Allergen manufacturing and quality aspects for allergen immunotherapy in Europe and the United States: An analysis from the EAACI AIT Guidelines Project

Author:

Bonertz A.1ORCID,Roberts G.234ORCID,Slater J. E.5,Bridgewater J.5,Rabin R. L.5,Hoefnagel M.6,Timon M.7,Pini C.8,Pfaar O.910ORCID,Sheikh A.11,Ryan D.1213ORCID,Akdis C.14,Goldstein J.15,Poulsen L. K.16,van Ree R.17,Rhyner C.14,Barber D.18,Palomares O.19,Pawankar R.20,Hamerlijnk D.21,Klimek L.10,Agache I.22,Angier E.23,Casale T.24,Fernandez-Rivas M.25,Halken S.26,Jutel M.2728,Lau S.29,Pajno G.30,Sturm G.3132,Varga E. M.33,Gerth van Wijk R.34,Bonini S.35,Muraro A.36,Vieths S.1

Affiliation:

1. Paul-Ehrlich-Institut; Langen Germany

2. University of Southampton; Southampton UK

3. University Hospital Southampton NHS Foundation Trust; Southampton UK

4. David Hide Asthma and Allergy Research Centre; Newport UK

5. US Food and Drug Administration; Silver Spring MD USA

6. CBG-MEB (Medicines Evaluation Board); Utrecht The Netherlands

7. Division of Biological Products; Advanced Therapies and Biotechnology; Agencia Española de Medicamentos y Productos Sanitarios (AEMPS); Madrid Spain

8. Istituto Superiore di Sanità; Rome Italy

9. Department of Otorhinolaryngology, Head and Neck Surgery; Medical Faculty Mannheim; Universitätsmedizin Mannheim; Heidelberg University; Mannheim Germany

10. Center for Rhinology and Allergology; Wiesbaden Germany

11. The University of Edinburgh; Scotland UK

12. Usher Institute of Population Health Sciences and Informatics; University of Edinburgh Medical School; Edinburgh UK

13. Asthma UK Centre for Applied Research; The University of Edinburgh; Edinburgh UK

14. Swiss Institute of Allergy and Asthma Research; University Zurich; Davos Switzerland

15. Division of Allergy, Immunology and Transplantation; National Institute of Allergy and Infectious Diseases; National Institutes of Health; Bethesda MD USA

16. Allergy Clinic; Copenhagen University Hospital at Gentofte; Copenhagen Denmark

17. Departments of Experimental Immunology and of Otorhinolaryngology; Academic Medical Center; University of Amsterdam; Amsterdam The Netherlands

18. Universidad CEU San Pablo; Madrid Spain

19. Department of Biochemistry and Molecular Biology; School of Chemistry; Complutense University of Madrid (UCM); Madrid Spain

20. Nippon Medical School; Tokyo Japan

21. Patient advocacy Group; Dutch Lung Foundation; Amersfoort The Netherlands

22. Faculty of Medicine; Department of Allergy and Clinical Immunology; Transylvania University Brasov; Brasov Romania

23. Sheffield Teaching Hospital; Sheffield UK

24. University of South Florida; Tampa FL USA

25. Allergy Department; Hospital Clinico San Carlos, IdISSC; Madrid Spain

26. Hans Christian Andersen Childrens Hospital; Odense University Hospital; Odense Denmark

27. Wroclaw Medical University; Department of Clinical Immunology; Wroclaw Poland

28. ALL-MED Medical Research Institute; Wroclaw Poland

29. Department for Pediatric Pneumology and Immunology; Charité Universitätsmedizin; Berlin Germany

30. Department of Pediatrics and Allergy Unit; University of Messina; Messina Italy

31. Department of Dermatology and Venerology; Medical University of Graz; Graz Austria

32. Outpatient Allergy Clinic Reumannplatz; Vienna Austria

33. Medical University of Graz; Graz Austria

34. Erasmus MC; Rotterdam The Netherlands

35. University of Campania Luigi Vanvitelli; IFT-CNR; Naples and Rome Italy

36. Padua University Hospital; Padua Italy

Funder

European Academy of Allergy & Clinical Immunology

Publisher

Wiley

Subject

Immunology,Immunology and Allergy

Reference58 articles.

1. The European Parliament and Council Directive 2001/83/EC. The community code relating to medicinal products for human use

2. Standardization of house dust mite extracts in Korea;Jeong;Allergy Asthma Immunol Res,2012

3. Evaluation of extraction buffers using the current approach of detecting multiple allergenic and nonallergenic proteins in food;Westphal;J AOAC Int,2004

4. Comparison of different extraction methods of Alternaria allergens;Paris;J Allergy Clin Immunol,1990

5. International consensus on allergy immunotherapy;Jutel;J Allergy Clin Immunol,2015

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