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
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 Works and... 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 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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