Bibliography

The highly qualified EDQM staff regularly contributes to scientific articles published in a variety of journals. The list below presents the articles published in 2024.

External publications

Pharmeuropa Bio & Scientific Notes

Pharmeuropa Bio & Scientific Notes seeks to disseminate knowledge on methods of analysis for pharmaceutical quality control, with a particular emphasis on the results obtained for pharmaceutical products. The journal publishes scientific articles related to biological standardisation with a primary focus on the EDQM Biological Standardisation Programme and the work of the European Pharmacopoeia (Ph. Eur.). It also includes reports on the establishment of key Ph. Eur. reference standards (BRP/CRS/BRR) for biologicals.

All articles published in Pharmeuropa Bio & Scientific Notes in 2024 can be found at: https://pbiosn.edqm.eu/app/pbiosn/search?chapter=201055&title=2024.

  1. Stickings P., Tierney R., Hockley J. et al. (2024), “Collaborative study for the establishment of Ph. Eur. Biological Reference Preparation for Human tetanus immunoglobulin batch 2”, Pharmeur Bio Sci Notes, 2024:1-11.
  2. Bratos M., Kolaj-Robin O., Antoni M. et al. (2024), “Ph. Eur. testing for histamine and depressor substances using guinea-pigs and cats: the end of an era – Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur.”, Pharmeur Bio Sci Notes, 2024:12-26.
  3. Behr-Gross M-E., Le Tallec D., Sinitskaya N. et al. (2024), “Determination of procoagulant activity in human normal immunoglobulin preparations for therapeutic use by FXIa chromogenic assay: Evaluation of test kit sensitivity, reference standard performance and product formulation effects on the FXIa assay”, Pharmeur Bio Sci Notes, 2024:27-75.
  4. Thorpe SJ., Virata ML., Fox B. et al. (2024), “International collaborative study to assess new stocks of candidate reference preparations to control the level of anti-D in IVIG”, Pharmeur Bio Sci Notes, 2024:76-89.
  5. Jouette S. and Regourd E. (2024), “Collaborative study for the establishment of Human immunoglobulin (molecular size) BRP replacement batches 4, 5 and 6”, Pharmeur Bio Sci Notes, 2024: 90-105.
  6. Fox B., Regourd E., Rigsby P. et al. (2024), “Joint WHO/EDQM Collaborative study for the establishment of WHO 3rd International Standard and Ph. Eur. Biological Reference Preparation for Prekallikrein activator in albumin batch 7”, Pharmeur Bio Sci Notes, 2024: 106-126.
  7. Behrensdorf-Nicol H., Krämer B., Le Tallec D. et al. (2024), “Collaborative study for the characterisation of the BINACLE Assay for in vitro detection of tetanus toxicity in toxoids – Part 1”, Pharmeur Bio Sci Notes, 2024: 127-161.
  8. Behrensdorf-Nicol H., Le Tallec D., Sinitskaya N. et al. (2024), “Collaborative study for the characterisation of the BINACLE Assay for in vitro detection of tetanus toxicity in toxoids – Part 2”, Pharmeur Bio Sci Notes, 2024: 162-192.
  9. Kefeder C., Eichmeir S., Le Tallec D. et al. (2024), “Collaborative Study for the Calibration of the Ph.Eur. Prekallikrein Activator in Albumin Biological Reference Preparation batches 8, 9 and 10”, Pharmeur Bio Sci Notes, 2024: 193-220.
  10. Costanzo A., Regourd E., Ridoux V. (2024), “Validation of an ELISA method for determination of physical particle titre of AAV2-based vector preparations”, Pharmeur Bio Sci Notes, 2024: 221-233.
  11. Wadhwa M., Rigsby P., Behr-Gross M-E. (2024), “Collaborative study for the establishment of Golimumab Biological Reference Preparation Batch 1”, Pharmeur Bio Sci Notes, 2024: 234-239
  12. Morgeaux S., Manniam I., Le Tallec D. et al. (2024), “Establishment of hepatitis A virus coating reagent batch 2 for in vitro potency assay of hepatitis A vaccines by ELISA”, Pharmeur Bio Sci Notes, 2024: 240-250.
  13. Cowper B., Le Tallec D., Costanzo A. (2024), “Establishment of Erythropoietin for physicochemical tests CRS batch 2”, Pharmeur Bio Sci Notes, 2024: 251-274.