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OIT-004 / 2.1

Controlled processing and protein recovery

Process development and control; no recipe, temperature or time is supplied as a validated setting.

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

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Procedure

  1. Document the process flow for the exact material and form: milling, wetting, mixing, heating, cooling, filtration and filling where applicable.
  2. Define critical parameters from study of the specific process. Previous experience at another strength does not demonstrate process equivalence.
  3. Measure actual product temperature, time and cooling conditions. Heating is not automatically sterilisation or allergen neutralisation.
  4. For filtration/sieving document material, size, retention and residue composition. Removing solids may alter the delivered protein.
  5. Relate input/output mass and volume to suitable analysis before and after critical stages. Total mass balance does not establish allergen balance.
  6. Approve operating ranges, sampling and criteria before routine use. Do not compensate for protein losses by arbitrarily adding raw material.

Additional detail

Analyte recovery (%) = 100 × output analyte amount / input analyte amount, using the same analytical basis. Assess discarded filters/solids where needed for balance, including dilution and volume changes. Total mass balance does not guarantee allergenic-protein balance.

Recovery testing concerns the defined analyte and stage. Acceptable total-protein recovery does not establish that heating or filtration preserved the same allergenic profile.

Stop criterion

Unknown recovery, uncontrolled heating or unassessed filtration changes: quarantine.

Related forms

F-002, 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