Global CDMO services for cell and gene therapy

Global CDMO services for cell and gene therapy

Miltenyi Bioindustry is your CDMO partner from therapeutic development to GMP lentiviral vector and cell therapy manufacturing. We provide completely integrated solutions carefully engineered for unique cell therapies with gene therapy workflows. We deliver a seamless clinical experience with exclusive access to our cutting-edge technologies and resources for investigational new drug (IND) clearance.

One of the biggest challenges in the cell and gene therapy field is finding the safest and most unobstructed path from pre-IND activities to commercialization. Overcoming the high-risk gaps caused by unknowns related to process and platform, the market, and an evolving regulatory landscape is key for success.  

Focusing on clinical and commercial readiness, our team of process and analytical experts leverages the power and capabilities of the latest Miltenyi Biotec technology. We have decades of experience in lentiviral vector design, process development, GMP manufacturing and a broad range of clinically relevant applications in cell processing. We provide customized solutions that will successfully speed you through IND submissions and beyond. Together, we build tailored, lasting, turnkey solutions to strengthen clinical programs en route to advanced therapy success. 

Miltenyi Bioindustry

Visit our Miltenyi Bioindustry website to learn more about our CDMO services. 

 

Our CDMO services

Lentiviral vector optimization and manufacturing

We provide high-quality lentiviral vector manufacturing services for the entire research and development cycle to commercialization. Our state-of-the-art lentiviral vector backbone construct and platform process allows for rapid evaluation, development and scale-up and has been successfully leveraged in numerous clinical trials. We provide extensive process knowledge and a customizable, and commercially viable vector system that’s designed to enhance clinical translation and further standardize the manufacture of unique cell therapies.

Our lentiviral vector services at a glance

  • Vector design, evaluation, and selection
    • Consultation and feasibility testing
  • Small-scale evaluation
  • Clinical vector manufacturing
    • Mid- to large-scale GMP vector manufacturing and release
  • Commercial manufacturing of lentiviral vector
    • Full support in late-stage and commercial manufacturing

Cell process development and manufacturing for clinical use

Our services are based on our own innovative Miltenyi Biotec products, years of experience, and our enthusiasm for developing the cell product together with our customers. We are by your side from pre-clinical to commercial launch and facilitate a smooth ride through all phases of your clinical journey. 

Our cell and gene therapy services at a glance

  • Strategic consultation & clinical manufacturing strategy planning
    • Review and translation planning
  • Analytical assay development
    • Product characterization and potency assay development
  • Cell therapy process development
    • Translation of research processes into automated platform
    • Customized Application (CAP) services
  • Clinical cell therapy manufacturing
    • Scalable GMP manufacturing and cell product release
    • Process characterization and validation
  • Commercial launch support
    • Tech transfer to contract manufacturing organization (CMO) 
    • Global service and training programs
    • Support of your own facility expansion to meet space, equipment, and staffing requirements

Regulatory services

We aim to make sure that each technical gap is bridged to simplify your clinical journey. In addition to our lentiviral vector and cell processing services, we offer regulatory support across all development and manufacturing stages. Make use of our phase-appropriate, regional regulatory support by leveraging our many years of experience working in conjunction with different regulatory bodies worldwide.

Our regulatory services at a glance

  • Our global quality and regulatory teams support your project at every stage – from pre-IND to marketing authorization
  • We look back on 30 years of experience in more than 50 countries
  • Our regulatory support covers lentiviral vectors, in cell and gene therapy, and our MACS® GMP Products
  • Contract testing organization (CTO) support 
 

Why Miltenyi Bioindustry?

Proven solutions carefully engineered for unique cell and gene therapy services

For more than 30 years, Miltenyi Biotec has played an important role in the advancement of biomedical research and enablement of cell and gene therapy. As a division of Miltenyi Biotec, Miltenyi Bioindustry relies on these time-tested technologies and resources to develop, optimize, and produce GMP-compliant vectors and cell therapy products.  

