FOR PHARMACISTS · SCIENTIFIC COLLECTION 10.0310 monographs · 36 SOPs · 22 forms
Sikaliascompounding.grSikalias Greek Formulary
Home / Quality system / Allergen identity and protein basis · OIT-002

OIT-002 / 2.1

Allergen identity and protein basis

Distinct food-allergen raw materials in separate dossiers: pistachio, peanut, cashew and, where a specific project is approved, milk/egg proteins.

Collection and scientific editing: Stasinos Chr. SikaliasContent edition: 2.1Record editorial review date: 2026-10-14

Download bilingual PDFJSON

Procedure

  1. Qualify the specific source and material: species, nut fraction, processing, milling, defatting and additives. A trade name does not establish equivalence.
  2. Record lot, dates, conditions and possible other allergens. A roasting or supplier change is a critical change.
  3. Define with the analytical partner what the test measures: total protein, a specific allergen or another attribute. These quantities are not interchangeable.
  4. Assess method suitability for the matrix and processing. A nutrition panel or generic conversion factor does not establish this lot’s concentration.
  5. Set hygiene/microbiological and relevant contaminant specifications based on risk. Food-grade quality alone does not establish suitability for the intended therapeutic use.
  6. Release raw material only with reviewed evidence and complete linkage to finished batches. Retain a reference sample where the approved plan requires it.

Additional detail

Declare the measurement basis as food mass, mg total protein or an identified analyte, with reference standard and matrix. For extract products assess the relevant protein profile and major allergens. Cross-species transfer needs specific scientific comparability; taxonomy or cross-sensitisation alone is insufficient.

Total protein, major-allergen profile and biological/immunological activity answer different questions. Justify the analytical strategy and any alternative tests for the exact product; a generic protein result does not establish full potency equivalence.

Stop criterion

Unconfirmed species, unknown processing or insufficient critical protein data: quarantine.

Related forms

F-008

Sources and references

  1. EMA — Guideline on Allergen Products: Production and Quality IssuesEMEA/CHMP/BWP/304831/2007; adopted 20 November 2008; effective 20 May 2009; remains current effective quality version on EMASections 2, 4.1.1, 4.2.4.4, 4.4.3–4.4.5; document pp. 4–13Industrial biological-allergen quality guidance; principles adapted explicitly, not a compounding authorisation or a food-OIT recipe2026-10-14
  2. Santos AF et al. EAACI guidelines on the management of IgE-mediated food allergyAllergy. 2025;80:14–36; online 2024Recommendations 8, 9, 12 and 13; desensitisation versus remission/continued treatmentSpecialist clinical recommendations; not stability evidence for local syrups or suspensions2026-10-14
  3. FDA — PALFORZIA prescribing informationUS prescribing information, Revised 07/2024; rechecked 2026-10-14Sections 2.3, 4, 5, 11 and 16; current FDA-linked labelSpecific authorised product only; no equivalence with pharmacy-made peanut preparations2026-10-14
  4. NAPRA — Guidance Document for Pharmacy Compounding of Non-sterile PreparationsMarch 2018, clarification January 2022Sections 5, 6 and 7; master/batch records, delivery, qualityQuality-system implementation; historical BUD table not substituted for 2022 USP revision2026-10-14
  5. EMA — Guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populationsEMA/161669/2025; adopted 10 June 2025; effective 1 January 2026Sections 2, 4 and 4.1 (Type I allergy quality aspects); pp. 4–6; section 8.4 for food-allergy endpointsIndustrial allergen development and quality guidance; complements 2008 guideline. Section 4.2 Type IV patch-test exceptions are not transferred to food OIT.2026-10-14