Genezen

Indianapolis, IN · Lexington, MA
AAV Lentiviral
Program data pending ClinicalTrials.gov matching · Last scored 2026-04-02
78.1
Signal Score
✓ FDA Inspections (1) ○ Clinical Trials ○ SEC Filings ○ Press ○ EMA GMP ○ MHRA GMP

Quick Facts: Genezen

Signal Score
78.1/100 (as of 2026-04-02)
Quality Compliance
100.0/100
Headquarters
Indianapolis, IN · Lexington, MA
Modalities
AAV, Lentiviral
Active Programs
No ClinicalTrials.gov matches confirmed
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
Scored By
CDMO Signal — independent CDMO intelligence platform

Signal Score & Pillar Breakdown

Quality Compliance 100.0
FDA Inspections1 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2025-08-27)
Operations —
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs — no verified data
Sponsors— no verified data
ModalitiesAAV, Lentiviral
No clinical trial matches found for this manufacturer
Operational score requires ClinicalTrials.gov data
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability 60.0
Private company
Financial assessment: 60.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Private company
Financial assessment: 60.0/100
Capacity 58.0
1 manufacturing site: Indianapolis, IN
Modalities: AAV, Lentiviral
Capacity assessment: 58.0/100
Sites: Indianapolis, IN
Source: SEC EDGAR, press monitoring, company profiles
1 manufacturing site
StatusAvailable
1 manufacturing site: Indianapolis, IN
Modalities: AAV, Lentiviral
Capacity assessment: 58.0/100
Sites: Indianapolis, IN
1 manufacturing site: Indianapolis, IN
Modalities: AAV, Lentiviral
Capacity assessment: 58.0/100

FDA Inspection History

2025-08
NAI VAI OAI
Date Site Type Observations Classification
2025-08-27 Lexington, Massachusetts Human Cellular, Tissue, and Gene Therapies No No Action Indicated (NAI)
Source: FDA Data Dashboard · Retrieved Apr 05, 2026
Represent this organization? Contact us to verify or update this profile.
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