Miltenyi Biotec
Bergisch Gladbach, DE
8 confirmed programs
· 8 sponsors
· Last scored 2026-04-29
74.6
Signal Score
○ FDA Inspections
✓ Clinical Trials (8)
○ SEC Filings
✓ Press (16)
✓ EMA GMP (2)
○ MHRA GMP
Quick Facts: Miltenyi Biotec
- Signal Score
- 74.6/100 (as of 2026-04-29)
- Quality Compliance
- 100.0/100 — No FDA inspection records found for this manufacturer
- Headquarters
- Bergisch Gladbach, DE
- 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
About Miltenyi Biotec
Pure-play CDMO.
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: CAR-T, Cell Therapy
2 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov
8 active programs across 8 sponsors · Modalities: CAR-T, Cell Therapy · 2 programs in advanced phases (Phase 2/3)
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
Partnership Announcements (from press monitoring)
CHA Biotech, Miltenyi Biotec collaborate on scalable CAR-NK manufacturing - koreabiomed.com
2026-04-28
Cha Biotech partners with Miltenyi Biotec to advance CAR-NK therapy in Korea - CHOSUNBIZ - Chosunbiz
2026-04-28
Cha Biotech Partners With Miltenyi Biotec to Develop Allogeneic CAR-NK Cancer Therapy - aju press
2026-04-28
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
66.0
Strong partnership activity (6 articles)
Regulatory milestones (7 articles)
Sites: Bergisch Gladbach, DE
Source: SEC EDGAR, press monitoring, company profiles
1 manufacturing site
Recent Press16 articles
Strong partnership activity (6 articles)
Regulatory milestones (7 articles)
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 May 20, 2026
Clinical Activity 8 studies
NCT07192900
Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease
PHASE1
Recruiting
NCT05705570
Clinical Trial Using CAR- T Cells for Treatment of Patients With Refractory...
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 B-Cell...
PHASE2
Recruiting
NCT04464434
Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous...
PHASE4
Completed
NCT01033617
IMPACT-CABG Trial: IMPlantation of Autologous CD133+ sTem Cells in Patients...
NA
Completed
NCT00595127
Hematopoietic Stem Cell Transplantation for Treatment of Patients With...
NA
Completed
NCT01881334
Expanded Access to T-cell Depleted Haplo-Identical Stem Cells for Patients...
NA
Available
Source: ClinicalTrials.gov · Retrieved May 20, 2026
Recent News 16 articles
GMP Cytokines Market Key Players | Miltenyi Biotec, ABCAM, Akron Biotech, REPROCELL Inc etc. - openPR.com
GMP Cytokines Market Key Players | Miltenyi Biotec, ABCAM, Akron Biotech, REPROCELL Inc etc. openPR.com
CHA Biotech, Miltenyi Biotec collaborate on scalable CAR-NK manufacturing - koreabiomed.com
CHA Biotech, Miltenyi Biotec collaborate on scalable CAR-NK manufacturing koreabiomed.com
Cha Biotech partners with Miltenyi Biotec to advance CAR-NK therapy in Korea - CHOSUNBIZ - Chosunbiz
Cha Biotech partners with Miltenyi Biotec to advance CAR-NK therapy in Korea - CHOSUNBIZ Chosunbiz
Cha Biotech Partners With Miltenyi Biotec to Develop Allogeneic CAR-NK Cancer Therapy - aju press
Cha Biotech Partners With Miltenyi Biotec to Develop Allogeneic CAR-NK Cancer Therapy aju press
Cha Biotech partners with Miltenyi Biotec to advance CAR-NK therapy in Korea - CHOSUNBIZ - Chosunbiz
Cha Biotech partners with Miltenyi Biotec to advance CAR-NK therapy in Korea - CHOSUNBIZ Chosunbiz
Miltenyi Biotec and CHA Biotech collaborate on BaEV lentiviral vector platform - Manufacturing Chemist
Miltenyi Biotec and CHA Biotech collaborate on BaEV lentiviral vector platform Manufacturing Chemist
Miltenyi Biotec and CHA Biotech collaborate on BaEV lentiviral vector platform - Manufacturing Chemist
Miltenyi Biotec and CHA Biotech collaborate on BaEV lentiviral vector platform Manufacturing Chemist
BIRAC in pact with Miltenyi Biotec India to boost India's capabilities in cell & gene therapy - MSN
BIRAC in pact with Miltenyi Biotec India to boost India's capabilities in cell & gene therapy MSN
BIRAC in pact with Miltenyi Biotec India to boost India's capabilities in cell & gene therapy - MSN
BIRAC in pact with Miltenyi Biotec India to boost India's capabilities in cell & gene therapy MSN
BIRAC in pact with Miltenyi Biotec India to boost India's capabilities in cell & gene therapy - MSN
BIRAC in pact with Miltenyi Biotec India to boost India's capabilities in cell & gene therapy MSN
BIRAC in pact with Miltenyi Biotec India to boost India's capabilities in cell & gene therapy - MSN
BIRAC in pact with Miltenyi Biotec India to boost India's capabilities in cell & gene therapy MSN
BIRAC in pact with Miltenyi Biotec India to boost India's capabilities in cell & gene therapy - MSN
BIRAC in pact with Miltenyi Biotec India to boost India's capabilities in cell & gene therapy MSN
BIRAC in pact with Miltenyi Biotec India to boost India's capabilities in cell & gene therapy - MSN
BIRAC in pact with Miltenyi Biotec India to boost India's capabilities in cell & gene therapy MSN
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
Miltenyi Biotec weighs local CGT manufacturing, eyes export potential - Business Standard
Miltenyi Biotec weighs local CGT manufacturing, eyes export potential Business Standard
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
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