HESI Sera Bank Expert Workshop

The committee hosted a workshop April 25-27, 2006, in Seoul, Korea to evaluate the scientific considerations associated with the development of sera banks to support novel protein allergenicity evaluations.  The specific objectives of the workshop included identifying reasons for performing sera studies for allergenicity evaluations, defining acceptance criteria for the inclusion of sera in a bank, describing the appropriate methods for performing sera studies, and defining criteria for the assessment of sera studies.  The workshop was attended by international experts from government, academia, and industry.  The workshop proceedings were published in Toxicological Sciences.

The 1996 ILSI AII/IFBC report on the Allergenicity of Foods Produced by Genetic Modification recommended that proteins produced from genes derived from allergenic sources, and from genes that are found to be similar in sequence to known allergens should be subjected to an immunoglobulin E (IgE) immunoassay, and if appropriate to in vivo clinical testing.  In addition, the January 2001 Food Agriculture Organization / World Health Organization (FAO/WHO )scientific advisory panel on allergenicity assessment recommended performing both specific and targeted serum screens on proteins produced from genes transferred to produce genetically-modified plants.  The development of a commonly available sera bank would be of great benefit facilitating appropriate solid phase immunoassays.

The specific objectives of the workshop include identifying reasons for performing sera studies for allergenicity evaluations, defining acceptance criteria for inclusion in a sera bank, describing appropriate methods for performing sera studies, and defining criteria for assessment of sera studies.  The target audience for the workshop is international experts from government, academia, and industry.  The workshop is a part of the committee’s broader activities that are focused on advancing the scientific understanding of the relevant parameters for characterizing the allergenic potential of novel proteins and biotechnology products.

Workshop Program

Workshop Participant’s List