Takeda

Boston, MA · Zurich, CH
Hybrid — also manufactures internal programs
AAV Cell Therapy
99 confirmed programs · 26 sponsors · Last scored 2026-04-29
79.6
Signal Score
✓ FDA Inspections (3) ✓ Clinical Trials (99) ○ SEC Filings ✓ Press (7) ✓ EMA GMP (15) ○ MHRA GMP

Quick Facts: Takeda

Signal Score
79.6/100 (as of 2026-04-29)
Quality Compliance
96.7/100
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

About Takeda

Hybrid developer + CDMO.

Signal Score & Pillar Breakdown

Quality Compliance 96.7
FDA Inspections3 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-11-12)
EMA GMP Certificates15 on record
Operations 84.7
99 active programs across 26 sponsors
Modalities: AAV, Cell Therapy
66 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov
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
NCT07422480 A Study to Compare Elritercept With Epoetin Alfa to Treat... PHASE3 Recruiting
NCT07224100 Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib... PHASE2 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 PHASE1 Withdrawn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 May 20, 2026
Financial Stability 60.0
Private company
Financial assessment: 60.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Private company
Financial assessment: 60.0/100
Capacity 63.0
2 manufacturing sites
Sites: Boston, MA, Zurich, CH
Source: SEC EDGAR, press monitoring, company profiles
2 manufacturing sites
Recent Press7 articles
2 manufacturing sites

FDA Inspection History

2025-11
2025-09
2024-10
NAI VAI OAI
Date Site Type Observations Classification
2025-11-12 Singen (Hohentwiel) Drug Quality Assurance No Voluntary Action Indicated (VAI)
2025-09-26 Hauppauge, New York Drug Quality Assurance Yes Voluntary Action Indicated (VAI)
2024-10-16 Cambridge, Massachusetts Bioresearch Monitoring No No Action Indicated (NAI)
Source: FDA Data Dashboard · Retrieved May 20, 2026

FDA 483 Findings 1 observations · 2025-09-26 → 2025-09-26 ?

By subsystem

  • Documentation & Records 1 (100.0%)

By severity

  • 2 — Minor: 1
  • Repeat observations: 0

Most severe findings

  • Minor (2) Documentation & Records 2025-09-26 21 CFR 211.22(d)
    Procedures not in writing, fully followed

    "The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed."

About this data →

EMA GMP Compliance 15 certificates

2026-03
2026-03
2026-02
2026-02
2025-12
2025-12
2025-11
2025-11
2025-07
2025-07
2025-07
2025-07
2025-07
2025-02
2025-02
Compliant Non-Compliant
Certificate Site Country Inspection Date Status
483038-105130824 Takeda Manufacturing Austria AG Austria 2026-03-20 COMPLIANT
483039-104783268 Takeda Manufacturing Austria AG Austria 2026-03-20 COMPLIANT
480001-104799057 Takeda Manufacturing Austria AG Austria 2026-02-26 COMPLIANT
CRN00GXFQ/M12976 Takeda Pharmaceuticals International AG Ireland Branch Ireland 2026-02-11 COMPLIANT
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
Source: EMA EudraGMDP · Retrieved May 20, 2026

Clinical Activity 99 studies

NCT07422480 A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults... PHASE3 Recruiting NCT07224100 Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the... PHASE2 Recruiting NCT06980480 A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent... PHASE3 Recruiting NCT07217301 IBI363 vs Docetaxel in Patients With Advanced Squamous Lung Cancer After... 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 (LN) or... 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 Cytomegalovirus (CMV)... NA Recruiting NCT06615921 A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection NA Completed NCT05952804 IVIG for Infection Prevention After CAR-T-Cell Therapy PHASE2 Recruiting NCT05718297 Brigatinib Post Definitive Chemo-radiotherapy in Patients with ALK-fusion... PHASE2 Withdrawn NCT05748197 A Study of ADCLEC.syn1 in People With Acute Myeloid Leukemia PHASE1 Recruiting NCT05886478 A Study in Adults With Cutaneous T-cell Lymphoma (CTCL) Retreated With... NA Completed NCT05737849 A Study to Learn About the Tests Looking for a Gene Mutation in Adults With... NA Withdrawn NCT05721950 A Study to Learn About Brigatinib Treatment Information Available in Chinese... NA Active Not Recruiting NCT05319353 A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and... PHASE3 Recruiting NCT05886491 A Study of GDX012 in Adults With Relapsed or Refractory Acute Myeloid Leukemia PHASE1/PHASE2 Terminated NCT05571137 A Study on Cytomegalovirus (CMV) Infection Outcomes Among Hematopoietic Stem... NA Completed NCT05735327 A Study of Brigatinib as Preferred First Therapy for Adults With Non-Small... NA Active Not Recruiting NCT05757700 Study of 19(T2)28z1xx TRAC-Chimeric Antigen Receptor (CAR) T Cells in People... PHASE1 Active Not Recruiting
+ 79 more studies
Source: ClinicalTrials.gov · Retrieved May 20, 2026

Recent News 7 articles

general 2026-05-05
Second life for a gene therapy; Takeda passes Phase 2/3 test; UK cancer biotech's $83M raise - Endpoints News
Second life for a gene therapy; Takeda passes Phase 2/3 test; UK cancer biotech's $83M raise  Endpoints News
Source →
general 2026-04-26
Takeda walks away from cell therapy in priority U-turn - MSN
Takeda walks away from cell therapy in priority U-turn  MSN
Source →
general 2026-04-25
Takeda walks away from cell therapy in priority U-turn - MSN
Takeda walks away from cell therapy in priority U-turn  MSN
Source →
general 2026-04-25
Takeda walks away from cell therapy in priority U-turn - MSN
Takeda walks away from cell therapy in priority U-turn  MSN
Source →
general 2026-04-10
Fierce Pharma Asia—Takeda-Denali split-up; Merck, Zhifei's revised deal; Shionogi's made-in-US plan - Fierce Pharma
Fierce Pharma Asia—Takeda-Denali split-up; Merck, Zhifei's revised deal; Shionogi's made-in-US plan  Fierce Pharma
Source →
general 2026-03-18
Sandoz expands biosim collab with Samsung Bioepis, sets sights on Takeda's Entyvio - Fierce Pharma
Sandoz expands biosim collab with Samsung Bioepis, sets sights on Takeda's Entyvio  Fierce Pharma
Source →
general 2026-02-26
A rare approach to a rare disease: Infant botulism | Takeda Stories - Takeda Pharmaceuticals
A rare approach to a rare disease: Infant botulism | Takeda Stories  Takeda Pharmaceuticals
Source →
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