Bayer (Cell Therapy Mfg)

Berkeley, CA

Profile last updated: 2026-03-21

Cell Therapy Gene Editing

No confirmed program data — ClinicalTrials.gov verification pending · Last scored 2026-09-07

80.4

Signal Score

✓ FDA Inspections (6) ✓ Clinical Trials (126) ○ SEC Filings ○ Press ✓ EMA GMP (10) ✓ MHRA GMP (1)

Quick Facts: Bayer (Cell Therapy Mfg)

Signal Score: 80.4/100 (as of 2026-09-07)
Quality Compliance: 90.1/100
Headquarters: Berkeley, CA
Modalities: Cell Therapy, Gene Editing
Active Programs: Data pending
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

Scores are being republished. Scores are being republished under methodology v3.3. The score shown is the last complete v3.2 result, which is also what directory listings and search results show. A pillar breakdown is not shown because the current one is computed under v3.3 and would not explain a v3.2 score. Regulatory evidence below is current.

Quality Compliance

FDA Inspections6 on record

Warning Letters0

Last InspectionNo Action Indicated (NAI) (2026-05-22)

EMA GMP Certificates10 on record

MHRA GMP Certificates1 on record

Operations

Programs — no verified data

Sponsors— no verified data

ModalitiesCell Therapy, Gene Editing

Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.

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 Study of PRMT5 Inhibitor BAY 3713372 in Participants With... PHASE1/PHASE2 Recruiting

NCT06789445 A Study to Investigate the Safety of OpCT-001 in Adults Who... 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 Completed

NCT05537740 A First-in-human Study to Learn How Safe the Study Drug... PHASE1 Active Not Recruiting

View all 126 programs →

Source: ClinicalTrials.gov · Retrieved Oct 07, 2026

Financial Stability

Profile-based financial assessment

SEC FilingsPrivate company

Capacity

Profile-based capacity assessment

Bayer (Cell Therapy Mfg) FDA Inspection History

2026-05

2025-10

2025-08

2024-12

2024-11

2024-10

NAI VAI OAI

Date	Site	Type	Observations	Classification
2026-05-22	Bayer HealthCare LLC Myerstown, Pennsylvania Facility-linked	Drug Quality Assurance	No	No Action Indicated (NAI)
2025-10-20	Bayer Healthcare Pharmaceuticals Inc. Whippany, New Jersey Facility-linked	Bioresearch Monitoring	No	No Action Indicated (NAI)
2025-08-15	Bayer Healthcare Pharmaceuticals Inc. Whippany, New Jersey Facility-linked	Bioresearch Monitoring	No	No Action Indicated (NAI)
2024-12-17	Bayer Healthcare Pharmaceuticals Inc. Whippany, New Jersey Facility-linked	Bioresearch Monitoring	No	No Action Indicated (NAI)
2024-11-14	Bayer AG Bergkamen Facility-linked	Drug Quality Assurance	No	Voluntary Action Indicated (VAI)
2024-10-30	Bayer HealthCare, LLC Berkeley, California Facility-linked	Blood and Blood Products	No	No Action Indicated (NAI)

Source: FDA Data Dashboard · Retrieved Oct 07, 2026

Attribution not established (9)

These records are excluded from this company’s established evidence because their attribution is unresolved. This describes an evidence-linking limitation, not an assessment of the underlying regulatory findings.

Source	Establishment named by the regulator	Location	Identifier
FDA inspection	Marlex Pharmaceuticals, Inc.	New Castle, Delaware	FDA/FEI=1000121454
FDA inspection	Baxter Healthcare Corporation	Cleveland, Mississippi	FDA/FEI=1019003
EMA GMP certificate	Blutspendedienst des Bayerischen Roten Kreuzes gGmbH	Nuremberg	EMA_OMS/OMS_LOCATION_ID=LOC-100032730
EMA GMP certificate	Blutspendedienst des Bayerischen Roten Kreuzes gGmbH	Wiesentheid	EMA_OMS/OMS_LOCATION_ID=LOC-100032731
EMA GMP certificate	Blutspendedienst des Bayerischen Roten Kreuzes gGmbH	Munich	—
EMA GMP certificate	Blutspendedienst des Bayerischen Roten Kreuzes gGmbH	Munich	—
EMA GMP certificate	Blutspendedienst des Bayerischen Roten Kreuzes gGmbH	Munich	EMA_OMS/OMS_LOCATION_ID=LOC-100032729
EMA GMP certificate	Bayerische Stammzellbank gGmbH	Gauting	EMA_OMS/OMS_LOCATION_ID=LOC-100028704
EMA GMP certificate	Blutspendedienst des Bayerischen Roten Kreuzes gGmbH	Wuerzburg	—

Source records retained verbatim · attribution not established

Bayer (Cell Therapy Mfg) EMA GMP Compliance 10 certificates

2026-04

2026-03

2025-11

2025-10

2025-04

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_NW_03_GMP_2026_0054	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
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