Takeda

Boston, MA · Zurich, CH

Hybrid — also manufactures internal programs

AAV Cell Therapy

99 confirmed programs · 26 sponsors · Last scored 2026-04-02

80.7

Signal Score

✓ FDA Inspections (2) ✓ Clinical Trials (99) ○ SEC Filings ✓ Press (2) ✓ EMA GMP (11) ○ MHRA GMP

Quick Facts: Takeda

Signal Score: 80.7/100 (as of 2026-04-02)
Quality Compliance: 99.8/100
Headquarters: Boston, MA · Zurich, CH
Modalities: AAV, Cell Therapy
Active Programs: 99 confirmed from ClinicalTrials.gov across 26 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

FDA Inspections2 on record

Warning Letters0

Last InspectionVoluntary Action Indicated (VAI) (2025-11-12)

EMA GMP Certificates11 on record

Operations

99 active programs across 26 sponsors · Modalities: AAV, Cell Therapy · 66 programs in advanced phases (Phase 2/3)

Programs 99

Sponsors26

ModalitiesAAV, Cell Therapy

99 active programs across 26 sponsors

Modalities: AAV, Cell Therapy

66 programs in advanced phases (Phase 2/3)

Source: ClinicalTrials.gov facility matching

NCT07224100 Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib... PHASE2 Recruiting

NCT07422480 A Study to Compare Elritercept With Epoetin Alfa to Treat... PHASE3 Recruiting

NCT06980480 A Study of Gammagard Liquid (Immune Globulin Infusion, 10%)... PHASE3 Recruiting

NCT07217301 IBI363 vs Docetaxel in Patients With Advanced Squamous Lung... PHASE3 Recruiting

NCT07205718 A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors PHASE1/PHASE2 Recruiting

NCT06377228 A Study of TAK-007 in Adults With Refractory Lupus Nephritis... PHASE1 Withdrawn

NCT06588868 Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma NA Recruiting

NCT06677892 A Study of Maribavir in Adults With Post-transplant... NA Recruiting

NCT06615921 A Study of Maribavir in Adults With Post-transplant... NA Completed

NCT05952804 IVIG for Infection Prevention After CAR-T-Cell Therapy PHASE2 Recruiting

View all 99 programs →

Source: ClinicalTrials.gov · Retrieved Apr 05, 2026

Financial Stability

Profile-based financial assessment

SEC FilingsPrivate company

Private company

Financial assessment: 60.0/100

Capacity

2 manufacturing sites

Recent Press2 articles

2 manufacturing sites

FDA Inspection History

2025-11

2024-10

NAI VAI OAI

Date	Site	Type	Observations	Classification
2025-11-12	Singen (Hohentwiel)	Drug Quality Assurance	No	Voluntary Action Indicated (VAI)
2024-10-16	Cambridge, Massachusetts	Bioresearch Monitoring	No	No Action Indicated (NAI)

Source: FDA Data Dashboard · Retrieved Apr 05, 2026

EMA GMP Compliance 11 certificates

2025-12

2025-11

2025-07

2025-02

Compliant Non-Compliant

Certificate	Site	Country	Inspection Date	Status
CRN00GT94_M00807/00001	Takeda Ireland Limited	Ireland	2025-12-12	COMPLIANT
CRN00GT94_ IMP00002/00001	Takeda Ireland Limited	Ireland	2025-12-12	COMPLIANT
DE_BB_01_GMP_2025_0046	Takeda GmbH	Germany	2025-11-28	COMPLIANT
DE_BW_01_GMP_2026_0012	Takeda GmbH	Germany	2025-11-12	COMPLIANT
36209/M00807/00002	Takeda Ireland Limited	Ireland	2025-07-11	COMPLIANT
36209/ASR11355/00001	Takeda Ireland Limited	Ireland	2025-07-11	COMPLIANT
483038-104067091	Takeda Manufacturing Austria AG	Austria	2025-07-04	COMPLIANT
483034-103627593	Takeda Manufacturing Austria AG	Austria	2025-07-04	COMPLIANT
483039-103639089	Takeda Manufacturing Austria AG	Austria	2025-07-04	COMPLIANT
IT-API/20/H/2025	Takeda Manufacturing Italia S.p.A.	Italy	2025-02-14	COMPLIANT
484005-103627759	Takeda Austria GmbH	Austria	2025-02-14	COMPLIANT