ALG-005 / v1.0
Egg allergy and preparation evidence
A new egg source profile separating material type, clinical application and analytical evidence.
Development dossier · No validated formula, clinical dosing schedule or established finished-preparation BUD.
Clinical recommendation
EAACI suggests oral immunotherapy for selected children/adolescents with egg allergy, generally after four years of age, in specialist care. It does not establish a universal regimen or preparation executable without an individual order.
Identity and heat processing
Specify egg white, whole egg or an identified protein material, processing and lot. Baked, pasteurised and powdered products are not assumed equivalent. Heating or acceptable appearance does not establish zero allergenic activity.
Finished-matrix evidence
Actual dose delivery needs a suitable method, uniformity and compatible device. A study of another form or food does not establish preservation of the local product. Any proposed development follows OIT-001 through OIT-008 and an agreed stability plan. No recipe or numerical BUD is provided.
Sources and references
- Santos AF et al. EAACI guidelines on the management of IgE-mediated food allergyAllergy. 2025;80:14–36; online 2024Abstract and published guideline recommendations; DOI 10.1111/all.16345Specialist clinical recommendations; not stability evidence for local syrups or suspensions2026-09-12
- EMA — Guideline on Allergen Products: Production and Quality IssuesEMEA/CHMP/BWP/304831/2007, 2008Sections 2, 4.1.1, 4.2.4, 4.3, 4.4.3–4.4.5; pp. 4–13Industrial biological-allergen quality guidance; principles adapted explicitly, not a compounding authorisation or a food-OIT recipe2026-09-12