Non-Gene Edited Allogeneic Cell Therapies

Cell Banking

Establish robust, regulatory-ready master (MCB) and working cell banks (WCB) (e.g. for MSC). Our global facilities support GMP-compliant cell banking, providing full characterization, documentation and integrated release testing.

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Cell Therapy Services

Minaris Advanced Therapies provides comprehensive end-to-end CDMO solutions for allogeneic therapies, encompassing process and analytical development services, GMP manufacturing and global distribution. Our extensive experience spans MSC, iPSC, Immune cells, and more. We have deep experience with scalable solutions for diverse process requirements. Whether you are using large-scale 2D solutions such as cell factories, or micro-carrier/suspension stir-tank bioreactors, we will help you develop, scale, manufacture and commercialize your allogeneic cell therapy.

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Testing Services

Robust, scalable and timely in-process and release testing is a critical element of Cell Therapy. Through our extensive in-house testing capabilities, we streamline processes so patients can 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 also provide a comprehensive data package for your CMC submission.

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Advancing Off-the-Shelf Cell Therapies with Proven Expertise

Minaris Advanced Therapies supports the development and GMP manufacturing of non-gene edited allogeneic cell therapies designed to be delivered “off the shelf” to multiple patients from a single or multiple donor sources.

These therapies include mesenchymal stem/stromal cells (MSC/MPC), natural killer (NK) cells, hematopoietic cells, induced pluripotent stem cells (iPSCs), and other immune or progenitor cell types. These programs require rigorous donor qualifications, robust process development and scalable manufacturing platforms to ensure consistent performance, potency and safety.

Our global facilities and closed-system manufacturing expertise enable efficient production and long-term supply of allogeneic therapies, from preclinical development through commercialization. We partner with you to optimize cell banking, cell activation, expansion and cryopreservation processes while meeting regulatory requirements across global markets.

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Purpose-Built Platforms for Non-Gene Edited Cell Therapies

At Minaris, we offer off-the-shelf as well as proprietary technologies designed to improve scalability, compliance, and product consistency of allogeneic therapies. Our deep experience with developing and scaling 2D and 3D manufacturing platforms is unparalleled. Our closed-system platforms offer GMP-ready foundations for donor-derived therapies, enabling expansion and cryopreservation. These modular solutions streamline transitions from early-phase trials to global commercialization.

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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