Article open access publication

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

Allergy, Wiley, ISSN 1398-9995

Volume 73, 4, 2018

DOI:10.1111/all.13357, Dimensions: pub.1092752698, PMID: 29150848,



  1. (1) Paul Ehrlich Institut, grid.425396.f
  2. (2) David Hide Asthma and Allergy Research Centre, Newport, UK
  3. (3) University Hospital Southampton NHS Foundation Trust, grid.430506.4
  4. (4) University of Southampton, grid.5491.9
  5. (5) United States Food and Drug Administration, grid.417587.8
  6. (6) Medicines Evaluation Board, grid.491235.8
  7. (7) Agencia Española de Medicamentos y Productos Sanitarios, grid.443875.9
  8. (8) Istituto Superiore di Sanità, grid.416651.1
  9. (9) Department of Otorhinolaryngology, Head and Neck Surgery, Medical Faculty Mannheim, Universitätsmedizin Mannheim, Heidelberg University, Mannheim, Germany
  10. (10) Center for Rhinology and Allergology, Wiesbaden, Germany
  11. (11) University of Edinburgh, grid.4305.2
  12. (12) University of Zurich, grid.7400.3
  13. (13) National Institute of Allergy and Infectious Diseases, grid.419681.3
  14. (14) Gentofte Hospital, grid.411646.0, Capital Region
  15. (15) Departments of Experimental Immunology and of Otorhinolaryngology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
  16. (16) CEU San Pablo University, grid.8461.b
  17. (17) Complutense University of Madrid, grid.4795.f
  18. (18) Nippon Medical School, grid.410821.e
  19. (19) Lung Foundation Netherlands, grid.483832.6
  20. (20) Transylvania University of Brașov, grid.5120.6
  21. (21) Sheffield Teaching Hospitals NHS Foundation Trust, grid.31410.37
  22. (22) University of South Florida, grid.170693.a
  23. (23) Hospital Clínico San Carlos, grid.411068.a
  24. (24) Odense University Hospital, grid.7143.1, Southern Denmark Region
  25. (25) ALL‐MED Medical Research Institute, Wroclaw, Poland
  26. (26) Wrocław Medical University, grid.4495.c
  27. (27) Charité, grid.6363.0
  28. (28) University of Messina, grid.10438.3e
  29. (29) Outpatient Allergy Clinic Reumannplatz, Vienna, Austria
  30. (30) Medical University of Graz, grid.11598.34
  31. (31) Erasmus University Medical Center, grid.5645.2
  32. (32) University of Campania "Luigi Vanvitelli", grid.9841.4
  33. (33) Azienda Ospedaliera di Padova, grid.411474.3


Adequate quality is essential for any medicinal product to be eligible for marketing. Quality includes verification of the identity, content and purity of a medicinal product in combination with a specified production process and its control. Allergen products derived from natural sources require particular considerations to ensure adequate quality. Here, we describe key aspects of the documentation on manufacturing and quality aspects for allergen immunotherapy products in the European Union and the United States. In some key parts, requirements in these areas are harmonized while other fields are regulated separately between both regions. Essential differences are found in the use of Reference Preparations, or the requirement to apply standardized assays for potency determination. As the types of products available are different in specific regions, regulatory guidance for such products may also be available in one specific region only, such as for allergoids in the European Union. Region-specific issues and priorities are a result of this. As allergen products derived from natural sources are inherently variable in their qualitative and quantitative composition, these products present special challenges to balance the variability and ensuring batch-to-batch consistency. Advancements in scientific knowledge on specific allergens and their role in allergic disease will consequentially find representation in future regulatory guidelines.


Funders and Grants

Research Categories

Main Subject Area

Fields of Research

Links & Metrics

NORA University Profiles

University of Copenhagen

Dimensions Citation Indicators

Times Cited: 37

Field Citation Ratio (FCR): 12.36

Relative Citation ratio (RCR): 5.37

Open Access Info