Bayer (Cell Therapy Mfg)

Berkeley, CA
Cell Therapy Gene Editing
124 confirmed programs · 51 sponsors · Last scored 2026-03-15
63.0
Signal Score
✓ FDA Inspections (4) ✓ Clinical Trials (124) ○ SEC Filings ○ Press

Quick Facts: Bayer (Cell Therapy Mfg)

Signal Score
63.0/100 (as of 2026-03-15)
Quality Compliance
Assessment pending
Headquarters
Berkeley, CA
Modalities
Cell Therapy, Gene Editing
Active CGT 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 CGT manufacturing 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 Inspections4 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2025-08-15)
Operations —
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs 124
Sponsors51
ModalitiesCell Therapy, Gene Editing
124 active programs across 51 sponsors
Modalities: Gene Editing, Cell Therapy
81 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov facility matching
NCT07282847 A Study to Evaluate Safety, Tolerability, and Efficacy of... PHASE1/PHASE2 Recruiting
NCT06944522 A Study to Investigate the Efficacy and Safety of... PHASE3 Recruiting
NCT06914128 A First-in-human Study to Learn How Safe BAY 3713372 is and... PHASE1/PHASE2 Recruiting
NCT06452277 A Study to Learn More About How Well Sevabertinib (BAY... PHASE3 Recruiting
NCT06285643 A Study of AAV2-GDNF in Adults With Moderate Parkinson's... PHASE2 Recruiting
NCT04777851 Regorafenib-pembrolizumab vs. TACE/TARE in Intermediate Stage... 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... PHASE1 Active Not Recruiting
NCT05236257 A Study Called EPI VITRAKVI to Compare Treatment Results in... NA Completed
NCT04572763 Copanlisib Plus Venetoclax in R/R DLBCL PHASE1/PHASE2 Active Not Recruiting
View all 124 programs →
Source: ClinicalTrials.gov · Retrieved Mar 20, 2026
Financial Stability 68.0
Parent company: Bayer AG
Financial assessment: 68.0/100
Source: SEC EDGAR, press monitoring
Subsidiary of Bayer AG
SEC FilingsParent: Bayer AG
Parent company: Bayer AG
Financial assessment: 68.0/100
Capacity 58.0
1 CGT 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 CGT manufacturing site
1 CGT 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 Mar 20, 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 (BAY 2927088) Works and... 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 Mar 20, 2026
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