KBI Biopharma
Durham, NC · Boulder, CO
No confirmed program data — ClinicalTrials.gov verification pending
· Last scored 2026-09-07
84.4
Signal Score
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
○ Press
○ EMA GMP
✓ MHRA GMP (1)
Quick Facts: KBI Biopharma
- Signal Score
- 84.4/100 (as of 2026-09-07)
- Quality Compliance
- 99.1/100
- Headquarters
- Durham, NC · Boulder, CO
- Website
- https://kbibiopharma.com
- Modalities
- Monoclonal Antibody, Recombinant Protein, AAV (analytical only), Plasmid DNA
- Active Programs
- Data pending
- 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
Scores are being republished.
Scores are being republished under methodology v3.3. The score shown is the last complete v3.2 result, which is also what directory listings and search results show. A pillar breakdown is not shown because the current one is computed under v3.3 and would not explain a v3.2 score. Regulatory evidence below is current.
Quality Compliance
99.1
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 (analytical only), Plasmid DNA
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability
75.0
Profile-based financial assessment
SEC FilingsPrivate company
Capacity
68.0
Capacity status: Limited
StatusLimited
KBI Biopharma FDA Inspection History
2026-04
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-04-01 |
KBI Biopharma, Inc.
Durham, North Carolina
Facility-linked
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 07, 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 Oct 07, 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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