Company profile · Bergisch Gladbach, Germany

Miltenyi Biotec

Cell Therapy Platforms and Clinical Manufacturing Tools · Clinical and commercial platform infrastructure

Verified 14 Mar 2026 · 3 sources

Cell TherapyCommercial
GermanyToolsBergisch Gladbach

Clinical cell-processing platform centered on CliniMACS manufacturing suites, MACS analytics, and GMP-ready automation for ATMP workflows.

Lead
Dr. Boris Stoffel (verified ↗)
Compliance
ISO 9001 · ISO 13485
Last reviewed
14 Mar 2026 (3mo ago)
Scale
Clinical and commercial platform infrastructure
Capabilities
Cell Processing Systems · Clinical-Grade Reagents · Immunotherapy Platform Infrastructure
Founded
1989
Headcount
1001-5000
Site and address
Clinical profileSTATUS: VERIFIED MARCH 2026

Dr. Boris Stoffel

Managing Director

Check official leadership source
Full addressFriedrich-Ebert-Straße 68, 51429 Bergisch Gladbach, Germany
Site coordinatesVerification evidence is still being completed.
Review cycleMay 2026
Physical site source

Official Miltenyi Bioindustry imprint page listing Friedrich-Ebert-Straße 68 in Bergisch Gladbach.

Open source
Operating profile

Clinical and commercial platform infrastructure

Bergisch Gladbach, Germany. Cell Therapy Platforms and Clinical Manufacturing Tools. Review completed on 14 Mar 2026.

2026 technical specializationCell Therapy Platforms and Clinical Manufacturing Tools
Core capabilities
Cell Processing SystemsClinical-Grade ReagentsImmunotherapy Platform Infrastructure
Governance

German and EU medical technology oversight

Clinical Manufacturing Platform, ISO 9001, ISO 13485

Editorial note

Cell Therapy Platforms and Clinical Manufacturing Tools

Clinical cell-processing platform centered on CliniMACS manufacturing suites, MACS analytics, and GMP-ready automation for ATMP workflows.

Editorial note

Registry title stays aligned to the current official management documentation, which names Dr. Boris Stoffel in the top operating leadership layer.

FULL TRUST REVIEW COMPLETE
Shown only when all seven trust checks are fully mapped in the directory.
Current review cycleMarch 2026Last reviewed: 14 March 2026
Capabilities

Core capabilities

Primary declared technical activities and areas of operating focus.

Cell Processing Systems
Clinical-Grade Reagents
Immunotherapy Platform Infrastructure
Verification source dossier

Verification source dossier

Official source set used to support leadership, physical-site, certification, and watch-note evidence.

Leadership evidenceMiltenyi Biotec management board page.Source origin: miltenyibiotec.comOpen source
Supporting evidenceMiltenyi Biotec policy document approved by Dr. Boris Stoffel as Managing Director.Source origin: static.miltenyibiotec.comOpen source
Physical-site evidenceOfficial Miltenyi Bioindustry imprint page listing Friedrich-Ebert-Straße 68 in Bergisch Gladbach.Source origin: miltenyibioindustry.comOpen source
Infrastructure

Declared infrastructure

CliniMACS Prodigy systems
MACSQuant analytics
Clinical cell processing suites
Regulatory posture

Quality system coverage

GMP / GLP / ISO-13485 / FDA-Inspected are global quality-system standards. "Verified active" means the directory confirmed the certification is current; "Review in progress" means the cert status is currently being re-verified.

GMP
REVIEW IN PROGRESS 2026
GLP
REVIEW IN PROGRESS 2026
ISO-13485
VERIFIED ACTIVE 2026
FDA-Inspected
REVIEW IN PROGRESS 2026
Verification history

Verification history

14 Mar 2026: Executive identity confirmed via official management disclosure.
14 Mar 2026: Full trust review completed.
FAQ

Frequently asked questions

Where is Miltenyi Biotec located?
Miltenyi Biotec operates from Friedrich-Ebert-Straße 68, 51429 Bergisch Gladbach, Germany, Bergisch Gladbach, Germany.
Who runs Miltenyi Biotec?
Miltenyi Biotec is led by Dr. Boris Stoffel, Managing Director. Verified 14 Mar 2026.
What certifications does Miltenyi Biotec hold?
Miltenyi Biotec is documented under ISO 9001, ISO 13485.
What does Miltenyi Biotec do?
Clinical cell-processing platform centered on CliniMACS manufacturing suites, MACS analytics, and GMP-ready automation for ATMP workflows. Core capabilities: Cell Processing Systems, Clinical-Grade Reagents, Immunotherapy Platform Infrastructure.
Editorial context

Related technical briefs

Briefs that name Bergisch Gladbach as a covered market or city.