KBI Biopharma
Durham, NC · Boulder, CO
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-29
83.9
Signal Score
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
○ Press
○ EMA GMP
✓ MHRA GMP (1)
Quick Facts: KBI Biopharma
- Signal Score
- 83.9/100 (as of 2026-04-29)
- Quality Compliance
- 98.1/100
- Headquarters
- Durham, NC · Boulder, CO
- Website
- https://kbibiopharma.com
- Modalities
- Monoclonal Antibody, Recombinant Protein, 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
ModalitiesMonoclonal Antibody, Recombinant Protein, AAV, 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
68.0
2 manufacturing sites
Broad modality coverage (4 modalities)
Sites: Durham, NC, Boulder, CO
Source: SEC EDGAR, press monitoring, company profiles
2 manufacturing sites
StatusLimited
2 manufacturing sites
Broad modality coverage (4 modalities)
Sites: Durham, NC, Boulder, CO
2 manufacturing sites
Broad modality coverage (4 modalities)
KBI Biopharma 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 Jul 04, 2026
KBI Biopharma 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 Jul 04, 2026
Frequently Asked Questions About KBI Biopharma
How many FDA inspections does KBI Biopharma have on record?
CDMO Signal tracks 1 FDA inspection for KBI Biopharma, sourced from the FDA inspection database. See the full inspection history above.
Has KBI Biopharma received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for KBI Biopharma.
Does KBI Biopharma hold EMA or MHRA GMP certificates?
CDMO Signal tracks 1 MHRA GMP certificate for KBI Biopharma.
What is KBI Biopharma's CDMO Signal Score?
KBI Biopharma has a Signal Score of 84/100, based on quality, operations, financial stability, and capacity data.
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