Miltenyi Biotec

Bergisch Gladbach, Germany
CAR-T Cell Therapy
8 confirmed programs · 8 sponsors · Last scored 2026-04-02
73.0
Signal Score
○ FDA Inspections ✓ Clinical Trials (8) ○ SEC Filings ✓ Press (3) ✓ EMA GMP (2) ○ MHRA GMP

Quick Facts: Miltenyi Biotec

Signal Score
73.0/100 (as of 2026-04-02)
Quality Compliance
100.0/100 — No FDA inspection records found for this manufacturer
Headquarters
Bergisch Gladbach, Germany
Modalities
CAR-T, Cell Therapy
Active Programs
8 confirmed from ClinicalTrials.gov across 8 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 100.0
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Source: FDA Data Dashboard
No FDA inspection records found for this manufacturer · Quality score requires FDA inspection data
FDA InspectionsNo US records on file
EMA GMP Certificates2 on record
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Operations 57.5
8 active programs across 8 sponsors
Modalities: Cell Therapy, CAR-T
2 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov
8 active programs across 8 sponsors · Modalities: Cell Therapy, CAR-T · 2 programs in advanced phases (Phase 2/3)
Programs 8
Sponsors8
ModalitiesCAR-T, Cell Therapy
8 active programs across 8 sponsors
Modalities: Cell Therapy, CAR-T
2 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov facility matching
NCT07192900 Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease PHASE1 Recruiting
NCT05705570 Clinical Trial Using CAR- T Cells for Treatment of Patients... PHASE1 Recruiting
NCT05094206 CAR20.19.22 T-cells in Relapsed, Refractory B-cell Malignancies PHASE1 Terminated
NCT05281809 Local Manufacture of CAR T-Cell Products for the Treatment of... PHASE2 Recruiting
NCT04464434 Upfront Autologous HSCT Versus Immunosuppression in Early... PHASE4 Completed
NCT01033617 IMPACT-CABG Trial: IMPlantation of Autologous CD133+ sTem... NA Completed
NCT00595127 Hematopoietic Stem Cell Transplantation for Treatment of... NA Completed
NCT01881334 Expanded Access to T-cell Depleted Haplo-Identical Stem Cells... NA Available
Source: ClinicalTrials.gov · Retrieved Apr 05, 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 58.0
1 manufacturing site: Bergisch Gladbach, DE
Modalities: CAR-T, Cell Therapy
Capacity assessment: 58.0/100
Sites: Bergisch Gladbach, DE
Source: SEC EDGAR, press monitoring, company profiles
1 manufacturing site
Recent Press3 articles
1 manufacturing site: Bergisch Gladbach, DE
Modalities: CAR-T, Cell Therapy
Capacity assessment: 58.0/100

EMA GMP Compliance 2 certificates

2025-06
2024-09
Compliant Non-Compliant
Certificate Site Country Inspection Date Status
DE_NW_04_GMP_2025_0046 Miltenyi Biotec B.V. & Co. KG Germany 2025-06-18 COMPLIANT
DE_MV_01_GMP_2025_0017 Miltenyi Biotec B.V. & Co. KG Germany 2024-09-19 COMPLIANT
Source: EMA EudraGMDP · Retrieved Apr 05, 2026

Recent News 3 articles

general 2026-02-23
Miltenyi Biotec sprints for the CAR-T finish line amid rising Big Pharma consolidation - ET Pharma
Miltenyi Biotec sprints for the CAR-T finish line amid rising Big Pharma consolidation  ET Pharma
Source →
general 2026-02-20
Miltenyi Biotec weighs local CGT manufacturing, eyes export potential - Business Standard
Miltenyi Biotec weighs local CGT manufacturing, eyes export potential  Business Standard
Source →
regulatory 2026-02-20
Miltenyi Biotec sees big India opportunity as it advances Made‑for‑India CAR‑T therapies - Moneycontrol.com
Miltenyi Biotec sees big India opportunity as it advances Made‑for‑India CAR‑T therapies  Moneycontrol.com
Source →
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