Non-Gene Edited Autologous Cell Therapies

Cell Therapy Services

Minaris Advanced Therapies offers end-to-end CDMO support for autologous therapies, from process development through GMP manufacturing and global distribution. Our extensive experience in autologous TIL, HSC, and regenerative medicine cell therapy products ensures program success. We routinely use state-of-the-art closed and automated manufacturing solutions that help you achieve your goals and commercialize successfully. For regenerative medicine products, we have deep process and analytical development expertise that will allow you to manufacture successfully, scale, and reduce COGs.

Minaris Advanced Therapies is the leading CDMO company in TIL cell therapy drug product manufacturing. We are the only CDMO company that manufactures a commercial TIL therapy product. Our teams have processed solid tumors, including melanoma, cervical cancer, lung cancer, renal cancer, and head and neck cancer, either expanding with tumor fragments or expanding with disassociated cells from tumor fragments.

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Testing Services

Robust, scalable, and timely in-process and release testing is a critical element of Autologous Cell Therapy. Through our extensive in-house testing capabilities, we streamline processes so patients receive the therapy safely and quickly. We offer biosafety, identity, potency, stability, and release assays co-located and integrated with manufacturing.

During analytical development (AD) and tech transfer, we evaluate all assays to be scientifically sound and fit-for-purpose. State-of-the-art equipment is used for in-process control testing, as well as future release testing. Surrogate assays for potency assessment and potency assurance programs can be developed concurrently. In-use stability studies or more rapid release methods needed? No problem! Speak with our analytical experts to learn more about our experience and ever-increasing offerings. We can even provide a comprehensive data package for your CMC submission.

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Delivering Personalized Treatments from Patient to Patient

Non-gene edited autologous cell therapies leverage a patient’s own unmodified cells to treat a range of diseases, from regenerative disorders to cancer.

These living medicines require exceptional precision in sourcing, processing, and delivering a viable product back to the same patient within stringent timelines.

Minaris Advanced Therapies has been supporting the development and commercialization of cell therapies for over 25 years. Our teams bring expertise across tumor-infiltrating lymphocytes (TILs), TRCs, natural killer (NK) and Dendritic cells, iPSC, and regenerative medicine therapies, including combination products, with the infrastructure to advance therapies from early-phase trials through patient supply.

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Purpose-Built Platforms for Non-Gene Edited Cell Therapies

Minaris Advanced Therapies offers proprietary technologies designed to improve scalability, compliance and product consistency for non-edited autologous therapies. Our Closed Process platforms provide a proven, GMP-ready foundation for developing and manufacturing multiple autologous therapies with greater efficiency and reproducibility. Our modular platforms integrate automated cell selection, activation and expansion, enabling seamless transitions from clinical trial to patient delivery.

Technologies & Platforms

Explore our suite of enabling technologies to strengthen every stage of your therapy’s lifecycle from payload design and vector production to analytical testing and platform optimization.

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Plasmid Engineering

Design optimized backbones to improve expression, control, and vector performance from day one.
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TESSA® AAV Production Technology

Boost AAV yields while reducing helper virus risk with our helper-free Tessa platform.
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XOFLX™ Lentiviral Packaging & Producer Cell Lines

Accelerate lentiviral development with stable packaging and producer lines built for scale.
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Viral Vector Technologies

Explore vector-specific innovations that improve quality, titer and safety.
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Cell Therapy Technologies

Leverage modular, closed-system solutions for consistent and compliant cell therapy manufacturing.
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Testing Technologies

Enhance product understanding and regulatory readiness with high-sensitivity analytical platforms.

Knowledge Center

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Through our Knowledge Center, we share data-driven insights and best practices from across the industry to help you stay ahead of evolving expectations.

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Contact Us

Minaris Advanced Therapies is dedicated to helping innovators in cell and gene therapy succeed. Whether you are in early-stage development or preparing for commercial launch, our end-to-end expertise, global reach and commitment to quality make us the ideal partner for cell and gene therapy manufacturing and GMP biosafety and analytical testing of all biologics.

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