ToxSci Advance Access published online on March 3, 2007
Toxicological Sciences, doi:10.1093/toxsci/kfm020
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The Utility of an International Sera Bank for Use in Evaluating the Potential Human Allergenicity of Novel Proteins
a International Life Sciences Institute Health and Environmental Sciences Institute, One Thomas Circle NW, Ninth Floor, Washington, DC 20005 b Monsanto Co. 800 North Lindbergh Boulevard, St. Louis, MO 63167 c Bayer CropScience, 355 rue Doistoïevski, 06903 Sophia Antipolis Cedex, France d Dupont Company, E400/4402, Route. 141 & Henry Clay Road., Wilmington, DE 19880-0400 e Pediatric Allergy and Immunology, Duke University Medical Center, Durham, NC 27710 f Samsung Medical Center – SungKyunKwan University School of Medicine, 50 Ilwon-dong, Kangnam-Ku, Seoul, Korea, 135-710 g BASF Plant Science, 26 Davis Drive, Research Triangle Park, NC 27709 h Leitende Arztin a.i. Allergiestation und Epikutanlabor, Allergiestation, Dermatologische Klinik, Univversitatsspital Zurich, Gloriastr. 31, CH-8091 Zurich i Paul-Ehrlich-Institut, Division of Allergology, Paul-Ehrlich-Str. 51-59, D-63225 Langen, Germany
* Corresponding author: Tel.: 202-659-0074; fax: 202-659-33617. E-mail: kthomas{at}ilsi.org
Received February 8, 2007; accepted February 12, 2007
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Abstract |
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In the safety assessment of novel foods produced through biotechnology, careful consideration is given to determining the allergenic potential of newly introduced proteins. IgE serum screening is one tool for evaluating whether the protein in question has sequence identity to a known allergen or if the source of the gene encoding the protein is a known allergenic food. A specific serum screen involves testing a gene product with sera from patients with documented clinical allergy to a specific allergen to confirm that the gene product of interest is not the same protein to which the patient produces IgE antibodies. A targeted serum screen involves testing the gene product of interest with sera from patients sensitive to food or aeroallergens from the same broad group. The concept of a global sera bank with accessible, well-characterized sera for use in such assays is an appealing option. This paper summarizes the consensus elements from a workshop to evaluate the potential utility of an international sera bank for evaluating the allergenicity of novel proteins . Areas of agreement following the workshop included: 1) specific sera screens are appropriate for exploring potentially cross-reactive proteins that have been identified through bioinformatics analyses, however, additional validation is needed, particularly for targeted sera screens; 2) practical and ethical considerations may preclude the formation of a global sera bank; and therefore, 3) a regional network of clinicians that could serve as sources of patient sera or be approached to conduct sera studies would be the most practical alternative.
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