Miltenyi Biotec’s CliniMACS Prodigy® Automates TIL Expansion, Paving Way for Scalable Cancer Immunotherapy

August 9, 2026

Bioprocess Online Germany

Overview

Miltenyi Biotec is advancing the automated expansion of tumor-infiltrating lymphocytes (TILs) using its GMP-compliant CliniMACS Prodigy® platform. This system addresses critical challenges in scaling up TIL manufacturing for cancer immunotherapy by providing a standardized, automated workflow. The ultimate goal is to efficiently and consistently produce high-quality, uniform TILs for clinical application, making effective immunotherapy accessible to more cancer patients.

In Depth

Background

Tumor-infiltrating lymphocyte (TIL) therapy is a type of adoptive cell immunotherapy where T cells harvested from a patient’s own tumor are expanded ex vivo and re-administered to attack cancer cells. Significant clinical efficacy has been reported, particularly for solid tumors like melanoma. However, the process from TIL collection to expansion and formulation is highly individualized, requiring profound technical expertise and stringent quality control. Automated platforms, such as those offered by companies like Miltenyi Biotec, are thus indispensable for resolving these manufacturing challenges and accelerating the dissemination of this promising therapy.

Key Findings

Miltenyi Biotec has successfully achieved automated expansion of tumor-infiltrating lymphocytes (TILs) using its GMP (Good Manufacturing Practice)-compliant integrated cell processing system, the CliniMACS Prodigy® platform. This advancement represents a critical milestone in overcoming challenges related to quality consistency and scalability, which are major bottlenecks in TIL manufacturing for cancer immunotherapy.

The CliniMACS Prodigy® is a sophisticated closed and automated system designed to perform various cell separation, washing, culture, and expansion protocols. Specifically for TIL therapy, it enables the isolation of TILs from patient-derived tumor tissue and their selective expansion with high purity. Traditional TIL expansion processes are highly manual, time-consuming, labor-intensive, and carry inherent risks of batch-to-batch variability and contamination. Automation with CliniMACS Prodigy® offers significant improvements through:

Standardized Workflow: All steps are automated and executed according to predefined protocols, eliminating operator-dependent variability and ensuring product consistency.
Maintenance of Sterility: Processing occurs within a fully closed system, minimizing the risk of external microbial contamination and enhancing product safety.
Efficient Scale-Up: Automated culture management features allow for larger-scale cell expansion, facilitating the transition to clinical and commercial production.

This innovation is crucial for making TIL therapy, which has shown very promising therapeutic effects for some solid tumors, more widely accessible. By enabling the provision of high-quality, cost-effective TILs, the technology directly improves treatment accessibility for a greater number of patients. Automated TIL expansion technology using the CliniMACS Prodigy® platform is expected to bring revolutionary progress to the field of cancer immunotherapy. Widespread adoption of this technology could significantly reduce TIL therapy manufacturing costs, shorten time-to-treatment, and ultimately enable more cancer patients to access this promising therapeutic option. Further technological development is also anticipated to enhance TIL functionality and targeting capabilities, potentially expanding therapeutic efficacy against a broader range of solid tumors.

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