboration of European Pharmacopoeia (Ph. Eur.) monographs for biotherapeutics has significantly evolved in recent years. In particular, where monographs on complex biotherapeutics are concerned, the emphasis is now placed on allowing greater flexibility as a means of better...
Pertussis Toxin BRP batch 2 available soon
The Ph. Eur. Commission adopted the replacement batch (batch 2) of the Pertussis Toxin Biological Reference Preparation by correspondence in May 2020. Batch 1 is currently available for regular sales. Batch 2 will be available from the EDQM once the remaining stocks of batch 1 have been...
EDQM website search engine deactivated
The EDQM regrets to inform its users that the search engine on its website has been deactivated and is currently unavailable for technical reasons. We are aware of this recurring issue and are working on a long-term solution. We therefore request that our users refrain from contacting the EDQM...
Ph. Eur. to replace Histamine Sensitisation Test (HIST) for residual pertussis toxin testing
The European Pharmacopoeia (Ph. Eur.) Commission has decided to replace the Histamine Sensitisation Test “HIST” (test in mice) with a standardised CHO cell clustering assay (in vitro cell-based test) for residual pertussis toxin testing in acellular pertussis vaccines, as of next year. The...
EDQM welcomes WHO recommendation to discontinue innocuity test in guidelines on vaccines and biologicals
The EDQM has welcomed the recommendation of the WHO Expert Committee on Biological Standardization (ECBS) to omit the abnormal toxicity test (also called the innocuity test) in all future WHO documents on vaccines and other biological products, and to disregard the inclusion of this test in...