Takara Bio

Kusatsu, Shiga Prefecture, Japan

Profile last updated: 2026-07-11

CAR-T Lentiviral

1 partnership announcement in press monitoring · Last scored 2026-09-07

57.9

Signal Score

○ FDA Inspections ✓ Clinical Trials (8) ○ SEC Filings ✓ Press (16) ○ EMA GMP ○ MHRA GMP

Quick Facts: Takara Bio

Signal Score: 57.9/100 (as of 2026-09-07)
Quality Compliance: Assessment pending
Headquarters: Kusatsu, Shiga Prefecture, Japan
Modalities: CAR-T, Lentiviral
Active Programs: Data pending
Data Sources: FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
Scored By: CDMO Signal — independent CDMO intelligence platform

About Takara Bio

Pure-play 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 —

No FDA inspection records found. This CDMO may operate under a different legal name or may not have US FDA-inspected facilities.

FDA InspectionsNo US records on file

Operations

Programs — no verified data

Sponsors— no verified data

ModalitiesCAR-T, Lentiviral

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

Partnership Announcements (from press monitoring)

Takara Bio USA, Inc. Collaborates with Illumina on Spatial Transcriptomics Workflow, Details Presented at AGBT 2026 - BioSpace

2026-02-26

NCT07174427 Multi-center Study of TBI-1301 (INN: Mipetresgene Autoleucel;... PHASE3 Recruiting

NCT05963217 Study of TBI-2001(Autologous CD19 Specific Chimeric Antigen... PHASE1 Recruiting

NCT03250325 Study of TBI-1301 (NY-ESO-1 T Cell Receptor Gene Transduced... PHASE1/PHASE2 Completed

NCT03155191 Study of TBI-1501 for Relapsed or Refractory Acute... PHASE1/PHASE2 Active Not Recruiting

NCT02418598 AADC Gene Therapy for Parkinson's Disease PHASE1/PHASE2 Terminated

NCT02366546 Investigator Initiated Phase 1 Study of TBI-1301 PHASE1 Unknown

NCT02134262 Gene Therapy for B-Cell Non-Hodgkin Lymphoma Using CD19 CAR... PHASE1/PHASE2 Unknown

NCT02096614 Investigator Initiated Phase 1 Study of TBI-1201 PHASE1 Completed

Source: ClinicalTrials.gov · Retrieved Oct 07, 2026

Financial Stability

Profile-based financial assessment

SEC FilingsPrivate company

Capacity

Profile-based capacity assessment

Recent Press16 articles

Clinical Activity 8 studies

NCT07174427 Multi-center Study of TBI-1301 (INN: Mipetresgene Autoleucel; Mip-cel) in... PHASE3 Recruiting NCT05963217 Study of TBI-2001(Autologous CD19 Specific Chimeric Antigen Receptor (CAR)... PHASE1 Recruiting NCT03250325 Study of TBI-1301 (NY-ESO-1 T Cell Receptor Gene Transduced Autologous T... PHASE1/PHASE2 Completed NCT03155191 Study of TBI-1501 for Relapsed or Refractory Acute Lymphoblastic Leukemia PHASE1/PHASE2 Active Not Recruiting NCT02418598 AADC Gene Therapy for Parkinson's Disease PHASE1/PHASE2 Terminated NCT02366546 Investigator Initiated Phase 1 Study of TBI-1301 PHASE1 Unknown NCT02134262 Gene Therapy for B-Cell Non-Hodgkin Lymphoma Using CD19 CAR Gene Transduced... PHASE1/PHASE2 Unknown NCT02096614 Investigator Initiated Phase 1 Study of TBI-1201 PHASE1 Completed

Source: ClinicalTrials.gov · Retrieved Oct 07, 2026

Recent News 16 articles

general 2026-05-04

AI in Plasmid DNA Manufacturing Market Is Going to Boom| Roche, Takara Bio, Agilent Technologies - openPR.com

AI in Plasmid DNA Manufacturing Market Is Going to Boom| Roche, Takara Bio, Agilent Technologies  openPR.com