CE_mAb_Aggregates_Fragments

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface, user requirements and functional behaviour of CE_mAb_Aggregates_Fragments. The utility is intended for automated verification of laboratory, pharmacopoeial, analytical or manufacturing QC parameters using input.csv and producing a structured output.json result.

Domain limits and critical parameters

• • Allows separation of intact antibodies, their aggregates (dimers, oligomers), and fragments (light and heavy chains).
• • Aggregates are a critical quality attribute as they can trigger patient immune responses.
• • Fragments result from hydrolysis or proteolysis and reduce therapeutic efficacy.
• • The method requires high resolution and precise peak integration.
• • Aggregates (HMW) must be minimal (<2.0%). Their presence indicates stability or purification issues.
• • Main Peak (Intact) must dominate (>95.0%).
• • Fragments (LMW) are strictly controlled as they lack full activity.
• • Resolution (Rs) ≥1.5 is necessary for accurate quantification.
• • Assessment of mAb purity profile via CE-SDS.
• • Control of high and low molecular weight impurities.
• • Compliance with USP <1053> and Ph. Eur. 2.2.47 requirements.
• • Aggregates (HMW): ≤2.0%
• • Main Peak (Intact): ≥95.0%
• • Fragments (LMW): ≤3.0%
• • Resolution: ≥1.5
• • Aggregates (High Molecular Weight, HMW): ≤2.0%

URS — User Requirements Specification

input.csv contract

BatchNumber,Aggregates%,MainPeak%,Fragments%,Resolution
MAB-CE-2026-001,0.8,97.5,1.7,2.5
MAB-CE-2026-002,1.2,96.0,2.8,2.2
MAB-FAIL-AGG,3.5,94.0,2.5,1.8

FS — Functional Specification

Example output.json

{
  "utilityId": "ce-mab-aggregates-fragments",
  "utilityName": "CE_mAb_Aggregates_Fragments",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "MAB-CE-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Aggregates%",
      "value": "0.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "MainPeak%",
      "value": "97.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Fragments%",
      "value": "1.7",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Resolution",
      "value": "2.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "generatedFor": "QA/QC review and LIMS integration"
}

Traceability matrix

OQ/PQ test scenarios

QA/QC and change control

• Do not rename columns without updating the validator, documentation and test set.
• Retain input.csv, output.json, executable version, documentation and checksum.
• Before production use, perform IQ/OQ/PQ or equivalent CSV/CSA verification.
• Critical limits must be verified against the approved specification, local SOPs and registration dossier.