Cincinnati Children's Vector Production Facility

Cincinnati, OH
National Center
AAV Lentiviral
1 confirmed programs · 1 sponsors · Last scored 2026-04-29
75.2
Signal Score
✓ FDA Inspections (1) ✓ Clinical Trials (1) ○ SEC Filings ○ Press ○ EMA GMP ○ MHRA GMP

Quick Facts: Cincinnati Children's Vector Production Facility

Signal Score
75.2/100 (as of 2026-04-29)
Quality Compliance
100.0/100
Headquarters
Cincinnati, OH
Modalities
AAV, Lentiviral
Active Programs
1 confirmed from ClinicalTrials.gov across 1 sponsors
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
Scored By
CDMO Signal — independent CDMO intelligence platform

About Cincinnati Children's Vector Production Facility

CDMO.

Signal Score & Pillar Breakdown

Quality Compliance 100.0
FDA Inspections1 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2025-02-05)
Operations 60.0
1 active programs across 1 sponsors
Modalities: AAV, Lentiviral
1 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov
1 active programs across 1 sponsors · Modalities: AAV, Lentiviral · 1 programs in advanced phases (Phase 2/3)
Programs 1
Sponsors1
ModalitiesAAV, Lentiviral
1 active programs across 1 sponsors
Modalities: AAV, Lentiviral
1 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov facility matching
NCT00537394 Optimizing Treatment for Treatment-Experienced, HIV-Infected People PHASE3 Completed
Source: ClinicalTrials.gov · Retrieved May 20, 2026
Financial Stability 68.0
Parent company: Cincinnati Children's Hospital
Financial assessment: 68.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Parent company: Cincinnati Children's Hospital
Financial assessment: 68.0/100
Capacity 58.0
1 manufacturing site: Cincinnati, OH
Modalities: AAV, Lentiviral
Capacity assessment: 58.0/100
Sites: Cincinnati, OH
Source: SEC EDGAR, press monitoring, company profiles
1 manufacturing site
1 manufacturing site: Cincinnati, OH
Modalities: AAV, Lentiviral
Capacity assessment: 58.0/100

FDA Inspection History

2025-02
NAI VAI OAI
Date Site Type Observations Classification
2025-02-05 Cincinnati, Ohio Human Cellular, Tissue, and Gene Therapies No No Action Indicated (NAI)
Source: FDA Data Dashboard · Retrieved May 20, 2026

FDA 483 Findings 1 observations · 2025-08-15 → 2025-08-15 ?

By subsystem

  • Documentation & Records 1 (100.0%)

By severity

  • 2 — Minor: 1
  • Repeat observations: 0

Most severe findings

  • Minor (2) Documentation & Records 2025-08-15 21 CFR 820.50
    Purchasing controls, Lack of or inadequate procedures

    "Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established."

About this data →

Clinical Activity 1 studies

NCT00537394 Optimizing Treatment for Treatment-Experienced, HIV-Infected People PHASE3 Completed
Source: ClinicalTrials.gov · Retrieved May 20, 2026
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