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ALG-002 / 3.0

Peanut — suspension-development dossier

Final evidence review of the existing suspension example. Clinical literature and authorised products do not establish this local product’s concentration, uniformity or dating. The publication remains a technical development dossier.

Collection and scientific editing: Stasinos Chr. SikaliasContent edition: 3.0Record editorial review date: 2026-10-14

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Material and strength basis

Record Arachis hypogaea, form/milling, roasting or defatting, lot and allergenic contaminants. Distinguish food mass from total protein and individual-analyte content. A well-characterised material does not automatically establish suspension uniformity.

Redispersibility and syringe

Study particle distribution, settling, compact sediment and recovery after the intended shaking. Check clogging, dead volume, adsorption and actual withdrawal with the exact syringe/adapter. Assess delivery during the last container withdrawals too.

What PALFORZIA evidence covers

FDA labelling covers a specific standardised powder. Strength is expressed as peanut protein, with specifications for Ara h 1, Ara h 2 and Ara h 6. Preparation uses semisolid food for prompt consumption, without mixing into liquid. This does not support storage of a local suspension. The clinical team assesses anaphylaxis, asthma control and a history of eosinophilic gastrointestinal diseases; this is product labelling, not a substitution protocol.

Dating and release

Require protein/analyte retention, uniformity, microbiology and in-use data for the exact matrix. Refrigeration does not replace a study. This dossier assigns no numerical BUD. Release requires technical and clinical agreement with results, not only a completed form.

Analytical-suitability plan

The quantitative method needs specificity, recovery and repeatability assessment in the exact vehicle and lowest proposed measurement range. Document detection/quantification limits, extraction and sample dilution. A negative result from an unsuitable method does not establish allergen absence. Assess uniformity in the actual withdrawn amount after defined shaking, not only in a fully homogenised composite sample.

Final aw and BUD decision

Dry-powder or peanut-butter aw does not transfer to an aqueous suspension. Finished-matrix evidence is required if aw is used to justify dating. Do not automatically select a USP-table BUD: suitable initial strength and dose delivery first need to be established. This dossier’s disposition is development without release for clinical use until actual data are available.

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. PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 1 March 2014Chapters 1–9; Annex 2 (nonsterile liquids, creams, ointments)Professional quality-system framework; not automatic national legal adoption or certification2026-10-14
  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
  6. USP — Compounding Standards and Beyond-Use Dates, 2022 updateNovember 2022, published by USP; public copy hosted by Mississippi Boardpp. 1–2; nonsterile tableRisk-based default categories; not product-specific stability or Greek law2026-10-14
  7. FDA — Water Activity (aw) in FoodsInspection Technical Guide 39, 16 April 1984; website copy accessed 2026-09-12Definition; sorption behaviour; measurement equipmentMetrological principles only. Food regulatory thresholds and old instrument recommendations are not pharmaceutical BUD rules2026-10-14