Comprehensive solutions for your cell and gene therapy development 

Your full-service partner for cell processing and manufacturing

Miltenyi Biotec, a pioneer in the field of cell and gene therapy technologies, provides an array of comprehensive and innovative products and services capable of supporting a diverse range of cellular therapeutic approaches. Leverage our decades of research, clinical, and regulatory expertise and resources to accelerate the development and commercialization of your next generation therapies. 

  • Process development/optimization and CDMO services to accelerate your IND filings and clinical trial manufacturing
  • GMP cell manufacturing services from Phase I trials through commercial launch
  • GMP manufacturing of lentiviral vectors
  • Single-use GMP disposables for the lowest contamination risk
  • Experienced global regulatory support to simplify your regulatory applications

CDMO Services

For over 25 years, Miltenyi Biotec has played a central role within the cellular research and therapy community. We utilize our time-proven technology and resources to develop, optimize, and engineer robust GMP cell manufacturing processes that are specifically tailored to our customers’ cell therapy needs.  

Our flexible infrastructure enables us to change and expand to accommodate the needs of our customers from small pre-clinical scale up to commercial scale. Alternatively, we can transfer our technical know-how to enable in-house manufacturing of your own therapy. Applying our expertise in customizing and automating cellular production to your cell manufacturing processes will accelerate your programs towards the clinic. Furthermore, with strategically located GMP cell manufacturing facilities in the US and Europe, we are well situated to support your needs in many regions. 

• Process development and cellular product manufacturing using our scalable and automated CliniMACS-based technologies for clinical trials and commercial uses. 
• US and European-based GMP manufacturing facilities enabling close logistical proximity to key markets and operational continuity. 
• Quality control and quality assurance systems to certify the release of safe, consistent and potent cell therapy products. 
• Segregated GMP Controlled Environment Room (CER), ISO 7 suites with separate air handlers and terminal HEPA filters. 
• Registered with FDA for human cells and tissues product (HCT/P) processing and licensed by the state of California for investigational drug manufacturing. 
• Global regulatory support.
With a proven suite of cell therapy-focused instruments and reagents, Miltenyi Biotec has a strong reputation in the cell therapy field supplying GMP-enabling products to all areas of the cellular therapy industry. To date, these products and services have been used to treat more than 50,000 patients.
 In addition, we harness the power of lentiviral gene delivery and expression technology for a wide variety of biotechnology and clinical applications in our Lentigen facility. Our experts oversee industry-leading design, construction, and production of lentiviral vectors, along with expertise to support the  successful translation of gene therapy strategies into the clinic. 

Lentiviral Products and Services

Lentigen Technology, Inc., a Miltenyi Biotec company, is experienced in lentiviral vector development and manufacturing for clinical applications. The depth and breadth of the experience of the Lentigen team dates back to the first lentiviral vector clinical trials in humans where team members played an instrumental role. Lentigen offers a comprehensive portfolio of products and services, including:
 • Extensive experience in lentiviral vector design and construction 
• Proven lentiviral vector system used in a wide range of clinical trials. 
• Optimized lentiviral backbones to enable enhanced targeting, transduction and payload expression. 
• Access to our unmatched intellectual property portfolio. 
• Scalable, serum-free suspension lentiviral vector production from milliliter scale research grade to 200 liters commercial scale. 

• GMP ISO 7 suites with separate air handling systems that meet US and EU GMP requirements. 
• Regulatory support throughout the application and filing process with Biologics Master File available in the U.S. for cross-referencing.

Whether you are in early-stage strategy development, or you are looking for ways to power up your innovation to commercial-scale production, the Miltenyi Biotec CDMO team is here to help.  Our experts in Sunnyvale, CA, and Gaithersburg, MD, are ready to work as your strategic partner to get you started and bring your projects over the finish line.

 

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