QAS Newsletter Contribution

September 16, 2020Quality Assessment and Standardization Committee (QAS)

Allergen Standardization Sub-Committee

Chair: Stefan Vieths, PhD, Langen, Germany
Vice Chair: Fatima Ferreira, PhD, Salzburg, Austria

Figure 1: From CREATE to BSP090 – Achievements of two consecutive projects

Allergen products used for therapy for allergic diseases are typically produced from native extracts of the allergenic source, for example pollen. Allergens are (glyco-)proteins present in these source materials in varying amounts. Therefore, standardization of active substance content is challenging and comparison of different products is impossible as long as international allergen standards and standard test methods are missing. The Allergen Standardization Sub-Committee was founded in 1971 under the auspices of the WHO and IUIS with the goal to fill this gap. Major initiatives in the 1980s concentrated on whole allergen extract standards1,2, while recent activities focused on standards prepared from purified single allergen molecules. The first step was the project CREATE3,4, analysing eight allergens and corresponding Enzyme Linked Immunosorbent Assays (ELISAs) for their suitability. The subsequent project BSP0905–7 focused on the two most promising candidates identified in CREATE: The major allergens of birch pollen (Bet v 1) and Timothy grass pollen (Phl p 5). As a result of BSP090, two recombinant allergen standards have been adopted by the European Pharmacopoeia Commission8,9 and the respective ELISAs for Bet v 1 and Phl p 5 quantification have undergone extensive validation in collaborative studies. Both ELISAs have been made commercially available and are to be introduced as standard ELISAs in the European Pharmacopoeia10,11.

References

1.   Campbell, PJ. International biological standards and reference preparations. II. Procedures used for the production of biological standards and reference preparations. Journal of biological standardization 1974;2:259–67.

2.   Platts-Mills, TA, Rawle, F, Chapman, MD. Problems in allergen standardization. Clin Rev Allergy 1985;3:271–90.

3.   van Ree, R, Chapman, MD, Ferreira, F, Vieths, S, Bryan, D, Cromwell, O, et al. The CREATE project: development of certified reference materials for allergenic products and validation of methods for their quantification. Allergy 2008;63:310–26.

4.   Chapman, MD, Ferreira, F, Villalba, M, Cromwell, O, Bryan, D, Becker, WM, et al. The European Union CREATE project: a model for international standardization of allergy diagnostics and vaccines. J Allergy Clin Immunol 2008;122:882–89.

5.   Vieths, S, Barber, D, Chapman, M, Costanzo, A, Daas, A, Fiebig, H, et al. Establishment of recombinant major allergens Bet v 1 and Phl p 5a as Ph. Eur. reference standards and validation of ELISA methods for their measurement. Results from feasibility studies. Pharmeuropa bio & scientific notes 2012;2012:118–34.

6.   Kaul, S, Dehus, O, Zimmer, J, Vieths, S. Validation of major allergen references and ELISAs–current state of the BSP090 project. Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt für Sera und Impfstoffe) zu Frankfurt a.M 2013;97:45–53.

7.   Neske, F, Schorner, C, Buchheit, KH, Costanzo, A, Hanschmann, K-M, Himly, M, et al. BSP090–the follow-up to CREATE. Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt für Sera und Impfstoffe) zu Frankfurt a.M 2009;96:12–19.

8.   Himly, M, Nony, E, Chabre, H, van Overtvelt, L, Neubauer, A, van Ree, R, et al. Standardization of allergen products: 1. Detailed characterization of GMP-produced recombinant Bet v 1.0101 as biological reference preparation. Allergy 2009;64:1038–45.

9.   Himly, M, Nandy, A, Kahlert, H, Thilker, M, Steiner, M, Briza, P, et al. Standardization of allergen products. 2. Detailed characterization of GMP-produced recombinant Phl p 5.0109 as European Pharmacopoeia reference standard. Allergy 2015:n/a-n/a.

10. Kaul, S, Zimmer, J, Dehus, O, Constanzo, A, Daas, A, Buchheit, K-H, et al. Validation of ELISA methods for quantification of the major birch allergen Bet v 1 (BSP090). Pharmeuropa bio & scientific notes 2017;2017:69–87.

11. Kaul, S, Zimmer, J, Dehus, O, Costanzo, A, Daas, A, Buchheit, KH, et al. Standardization of allergen products. 3. validation of candidate european pharmacopoeia standard methods for quantification of major birch allergen bet v 1. Allergy 2016:n/a-n/a.

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