Development of Certified Reference Materials for Allergenic Products
Allergy 2008: 63: 310–326 Ó 2008 The Authors Journal compilation Ó 2008 Blackwell Munksgaard DOI: 10.1111/j.1398-9995.2007.01612.x EU Forum The CREATE Project: development of certified reference materials for allergenic products and validation of methods for their quantification Allergen extracts have been used for diagnosis and treatment of allergy for R. van Ree1, M. D. Chapman2*, F. around 100 years. During the second half of 20th century, the notion increas- Ferreira3*, S. Vieths4*, D. Bryan5*, ingly gained foothold that accurate standardization of such extracts is of great O. Cromwell6*, M. Villalba7*, importance for improvement of their quality. As a consequence, manufacturers S. R. Durham8*, W. M. Becker9*, have implemented extensive protocols for standardization and quality control. M. Aalbers10,C.AndrØ11, D. Barber12, These protocols have overall IgE-binding potencies as their focus. Unfor- A. Cistero Bahima13, A. Custovic14, tunately, each company is using their own in-house reference materials and their A. Didierlaurent11, C. Dolman5, own unique units to express potencies. This does not facilitate comparison of J. W. Dorpema15, G. Di Felice16, different products. During the last decades, most major allergens of relevant F. Eberhardt9, E. Fernandez Caldas17, allergen sources have been identified and it has been established that effective M. Fernandez Rivas18, H. Fiebig6,M. immunotherapy requires certain minimum quantities of these allergens to be Focke19, K. Fçtisch4, G. Gadermaier3, present in the administered maintenance dose. Therefore, the idea developed to R. G. Das5, E. Gonzalez Mancebo20, introduce major allergens measurements into standardization protocols. Such M. Himly3, T. Kinaciyan19, protocols based on mass units of major allergen, quantify the active ingredients 21 22 9 of the treatment and will at the same time allow comparison of competitor A.
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