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Cell and gene therapy solutions

Whatever your CGT vision is, we are by your side – from early discovery to commercialization

Advancing the field of cell and gene therapy is at the heart of Miltenyi Biotec. For more than three decades, we have helped basic researchers, clinical investigators, and biopharmaceutical companies to discover and harness the power of immune cells for cellular therapies.

With our expertise in providing reagents, instruments, and services from research to clinical-grade, we are unique in enabling investigators to take early discoveries to clinical translation and commercial manufacturing.  Whether your interest lies in immuno-oncology, regenerative medicine, or graft engineering, you’ll find comprehensive solutions to support a variety of cell manufacturing procedures.

Our expertise in cell and gene therapy 

Where are you heading to?

Cell and gene therapies are revolutionizing medicine today and are a big promise for the future. Our cutting-edge technologies, workflows, and raw materials help you to design and enhance the body's immune system for efficient targeting. No matter where your journey begins – at the research bench, or on a translational or commercial level – take advantage of our broad CGT portfolio and take your next step.   

Clinical-scale cell manufacturing

Standardization has become key for reliable and consistent cell manufacturing. By leveraging our automated, closed-system cell processing platform, the CliniMACS Prodigy®, we set the bar for high quality standardized cell manufacturing. Our platform enables consistent and scalable GMP-compliant manufacturing on a single device and within a single process setup.

Learn more about theCliniMACS Prodigy Platform

 

In-process and quality control

Flow cytometry is used in cell therapy 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® Analyzer Platform is the perfect combination to be used in cell manufacturing, with tailored analytical features such as automated PMT calibration, compensation, staining, and harmonized instrument settings across multiple devices and sites.

Learn more about Cell and gene therapy analytics

GMP-compliant cell sorting

Some cells are rare and often need pre-enrichment steps using multiparametric cell sorting. Our MACSQuant® Tyto® Cell Sorter was the first in the market to provide GMP-compliant cell sorting.

Learn more about the MACSQuant Tyto

 

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The CliniMACS Prodigy T Cell Transduction Process – A complete manufacturing solution

The CliniMACS Prodigy T Cell Transduction (TCT) Process provides a unique all-in-one solution for the complex manufacturing process of engineered T cells . The CliniMACS Prodigy Platform enables the generation of gene-modified T cells in a standardized and fully automated way. It is a breakthrough in cell manufacturing, a leap to the next generation of engineered cell manufacturing.

Our cell and gene therapy services 

Customized cell manufacturing applications on the CliniMACS Prodigy Platform 

Customized Application (CAP) Service for the CliniMACS Prodigy Platform offers the translation of manual manufacturing processes into tailor-made, automated, GMP-compliant procedures. Our team of specialists configure and align predefined software modules in accordance with customer specifications. 

CliniMACS Cell Factory®

Translating CGT manufacturing processes to commercial-scale production capacities is challenging. However, the CliniMACS Cell Factory capitalizes on the automated, closed-system cell processing of the CliniMACS Prodigy Platform. It reduces cleanroom requirements and enables scalable, parallel manufacturing of clinical cell products on multiple instruments – in one room. With our MACSQuant Flow Cytometer Platform we’ve added tailored and automated analytical tools for effective IPC/QC to your cell manufacturing workflow. Whatever your CGT vision is, we make sure you get there. 

CDMO services to realize your cell and gene therapy program – Miltenyi Bioindustry

One of the biggest challenges in the cell and gene therapy field is finding the safest and most unobstructed path from pre-investigational new drug (IND) activities to commercialization. Overcoming the high-risk gaps caused by unknowns related to process and platform, missing expertise, and an evolving regulatory landscape is key for success.    
Our Miltenyi Bioindustry team is your CDMO partner from therapeutic development to GMP lentiviral vector manufacturing and cell therapy production. We provide completely integrated solutions carefully engineered for unique cell therapies with gene therapy workflows. We deliver a seamless clinical experience with access to our cutting-edge technologies and resources for IND clearance and beyond.

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Customized application service for CliniMACS Prodigy

Take advantage of tailor-made solutions on the CliniMACS Prodigy.