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Development of certified reference materials for allergenic products and validation of methods for their quantification (CREATE)

Objective

Allergen products used for diagnosis and treatment of allergy are based on natural, heterogeneous allergen extracts. Standardization of these complex biologicals is based on measurement of their overall IgE binding potency by skin tests and immunoassays with pooled allergic sera. Differences in composition are not revealed and the major disease related components, the major allergens, are not individually quantified. Consequently, allergen products on the market are ill defined and not directly comparable. Measurement of major allergens in mass units is the solution to this problem. The proposal aims at the development of CRMs based on recombinant or natural versions of 8 major allergens from 4 of the most important allergen sources in Europe: birch, grass and olive pollen and house dust mite. Recombinant allergens will be compared physico-chemically and immunologically with their natural counterparts. Based on this analysis, candidate CRMs will be selected. In addition, monoclonal antibody based sandwich ELISAs for their measurement will be produced and validated. Together this will improve standardization and comparability of allergen products, resulting in increased safety and efficacy.

Funding Scheme

CSC - Cost-sharing contracts
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Coordinator

CLB - SANQUIN BLOOD SUPPLY FOUNDATION
Address
Plesmanlaan 125
1066 CX Amsterdam
Netherlands

Participants (17)

ALK-ABELLO AS
Denmark
Address
Boge Alle 6-8
2970 Hoersholm
ALLERGOPHARMA JOACHIM GANZER KG
Germany
Address
Hermann Koernerstrasse 52
21465 Reinbek
ASAC PHARMACEUTICAL INTERNATIONAL A.I.E.
Spain
Address
Sagitario 14
03006 Alicante
BERUFSGENOSSENSCHAFTLICHES FORSCHUNGSINSTITUT FUER ARBEITSMEDIZIN
Germany
Address
Buerkle-de-la-camp Platz 1
44789 Bochum
BIOMAY PRODUKTIONS- UND HANDELSGESELLSCHAFT M.B.H.
Austria
Address
Universitaetstrasse 11
4020 Linz
CBF LETI S.A.
Spain
Address
Sol 5
28760 Tres Cantos
HAARLEMS ALLERGENEN LABORATORIUM B.V.
Netherlands
Address
Parklaan 125
2011 KT Haarlem
IMPERIAL COLLEGE OF SCIENCE, TECHNOLOGY AND MEDICINE
United Kingdom
Address
Norfolk Place, Paddington
W2 1PG London
INDOOR BIOTECHNOLOGIES LIMITED
United States
Address
Mr-4 Building - Lane Road
VA 22908 Charlottesville
ISTITUTO SUPERIORE DI SANITA
Italy
Address
Viale Regina Elena 299
00161 Roma
NATIONAL BIOLOGICAL STANDARDS BOARD
United Kingdom
Address
Blanche Lane, South Mimms
EN6 3QG Potters Bar
PAUL-EHRLICH-INSTITUT, FEDERAL AGENCY FOR SERA AND VACCINES
Germany
Address
Paul-ehrlich-strasse 51-59
63225 Langen
RESEARCH CENTER BORSTEL, CENTER FOR MEDICINE AND BIOLOGICAL SCIENCE
Germany
Address
Parkallee 1-40
23845 Borstel
STALLERGENES SA
France
Address
Rue Alexis De Tocqueville 6
Antony
UNIVERSIDAD COMPLUTENSE DE MADRID
Spain
Address
Ciudad Universitaria
28040 Madrid
UNIVERSITY OF SALZBURG
Austria
Address
Hellbrunner Strasse 34
5020 Salzburg
UNIVERSITY OF VIENNA
Austria
Address
Waehringer Guertei 18-20
1090 Wien