Global facilities
Division Miltenyi Bioindustry, Bergisch Gladbach
Miltenyi Biotec B.V. & Co. KG
Friedrich-Ebert-Str. 68
51429 Bergisch Gladbach, Germany
Division Miltenyi Bioindustry, San Jose
Miltenyi Biotec, Inc.
2825 N 1st St.
San Jose, CA 95134, USA
Division Miltenyi Bioindustry, Gaithersburg
Miltenyi Biotec North America – US Headquarters
1201 Clopper Road
Gaithersburg, MD 20878, USA
Division Miltenyi Bioindustry, Shanghai
Miltenyi Biotec Technology & Trading (Shanghai) Co., Ltd.
1077 Zhangheng Road
Pudong New Area, 201203 Shanghai, P.R. China
Division Miltenyi Bioindustry, Teterow
Miltenyi Biotec B.V. & Co. KG
Robert-Koch-Str. 1
17166 Teterow, Germany
Bergisch Gladbach
Division Miltenyi Bioindustry, Bergisch Gladbach
Miltenyi Biotec B.V. & Co. KG
Friedrich-Ebert-Str. 68
51429 Bergisch Gladbach, Germany
San Jose
Division Miltenyi Bioindustry, San Jose
Miltenyi Biotec, Inc.
2825 N 1st St.
San Jose, CA 95134, USA
Gaithersburg
Division Miltenyi Bioindustry, Gaithersburg
Miltenyi Biotec North America – US Headquarters
1201 Clopper Road
Gaithersburg, MD 20878, USA
PuDong
Division Miltenyi Bioindustry, Shanghai
Miltenyi Biotec Technology & Trading (Shanghai) Co., Ltd.
1077 Zhangheng Road
Pudong New Area, 201203 Shanghai, P.R. China
Teterow
Division Miltenyi Bioindustry, Teterow
Miltenyi Biotec B.V. & Co. KG
Robert-Koch-Str. 1
17166 Teterow, Germany
Leveraging our global presence
With a global presence and a flexible infrastructure that enables us to accommodate the changing needs of our customers, we can support virtually any type of project you bring us. Our strategically located GMP cell manufacturing facilities in the US, Europe, and Asia, are well situated to support your local needs in many regions. Close proximity to key markets supports logistical and operational continuity.
All our manufacturing sites follow the same CliniMACS Cell Factory® standards. They are all equipped with our CliniMACS Prodigy® Platform Technology, which allows automated, standardizable, closed-system cell manufacturing. Another part of these standards is our tailored MACSQuant® Analyzer Flow Cytometry Platform with automated features for customized IPC/QC. Our lentiviral vector manufacturing platform is based on the latest lentiviral vector technologies, where our proven, scalable system delivers consistently high-quality vectors to support your therapeutical pipeline goals.
North America
San Jose, CA (US)
2825 N 1st St., San Jose, CA 95134
52,000 ft² (~5,000 m²)
Key facts:
• CliniMACS Cell Factory
• Multiple ISO 6/Grade B clean room suites
• Process development labs, QC labs
Core competencies:
• Cell therapy process development
• Clinical cell therapy manufacturing
• Analytical assay development
• Tech transfer
• Regulatory support
Gaithersburg, MD (US)
1201 Clopper Road, Gaithersburg, MD 20878
143,500 ft² (~13,000 m²)
Key facts:
• Multiple ISO 6/Grade B clean room suites
• Lentiviral vector manufacturing platform
• R&D labs, QC labs, support areas
Core competencies:
• Vector design, evaluation, and selection through commercial manufacturing support
• Preclinical and GMP-grade lentiviral vector manufacturing
• Commercial manufacturing
• Regulatory support
Europe
Bergisch Gladbach (Germany)
Friedrich-Ebert-Str. 68, 51429 Bergisch Gladbach
Key facts:
• CliniMACS Cell Factory
• Multiple ISO 6/Grade B clean room suites
• Process development labs, QC labs
Core competencies:
• Plasmid manufacturing for vector production
• Cell therapy process development
• Clinical cell therapy manufacturing
• Analytical assay development
• Tech transfer
• Regulatory support
• Late-phase process industrialization
Teterow (Germany)
Robert-Koch-Str. 1, 17166 Teterow
Key facts:
• Lentiviral vector manufacturing platform
• Multiple ISO 7/Grade C clean room suites
Core competencies:
• Preclinical and GMP-grade lentiviral vector manufacturing
• Commercial manufacturing
Asia Pacific
Shanghai (China)
1077 Zhangheng Road, Pudong New Area, 201203 Shanghai, P.R. China
Key facts:
• CliniMACS Cell Factory
• ISO 7/Grade C clean room suite
Core competencies:
• Cell therapy process development
• Technology and analytical method transfer
• Regulatory support
High quality standards and regulatory compliance
- Our facilities have been audited and accepted by many large pharma/biotech companies and are licensed for investigational drug manufacturing or CAR T cell manufacturing
- Documented quality control and quality assurance processes to certify the release of safe, consistent, and potent cell and gene therapy and lentiviral vector products
- GMP-compliant quality system