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The Code of Federal Regulations 21<jats:styled-content style=\"fixed-case\">CFR<\/jats:styled-content>680.3(e) states that when measured, the potency of an allergenic extract is assessed according to its allergenic activity. As of 2016, 19 allergenic extracts are standardized for potency in the United States. While these standardized extracts constitute a minority of those available, they treat the most prevalent allergies (e.g. grass and ragweed pollens, dust mites, and cat) and those that induce life\u2010threatening anaphylaxis (e.g. Hymenoptera venom). Standardization for potency enhances safety and efficacy of immunotherapy by minimizing the risks of variations in allergen dosing when switching from one lot of manufactured extract to another, and by providing an objective measure of stability of each lot of allergenic extract over time. Allergenic extracts that have multiple immunodominant allergenic proteins are standardized with little or no information about compositional differences among extracts. Here, we propose application of mass spectrometry towards measurement of compositional differences among extracts that may affect the efficacy and safety of allergen immunotherapy. In addition, we discuss of house dust mite allergen extracts as a prototypical complex extract that may be standardized by mass spectrometry.<\/jats:p>","DOI":"10.1111\/cea.12931","type":"journal-article","created":{"date-parts":[[2017,4,3]],"date-time":"2017-04-03T20:29:50Z","timestamp":1491251390000},"page":"604-617","source":"Crossref","is-referenced-by-count":20,"title":["Mass spectrometry to complement standardization of house dust mite and other complex allergenic extracts"],"prefix":"10.1111","volume":"47","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9027-4774","authenticated-orcid":false,"given":"J.","family":"Spiric","sequence":"first","affiliation":[{"name":"Laboratory of Immunobiochemistry Division of Bacterial, Parasitic, and Allergenic Products Office of Vaccine Research and Review CBER\/FDA Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Reuter","sequence":"additional","affiliation":[{"name":"Division of Allergology Paul\u2010Ehrlich\u2010Institut Langen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R. 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