Miltenyi Biotec

Bergisch Gladbach, DE
CAR-T Cell Therapy
8 confirmed programs · 8 sponsors · Last scored 2026-03-15
59.0
Signal Score
○ FDA Inspections ✓ Clinical Trials (8) ○ SEC Filings ✓ Press (6)

Quick Facts: Miltenyi Biotec

Signal Score
59.0/100 (as of 2026-03-15)
Quality Compliance
Assessment pending
Headquarters
Bergisch Gladbach, DE
Modalities
CAR-T, Cell Therapy
Active CGT 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 CGT manufacturing intelligence platform

Signal Score & Pillar Breakdown

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
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Operations —
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs 8
Sponsors8
ModalitiesCAR-T, Cell Therapy
8 active programs across 8 sponsors
Modalities: CAR-T, Cell Therapy
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 Recruiting
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 Mar 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 58.0
Regulatory milestones (4 articles)
Sites: Bergisch Gladbach, DE
Source: SEC EDGAR, press monitoring, company profiles
1 CGT manufacturing site
Recent Press6 articles
Regulatory milestones (4 articles)

Recent News 6 articles

regulatory 2026-03-09
Leading India’s Cell and Gene Therapy Journey: Dr Priya Kapoor G Hingorani on Women in Biotech - IndiaMedToday
Leading India’s Cell and Gene Therapy Journey: Dr Priya Kapoor G Hingorani on Women in Biotech  IndiaMedToday
Source →
regulatory 2026-03-01
“Asia is a growth engine, and India is a cornerstone of that strategy — both as a destination for advanced therapies and as a contributor to global innovation” - BioSpectrum Asia
“Asia is a growth engine, and India is a cornerstone of that strategy — both as a destination for advanced therapies and as a contributor to global innovation”  BioSpectrum Asia
Source →
regulatory 2026-03-01
“Asia is a growth engine, and India is a cornerstone of that strategy — both as a destination for advanced therapies and as a contributor to global innovation” - BioSpectrum Asia
“Asia is a growth engine, and India is a cornerstone of that strategy — both as a destination for advanced therapies and as a contributor to global innovation”  BioSpectrum Asia
Source →
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 →
Represent this organization? Contact us to verify or update this profile.
See all CDMOs in:
CAR-T CDMOs → Cell Therapy CDMOs →