KBI Biopharma

Durham, NC · Boulder, CO
AAV Plasmid DNA
Program data pending ClinicalTrials.gov matching · Last scored 2026-04-02
83.5
Signal Score
○ FDA Inspections ○ Clinical Trials ○ SEC Filings ○ Press ○ EMA GMP ✓ MHRA GMP (1)

Quick Facts: KBI Biopharma

Signal Score
83.5/100 (as of 2026-04-02)
Quality Compliance
100.0/100 — No FDA inspection records found for this manufacturer
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

Signal Score & Pillar Breakdown

Quality Compliance 100.0
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Source: FDA Data Dashboard
No FDA inspection records found for this manufacturer · Quality score requires FDA inspection data
FDA InspectionsNo US records on file
MHRA GMP Certificates1 on record
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
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

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 Apr 05, 2026
Represent this organization? Contact us to verify or update this profile.
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