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OIT-005 / 2.1

Uniformity, redispersibility and dosing device

Demonstrating consistent concentration in the finished product and delivery device.

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

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Procedure

  1. Define quality attributes: measured protein/analyte, uniformity, particles and the amount delivered by the dosing device.
  2. Design sampling at different vessel locations and beginning/middle/end of filling as justified by the study. Do not sample only the easiest location.
  3. Study settling and redispersibility after representative standing periods. Define shaking that a user can realistically perform.
  4. Assess delivered-volume accuracy, clogging, dead volume and adsorption in the chosen syringe/adapter. Do not assume all dosing devices are equivalent.
  5. Use analysis suitable for the final matrix and low concentrations. Record detection/quantification limits and uncertainty where critical.
  6. Compare results with predefined criteria. Check in-use behaviour and performance toward the proposed BUD.

Additional detail

Testing includes the smallest intended withdrawal, repeated withdrawals near container exhaustion and the longest justified interval without shaking. Assess spiked-sample recovery in the actual matrix, not water alone. Agree strength and variability criteria with clinical and analytical teams before testing.

Agree the smallest measurable prescribed dose and relative uncertainty with the clinical team without creating a treatment schedule. Below the reliable device/method range, a justified alternative concentration/device and full-formula reassessment are needed.

Stop criterion

Failed uniformity, irreversible settling or unreliable dose delivery: no release.

Related forms

F-005, F-009

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