KBI Biopharma
Durham, NC · Boulder, CO
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-29
82.6
Signal Score
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
○ Press
○ EMA GMP
✓ MHRA GMP (1)
Quick Facts: KBI Biopharma
- Signal Score
- 82.6/100 (as of 2026-04-29)
- Quality Compliance
- 98.1/100
- Headquarters
- Durham, NC · Boulder, CO
- Modalities
- AAV, Plasmid DNA
- 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
About KBI Biopharma
JSR Corporation subsidiary.
Signal Score & Pillar Breakdown
Quality Compliance
98.1
FDA Inspections1 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2026-04-01)
MHRA GMP Certificates1 on record
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesAAV, Plasmid DNA
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
75.0
Strong parent backing: JSR Corporation
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Strong parent backing: JSR Corporation
Capacity
63.0
2 manufacturing sites
Sites: Durham, NC, Boulder, CO
Source: SEC EDGAR, press monitoring, company profiles
2 manufacturing sites
StatusLimited
2 manufacturing sites
Sites: Durham, NC, Boulder, CO
2 manufacturing sites
FDA Inspection History
2026-04
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-04-01 | Durham, North Carolina | Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved May 20, 2026
MHRA GMP Compliance 1 certificates
2017-07
Compliant
Non-Compliant
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK GMP 48619 Insp GMP 48619/17462240-0001[H] | KBI BIOPHARMA BOULDER | 80301 | 2017-07-31 | COMPLIANT |
Source: MHRA GMDP Database · Retrieved May 20, 2026
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