PUB-015 / v1.0
Allergen preparations and quality evidence
Clinical immunotherapy evidence and quality of a specific laboratory preparation are separate questions. Collection dossiers maintain that distinction.
From instructions to actual records
Master record F-002 specifies what should happen. Batch record F-003 records what happened: lots, weights, times, equipment, tests, yield, label and signatures. Enter records when work occurs. A correction retains the original information and adds reason, date and identity. Do not pre-sign results or release decisions.
Tests that answer the question
Appearance identifies some failures but does not establish strength, absence of degradants or microbiological suitability. Select method and criterion for the actual dosage form and use. A suspension needs redispersibility and device-delivered-dose assessment; at low strength, uniform mass does not imply uniform API. A critical specification failure requires quarantine and investigation.
Identity and dose
Pistachio and peanut are different species. Nut mass, total protein and allergenic activity are not equivalent. Processing and filtration can change the amount delivered; suitable analytical basis and uniformity are required.
Clinical evidence in its correct scope
EAACI recommendations address specific foods and populations under specialist care. NUT CRACKER concerns cashew and clinical cross-desensitisation; it does not measure pistachio-syrup stability. PALFORZIA instructions concern that specific product, mixed with semisolid food and consumed promptly.
Required technical dossier
Material identity, concentration with declared basis, protein/analyte recovery, uniformity, redispersibility, dosing device, microbiology, packaging and actual dating evidence. EMA industrial-allergen principles inform the quality framework within an explicitly stated scope. They do not create manufacturing permission or a new clinical protocol.
Sources and references
- 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
- 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
- FDA — PALFORZIA prescribing informationUS prescribing information, July 2024 revision, accessed 2026-09-12Sections 1, 2.3, 4, 5 and 16Specific authorised product only; no equivalence with pharmacy-made peanut preparations2026-09-12
- Elizur A et al. Cashew oral immunotherapy for desensitizing cashew-pistachio allergy (NUT CRACKER study)Allergy. 2022;77:1863–1872Primary clinical study abstract; DOI 10.1111/all.15212Cashew OIT cohort and pistachio cross-desensitisation; no pistachio syrup or peanut suspension stability data2026-09-12