URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of BrentuximabVedotin_ADCPlatformQualityChecker for Brentuximab Vedotin ADC Platform Quality Checker.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of Antibody-Drug Conjugate (ADC):
• • Protein Concentration: Within specification
• • Aggregates: ≤2.0%
• • Free Drug (MMAE): ≤1.0%
• • Endotoxins: ≤0.5 EU/mg
• • Sterility: Mandatory
• • Purity (SEC-HPLC): ≥95.0%
• ⚠️ CRITICAL: High level of free MMAE causes systemic toxicity.
• BatchNumber,DAR,ProteinConcMgPerMl,AggregatesPercent,FreeDrugPercent,EndotoxinsEUPerMg,SterilityTest,PuritySECPercent,PotencyEC50
• Example (sterility: 0=sterile):
• ⚠️ CRITICAL:
• • DAR 3.5–4.5 — optimal ratio for balance of efficacy and stability
• • Aggregates ≤2.0% — antibody aggregates can cause immune reactions
• • Free MMAE ≤1.0% — free toxin causes severe side effects (neuropathy, myelosuppression)
• • Endotoxins ≤0.5 EU/mg — safety for IV administration
• • Sterility — mandatory for all parenteral forms
• • Purity ≥95.0% — absence of antibody fragments and other impurities
• • Monitoring of free toxin (MMAE) as a critical safety parameter

URS — User Requirements Specification

input.csv contract

BatchNumber,DAR,ProteinConcMgPerMl,AggregatesPercent,FreeDrugPercent,EndotoxinsEUPerMg,SterilityTest,PuritySECPercent,PotencyEC50
BV-ADC-2026-001,4.0,5.0,1.2,0.4,0.2,0,98.5,15.0
BV-ADC-2026-002,3.8,4.8,1.5,0.6,0.3,0,97.0,16.5

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "brentuximab-vedotin-adc-platform-quality-checker",
  "utilityFolder": "BrentuximabVedotin_ADCPlatformQualityChecker",
  "package": "Biopharmaceuticals Extended QC Suite",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-07-02T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "BV-ADC-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "DAR",
      "value": "4.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "ProteinConcMgPerMl",
      "value": "5.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "AggregatesPercent",
      "value": "1.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "FreeDrugPercent",
      "value": "0.4",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "EndotoxinsEUPerMg",
      "value": "0.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "SterilityTest",
      "value": "0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "PuritySECPercent",
      "value": "98.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "PotencyEC50",
      "value": "15.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "BrentuximabVedotin_ADCPlatformQualityChecker.documentation.html"
  }
}

Traceability matrix

IQ/OQ/PQ test scenarios

QA/QC and change control

• Do not rename columns without updating validator, documentation and test set.
• Retain input.csv, output.json, executable version and checksum.
• Before production use, perform IQ/OQ/PQ or equivalent CSV/CSA verification.
• Critical limits shall be verified against the approved specification, registration dossier and local SOPs.
• For combination products, document whether the specialized FDC utility or fallback component checks were used.
• The utility provides structured QC decision support; final release decision remains with QA/QP and approved procedures.