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The CREATE Project: development of certified reference materials for allergenic products and validation of methods for their quantification

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Allergen extracts have been used for diagnosis and treatment of allergy for around 100 years. During the second half of 20th century, the notion increasingly gained foothold that accurate standardization of such extracts is of great importance for improvement of their quality. As a consequence, manufacturers have implemented extensive protocols for standardization and quality control. These protocols have overall IgE-binding potencies as their focus. Unfortunately, each company is using their own in-house reference materials and their own unique units to express potencies. This does not facilitate comparison of different products. During the last decades, most major allergens of relevant allergen sources have been identified and it has been established that effective immunotherapy requires certain minimum quantities of these allergens to be present in the administered maintenance dose. Therefore, the idea developed to introduce major allergens measurements into standardization protocols. Such protocols based on mass units of major allergen, quantify the active ingredients of the treatment and will at the same time allow comparison of competitor products. In 2001, an EU funded project, the CREATE project, was started to support introduction of major allergen based standardization. The aim of the project was to evaluate the use of recombinant allergens as reference materials and of ELISA assays for major allergen measurements. This paper gives an overview of the achievements of the CREATE project.
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Keywords: European Directorate for the Quality of Medicines; International Union of Immunological Societies; World Health Organization; allergen standardization; enzyme-linked immunosorbent assay; international standards; major allergens; mass units; recombinant allergens; reference reagents

Document Type: Research Article

Affiliations: 1: Academic Medical Center, Amsterdam, the Netherlands 2: Sanquin, Amsterdam, The Netherlands 3: Stallergènes SA, Antony, France 4: ALK-Abello, Madrid, Spain 5: University Institute Dexeus, Barcelona, Spain 6: University of Manchester, Manchester, UK 7: NIBSC, Potters Bar, UK 8: HAL Allergy BV, Haarlem, the Netherlands 9: Istituto Superiore di Sanita, Rome, Italy 10: Research Center Borstel, Borstel, Germany 11: CBF Leti SA, Madrid, Spain 12: Hospital Clinico San Carlos, Madrid, Spain 13: Allergopharma, Reinbek, Germany 14: Medical University Vienna, Vienna, Austria 15: Paul-Ehrlich Institute, Langen, Germany 16: University of Salzburg, Salzburg, Austria 17: Ramon y Cajal Hospital, Madrid, Spain 18: University Medical Center Utrecht, Utrecht, the Netherlands 19: European Allergen Manufacturers Group, Haarlem, the Netherlands 20: ASAC Pharmaceutical International SA, Alicante, Spain 21: CACeS, IDI-IRCCS, Rome, Italy 22: Biomay AG, Vienna, Austria 23: University Hospital Strasbourg, Strasbourg, France 24: Complejo Hospitalario de Jaen, Jaen, Spain 25: Sahlgrenska University Hospital, Gothenborg, Sweden 26: BGFA, Ruhr-University Bochum, Bochum, Germany 27: Indoor Biotechnologies, Charlottesville, VA, USA

Publication date: March 1, 2008

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