Bayer (Cell Therapy Mfg)

Berkeley, CA
Cell Therapy Gene Editing
125 confirmed programs · 51 sponsors · Last scored 2026-04-29
71.6
Signal Score
✓ FDA Inspections (7) ✓ Clinical Trials (125) ○ SEC Filings ○ Press ✓ EMA GMP (15) ✓ MHRA GMP (1)

Quick Facts: Bayer (Cell Therapy Mfg)

Signal Score
71.6/100 (as of 2026-04-29)
Quality Compliance
65.0/100 — OAI classification at Cleveland (2025-09-29) — CRITICAL
Headquarters
Berkeley, CA
Modalities
Cell Therapy, Gene Editing
Active Programs
125 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

About Bayer (Cell Therapy Mfg)

CDMO.

Signal Score & Pillar Breakdown

Quality Compliance 65.0
OAI classification at Cleveland (2025-09-29) — CRITICAL
Source: FDA Data Dashboard
OAI classification at Cleveland (2025-09-29) — CRITICAL
FDA Inspections7 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-11-14)
EMA GMP Certificates15 on record
MHRA GMP Certificates1 on record
OAI classification at Cleveland (2025-09-29) — CRITICAL
Operations 94.6
125 active programs across 51 sponsors
Modalities: Gene Editing, Cell Therapy
82 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov
125 active programs across 51 sponsors · Modalities: Gene Editing, Cell Therapy · 82 programs in advanced phases (Phase 2/3)
Programs 125
Sponsors51
ModalitiesCell Therapy, Gene Editing
125 active programs across 51 sponsors
Modalities: Gene Editing, Cell Therapy
82 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov facility matching
NCT07566429 A Study of AB-1005 Gene Therapy in Japanese Adults With... PHASE2 Not Yet Recruiting
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
View all 125 programs →
Source: ClinicalTrials.gov · Retrieved May 20, 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

2025-11
2025-10
2025-09
2025-08
2024-12
2024-11
2024-10
NAI VAI OAI
Date Site Type Observations Classification
2025-11-14 New Castle, Delaware Drug Quality Assurance Yes Voluntary Action Indicated (VAI)
2025-10-20 Whippany, New Jersey Bioresearch Monitoring No No Action Indicated (NAI)
2025-09-29 Cleveland, Mississippi Drug Quality Assurance Yes Official Action Indicated (OAI)
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 May 20, 2026

FDA 483 Findings 7 observations · 2025-09-29 → 2025-11-14 ?

By subsystem

  • Other 2 (28.6%)
  • Equipment & Facilities 2 (28.6%)
  • Laboratory Controls 1 (14.3%)
  • Data Integrity 1 (14.3%)
  • CAPA 1 (14.3%)

By severity

  • 5 — Critical: 1
  • 3 — Moderate: 2
  • 2 — Minor: 4
  • Repeat observations: 0

Most severe findings

  • Critical (5) Data Integrity 2025-09-29 21 CFR 211.68(b)
    Backup data not assured as exact and complete

    "Backup data is not assured as exact, complete and secure from alteration, erasure or loss through keeping hard copy or alternate systems."

  • Moderate (3) Laboratory Controls 2025-09-29 21 CFR 211.160(b)
    Scientifically sound laboratory controls

    "Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that components, drug product containers, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity."

  • Moderate (3) CAPA 2025-09-29 21 CFR 211.192
    Investigations of discrepancies, failures

    "There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed."

About this data →

EMA GMP Compliance 15 certificates

2026-04
2026-04
2026-03
2025-11
2025-10
2025-10
2025-09
2025-06
2025-05
2025-05
2025-05
2025-05
2025-04
2025-03
2025-03
Compliant Non-Compliant
Certificate Site Country Inspection Date Status
DE_BE_01_GMP_2026_0018 Bayer AG Germany 2026-04-22 COMPLIANT
DE_BE_01_GMP_2026_0019 Bayer AG Germany 2026-04-22 COMPLIANT
IT/81/H/2026 Bayer Healthcare Manufacturing S.r.l. Italy 2026-03-20 COMPLIANT
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_2026_0047 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 May 20, 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 May 20, 2026

Clinical Activity 125 studies

NCT07566429 A Study of AB-1005 Gene Therapy in Japanese Adults With Moderate Parkinson's Disease PHASE2 Not Yet Recruiting 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
+ 105 more studies
Source: ClinicalTrials.gov · Retrieved May 20, 2026
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