Bayer (Cell Therapy Mfg)
Berkeley, CA
124 confirmed programs
· 51 sponsors
· Last scored 2026-04-02
83.8
Signal Score
✓ FDA Inspections (4)
✓ Clinical Trials (124)
○ SEC Filings
○ Press
✓ EMA GMP (11)
✓ MHRA GMP (1)
Quick Facts: Bayer (Cell Therapy Mfg)
- Signal Score
- 83.8/100 (as of 2026-04-02)
- Quality Compliance
- 100.0/100
- Headquarters
- Berkeley, CA
- Modalities
- Cell Therapy, Gene Editing
- Active Programs
- 124 confirmed from ClinicalTrials.gov across 51 sponsors
- 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
FDA Inspections4 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2025-08-15)
EMA GMP Certificates11 on record
MHRA GMP Certificates1 on record
Operations
94.5
124 active programs across 51 sponsors
Modalities: Cell Therapy, Gene Editing
81 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov
124 active programs across 51 sponsors · Modalities: Cell Therapy, Gene Editing · 81 programs in advanced phases (Phase 2/3)
Programs
124
Sponsors51
ModalitiesCell Therapy, Gene Editing
124 active programs across 51 sponsors
Modalities: Cell Therapy, Gene Editing
81 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov facility matching
View all 124 programs →
Source: ClinicalTrials.gov · Retrieved Apr 05, 2026
Financial Stability
68.0
Parent company: Bayer AG
Financial assessment: 68.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Parent company: Bayer AG
Financial assessment: 68.0/100
Capacity
58.0
1 manufacturing site: Berkeley, CA
Modalities: Cell Therapy, Gene Editing
Capacity assessment: 58.0/100
Sites: Berkeley, CA
Source: SEC EDGAR, press monitoring, company profiles
1 manufacturing site
1 manufacturing site: Berkeley, CA
Modalities: Cell Therapy, Gene Editing
Capacity assessment: 58.0/100
FDA Inspection History
2025-08
2024-12
2024-11
2024-10
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-08-15 | Whippany, New Jersey | Bioresearch Monitoring | No | No Action Indicated (NAI) |
| 2024-12-17 | Whippany, New Jersey | Bioresearch Monitoring | No | No Action Indicated (NAI) |
| 2024-11-14 | Bergkamen | Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2024-10-30 | Berkeley, California | Blood and Blood Products | No | No Action Indicated (NAI) |
Source: FDA Data Dashboard · Retrieved Apr 05, 2026
EMA GMP Compliance 11 certificates
2025-11
2025-10
2025-10
2025-09
2025-06
2025-05
2025-05
2025-05
2025-04
2025-03
2025-03
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| DE_NW_03_GMP_2026_0015 | Bayer AG | Germany | 2025-11-21 | COMPLIANT |
| DE_TH_01H_GMP_2025_0058 | Bayer Weimar GmbH & Co. KG | Germany | 2025-10-23 | COMPLIANT |
| DE_TH_01H_GMP_2025_0057 | Bayer Weimar GmbH & Co. KG | Germany | 2025-10-23 | COMPLIANT |
| DE_BY_05_GMP_2025_0074 | Blutspendedienst des Bayerischen Roten Kreuzes gGmbH | Germany | 2025-09-03 | COMPLIANT |
| DE_BY_05_GMP_2025_0065 | Blutspendedienst des Bayerischen Roten Kreuzes gGmbH | Germany | 2025-06-05 | COMPLIANT |
| DE_BY_04_GMP_2025_0182 | Blutspendedienst des Bayerischen Roten Kreuzes gGmbH | Germany | 2025-05-15 | COMPLIANT |
| DE_BY_04_GMP_2025_0160 | Bayerische Stammzellbank gGmbH | Germany | 2025-05-14 | COMPLIANT |
| DE_BY_05_GMP_2025_0062 | Blutspendedienst des Bayerischen Roten Kreuzes gGmbH | Germany | 2025-05-09 | COMPLIANT |
| ES/062/25 | Bayer Hispania S.L. | Spain | 2025-04-24 | COMPLIANT |
| FIMEA/2025/001120IMP | Bayer Oy | Finland | 2025-03-28 | COMPLIANT |
| FIMEA/2025/001120 | Bayer Oy | Finland | 2025-03-28 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Apr 05, 2026
MHRA GMP Compliance 1 certificates
2012-06
Compliant
Non-Compliant
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK GMP 32381 Insp GMP 32381/411191-0002[H] | BAYER HEALTHCARE PHARMACEUTICALS | 94608 | 2012-06-18 | COMPLIANT |
Source: MHRA GMDP Database · Retrieved Apr 05, 2026
Clinical Activity 124 studies
NCT07282847
A Study to Evaluate Safety, Tolerability, and Efficacy of AB-1009 Gene...
PHASE1/PHASE2
Recruiting
NCT06944522
A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults...
PHASE3
Recruiting
NCT06914128
A First-in-human Study to Learn How Safe BAY 3713372 is and How it Works in...
PHASE1/PHASE2
Recruiting
NCT06452277
A Study to Learn More About How Well Sevabertinib Works and How Safe it is...
PHASE3
Recruiting
NCT06285643
A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
PHASE2
Recruiting
NCT04777851
Regorafenib-pembrolizumab vs. TACE/TARE in Intermediate Stage HCC Beyond Up-to-7
PHASE3
Terminated
NCT05617885
Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer
PHASE1
Active Not Recruiting
NCT05537740
A First-in-human Study to Learn How Safe the Study Drug BAY3375968, an...
PHASE1
Active Not Recruiting
NCT05236257
A Study Called EPI VITRAKVI to Compare Treatment Results in Patients With...
NA
Completed
NCT04572763
Copanlisib Plus Venetoclax in R/R DLBCL
PHASE1/PHASE2
Active Not Recruiting
NCT04999202
A Study to Learn How Safe the Study Drug BAY 2416964 (AhR Inhibitor) in...
PHASE1
Terminated
NCT04803123
Window Trial to Evaluate Molecular Response to PI3K Inhibition With...
EARLY_PHASE1
Terminated
NCT04879368
RegoNivo vs Standard of Care Chemotherapy in AGOC
PHASE3
Active Not Recruiting
NCT04895579
Lung Cancer With Copanlisib and Durvalumab
PHASE1
Completed
NCT04704154
A Trial to Learn Whether Regorafenib in Combination With Nivolumab Can...
PHASE2
Completed
NCT04476329
Optimization for Regorafenib in HCC
PHASE2
Terminated
NCT04025372
INTREPId (INTermediate Risk Erection PreservatIon Trial)
PHASE2
Active Not Recruiting
NCT04156828
Copanlisib and Combination Chemotherapy for the Treatment of Relapsed or...
PHASE1
Terminated
NCT04233697
Copanlisib in Combination With Romidepsin in Patients With Relapsed or...
PHASE1
Withdrawn
NCT04040725
Rogaratinib for BCG Refractory High Risk Non-Muscle Invasive Bladder Cancer...
PHASE2
Withdrawn
+ 104 more studies
Source: ClinicalTrials.gov · Retrieved Apr 05, 2026
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