Global CDMO services for cell and gene therapy

Global CDMO services for cell and gene therapy

We are your premier CDMO partner from therapeutic development to GMP cell and lentiviral vector 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. Together, we build tailored, lasting, turnkey solutions to strengthen clinical programs en route to advanced therapy success. 

 

Our CDMO services

Cell process development and manufacturing

Our services are based on our own innovative Miltenyi Biotec products, years of experience, and our enthusiasm for developing the perfect 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. 

  • Strategic consultation & clinical manufacturing strategy planning
    • Review and translation planning
  • Transfer and process automation
    • Translation of research processes including GMP-supportive Customized Application (CAP) services
  • Process industrialization and analytics
    • Process development and analytical suite development
  • Early product characterization
    • Product characterization and potency assay development
  • GMP-compliant manufacturing
    • Scalable GMP manufacturing and cell product release
  • Process characterization and validation
    • Process performance qualification, process and assay validation

 Supporting your clinical journey from development to commercial launch.

Discovery and Feasibility StudiesProcess DevelopmentIND-Enabling StudiesClinical StudiesCommercial Launch
• Translation of research processes into automated cleanroom-suitable processes 
• Optimization of design of experiment-based parameters 
• Strategic consultation, e.g., COGS analysis and clinical manufacturing strategy planning 
• Tech transfer of late phase, well- developed processes (if applicable)
• Manufacturing process development and optimization 
• Analytical development of in-process and final product release test methods, including characterization and potency assays 
• Final product transport evaluation
• Process and assay qualifications 
• Creation of cell therapy product material for in vivo toxicology studies 
• Stability studies 
• Engineering runs 
• Aseptic process simulation qualification
• GMP-grade cell manufacturing and record keeping 
• Release testing 
• Management of third-party testing services 
• Global regulatory support
• Support commercial manufacturing 
• Technology transfer to designated facility (if applicable)

Lentiviral vector optimization and manufacturing

We provide high-quality lentiviral vector manufacturing services for the entire research and development cycle. 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 proven, customizable, and commercially viable vector system that’s designed to enhance clinical translation and further standardize the manufacture of unique cell therapies.

  • Vector design, evaluation, and selection
    • Consultation and feasibility testing
  • Small-scale evaluation
  • GMP-compliant manufacturing
    • Mid- to large-scale GMP vector manufacturing and release
  • Process characterization and validation
    • Process performance qualification, process and assay validation
  • Commercial manufacturing of lentiviral vector
    • Full support in late-stage and commercial manufacturing

Leverage our lentiviral vector platform from development to commercialization.

Construct DevelopmentProcess DevelopmentIND-Enabling StudiesClinical StudiesCommercial Launch
• Vector design, synthesis, and cloning 
• Vector evaluation and feasibility testing 
• Deliverable: 2 mL non-purified vector
• Purified vector batch 
In vitro evaluation 
• Production scale: 4 L 
• Deliverable: 30–35 mL purified vector
• Pre-clinical, purified vector batch 
In vivo evaluation 
• Production scale: 50–200 L 
• Deliverable: 300 –1,800 mL purified vector
• Clinical-grade master cell bank and plasmid 
• GMP-release testing 
• Stability studies 
• Global regulatory support 
• Production scale: 50–200 L 
• Deliverable: 300–1,800 mL GMP-grade vector
• Process scale-up, characterization, and validation 
• Process performance qualification and assay validation 
• Production scale: 200 L 
• Deliverable: 1,600–1,800 mL commercial-grade vector

Add-on services

We aim to make sure that each technical gap is bridged to simplify your clinical journey. In addition to our cell and lentiviral vector services, we offer full support across our development and manufacturing sites and outside organizations. We prioritize the engineering and seamless continuation of successful manufacturing processes with our network and our technology. We also provide phase-appropriate, regional regulatory support by leveraging our years of experience working in conjunction with different regulatory bodies worldwide.

  • Global and country-specific regulatory support 
  • Tech transfer to contract manufacturing organization (CMO) 
  • Contract testing organization (CTO) support 
  • Product stability 
  • Late-phase process industrialization 

Brochure
Cell and Gene Therapy Development and Manufacturing

Seamless support along the critical path

 

Why Miltenyi Biotec?

Proven solutions carefully engineered for unique cell and gene therapies

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. Today, we are known worldwide for our unparalleled commitment to innovation and technical excellence. We rely on our own time-tested technologies and resources to develop, optimize, and engineer robust GMP-compliant cell manufacturing processes that are specifically tailored to our customers’ cell therapy needs. 

To date, we have served as a trusted partner for many cell manufacturing companies in all phases of clinical progression – from small preclinical 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
San Jose Facility Lead / Senior Director of Process Sciences, Miltenyi Biotec

Proven clinical expertise in cell 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
  • >40 products certified as medical devices within the EU
  • Certified as manufacturer of medical devices within the EU and for MDSAP countries
 

Our technology

For high quality GMP-compliant 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.     

Video
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 

Manufacturing sites

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.
  • Our proprietary lentiviral vector system utilizes a third generation SIN vector construct, designed to enhance clinical translation capabilities.
  • Documented quality control and quality assurance processes to certify the release of safe, consistent, and potent cell therapy and lentiviral vector products.
  • Our facilities have been audited and accepted by large pharma/biotech companies and are licensed for investigational drug manufacturing (San José) or generic CAR T cell manufacturing (Bergisch Gladbach).
 

Speak to an expert

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