FUJIFILM Diosynth Biotechnologies / FUJIFILM Cellular Dynamics (FCDI)

Madison, WI (FCDI) / Research Triangle Park, NC (FDB)
iPSC iPSC-derived cell therapies AAV mRNA/LNP Biologics
Program data pending ClinicalTrials.gov matching
60.0
Signal Score
○ FDA Inspections ○ Clinical Trials ○ SEC Filings ○ Press ✓ EMA GMP (10) ✓ MHRA GMP (6)

Quick Facts: FUJIFILM Diosynth Biotechnologies / FUJIFILM Cellular Dynamics (FCDI)

Signal Score
60.0/100
Quality Compliance
Assessment pending
Headquarters
Madison, WI (FCDI) / Research Triangle Park, NC (FDB)
Modalities
iPSC, iPSC-derived cell therapies, AAV, mRNA/LNP, Biologics
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 —
No FDA inspection records found. This CDMO may operate under a different legal name or may not have US FDA-inspected facilities.
FDA InspectionsNo US records on file
EMA GMP Certificates10 on record
MHRA GMP Certificates6 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
ModalitiesiPSC, iPSC-derived cell therapies, AAV, mRNA/LNP, Biologics
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 60.0
Broad modality coverage (5 modalities)
Source: SEC EDGAR, press monitoring, company profiles
Profile-based capacity assessment
Broad modality coverage (5 modalities)

EMA GMP Compliance 10 certificates

2025-06
2025-06
2025-02
2025-02
2025-02
2025-01
2025-01
2025-01
2024-06
2024-06
Compliant Non-Compliant
Certificate Site Country Inspection Date Status
DK API-H 10001266 FUJIFILM Diosynth Biotechnologies Denmark ApS Denmark 2025-06-12 COMPLIANT
DK H 10001269 FUJIFILM Diosynth Biotechnologies Denmark ApS Denmark 2025-06-12 COMPLIANT
DK API-H 10001234 FUJIFILM Diosynth Biotechnologies Denmark ApS Denmark 2025-02-04 COMPLIANT
DK H 10001235 FUJIFILM Diosynth Biotechnologies Denmark ApS Denmark 2025-02-04 COMPLIANT
DK IMP 10001236 FUJIFILM Diosynth Biotechnologies Denmark ApS Denmark 2025-02-04 COMPLIANT
DK H 10001233 FUJIFILM Diosynth Biotechnologies Denmark ApS Denmark 2025-01-21 COMPLIANT
DK API-H 10001232 FUJIFILM Diosynth Biotechnologies Denmark ApS Denmark 2025-01-21 COMPLIANT
DK IMP 10001237 FUJIFILM Diosynth Biotechnologies Denmark ApS Denmark 2025-01-21 COMPLIANT
DK IMP 10000995 FUJIFILM Diosynth Biotechnologies Denmark ApS Denmark 2024-06-19 COMPLIANT
DK H 10000994 FUJIFILM Diosynth Biotechnologies Denmark ApS Denmark 2024-06-19 COMPLIANT
Source: EMA EudraGMDP · Retrieved Apr 05, 2026

MHRA GMP Compliance 6 certificates

2025-03
2025-03
2025-03
2025-03
2025-03
2025-03
Compliant Non-Compliant
Certificate Site City / Postcode Inspection Date Status
UK MIA 18480 Insp GMP 18480/37423709-0003[H] FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED REDCAR TS10 4RF 2025-03-24 COMPLIANT
UK MIA(IMP) 18480 Insp IMP 18480/37423707-0002[I] FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED DARLINGTON DL1 1HG 2025-03-24 COMPLIANT
UK MIA(IMP) 18480 Insp IMP 18480/37423709-0004[I] FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED REDCAR TS10 4RF 2025-03-24 COMPLIANT
UK MIA(IMP) 18480 Insp IMP 18480/37423705-0002[I] FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED DARLINGTON DL1 1GL 2025-03-24 COMPLIANT
UK MIA(IMP) 18480 Insp GMP/IMP 18480/10934-0018[I] FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED BILLINGHAM TS23 1LH 2025-03-18 COMPLIANT
UK MIA 18480 Insp GMP/IMP 18480/10934-0018[H] FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED BILLINGHAM TS23 1LH 2025-03-18 COMPLIANT
Source: MHRA GMDP Database · Retrieved Apr 05, 2026
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iPSC CDMOs → iPSC-derived cell therapies CDMOs → AAV CDMOs → mRNA/LNP CDMOs → Biologics CDMOs →

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