To date, we have served as a trusted partner for many cell manufacturing companies in all phases of clinical progression – from small pre-clinical testing and scale-up, to commercial-scale operations. We have developed products and services that have been used to treat more than 50,000 patients.  

We have an excellent track record going where all of our clients’ IND applications have been cleared. A large part of that is due to our primary focus on IND-enabling activities.
Ian Gaudet, PhD
Senior Director and Site Head of San Jose Facility, Miltenyi Bioindustry

Proven clinical expertise in cell and gene therapy applications

  • >500 supported IND/investigation device exemptions (IDE) applications in the US
  • >150 clinical studies outside the US
  • >30 Type II Drug Master Files on file with the US FDA
 

Our technologies

For high quality GMP-enabling cell processing we count on our own instruments, disposables and MACS® GMP Products. Our products are developed and optimized for use in clinical cell manufacturing and for many years provided excellent cell products to the field. With our holistic approach we cover a broad range of times tested cell manufacturing applications and are experts in streamlining customized clinical workflows and IPC/QC testing.

CliniMACS Prodigy

The CliniMACS® Prodigy Platform 

The CliniMACS Prodigy Platform is the centerpiece of our idea of GMP-compliant cell production and genetic engineering. It allows for automated end-to-end closed system processes, fully customizable and easy to up-scale. The platform integrates all process steps including cell washing, selection, activation, transduction, and harvest.. With additional modules like the CliniMACS® Electroporator, automated transfection expands cell engineering possibilities. The CliniMACS® Formulation Unit guarantees safe final formulation and filling. In addition to our instruments and expertise, we provide all reagents, buffers, and media. This single-source model helps to reduce regulatory complexities.

MACSQuant Flow Cytometer Platform

MACSQuant® Flow Cytometer Platform

Flow cytometry is the most widely used modality in cell therapy, employed to determine incoming product phenotype and composition for in-process control, as well as to evaluate cellular identity and purity of final drug products for release testing. Our MACSQuant Flow Cytometer Platform is the perfect combination to be used in cell manufacturing with tailored analytical tools such as automated calibration, compensation, staining, and harmonized instrument settings across multiple devices and sites. 

The customizable Express Mode software on our MACSQuant Analyzers allows fully automated sample acquisition, data analysis, and reporting. Our platform offers a streamlined development paradigm, and ultimately, a faster path to commercialization.

CliniMACS Cell Factory 

The CliniMACS Cell Factory® 

The CliniMACS Cell Factory capitalizes on the automated, closed system cell processing of the CliniMACS Prodigy Platform to reduce cleanroom requirements and enables parallel manufacturing of clinical cell products on multiple instruments – in one room.    

No matter if small-scale or large-scale manufacturing is in focus, our standards can be tailored to any vision. All our cell manufacturing locations are built and equipped on the same principle. Our uniform facility design is the basis for consistent manufacturing and analytical processes worldwide. Furthermore, it clearly decreases the challenges that come with process up- and out-scaling. As we solely rely on our own high quality ancillary materials, we are independent of external supply chains and product variations. This lowers regulatory hurdles and accelerates process development.     

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The CliniMACS Cell Factory – Clinical-scale manufacturing of cell and gene therapy products

The CliniMACS Cell Factory brings clinical-scale cell manufacturing to the next level. Our scalable, automated and closed system cell processing platform reduces cleanroom requirements and enables parallel manufacturing of patient material on multiple instruments – in one room.

 

Our development and manufacturing sites 

Global facilities

As a truly international company 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 needs in many regions. Close proximity to key markets guarantees logistical and operational continuity. Ask how our experts can assist your scale-out visions.

High quality standards

  • All sites are equipped with our CliniMACS Prodigy Platform Technology, which allows for automated, standardizable, closed-system cell manufacturing.
  • Documented quality control and quality assurance processes to certify the release of safe, consistent, and potent lentiviral vector and cell therapy products.
  • Our facilities have been audited and accepted by large pharma/biotech companies and are licensed for investigational drug manufacturing (San José) or received generic CAR T cell manufacturing (Bergisch Gladbach).

Visit our Miltenyi Bioindustry website and speak to an expert

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