Gene Edited Autologous Cell Therapies

Plasmid Engineering

Start strong by designing the right plasmid construct for your gene editing system. Our SnapFast® platform and custom plasmid engineering services help ensure high transgene expression, yield, and control — from CRISPR payloads to viral vector packaging.

With proven expertise in complex genes of interest, we can boost vector yields by up to 3-fold through advanced plasmid optimization.

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Viral Vector Services

We know that Viral Vector is a significant component, and a significant cost element of gene edited autologous cell therapies. We can help not only with scalable manufacturing of AAV and LVV built for gene-modified cell therapy but also help you scale and reduce costs. From plasmid supply to final fill, we support seamless vector production under GMP.

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Cell Therapy Services

Minaris provides comprehensive end-to-end CDMO support for autologous therapies, encompassing process development, GMP manufacturing and global distribution. Our extensive experience in gene-edited autologous CAR-T, TIL, HSC and Treg cells ensures program success. We routinely use state-of-the-art closed and automated manufacturing solutions that help you achieve your goals and commercialize successfully.

During process development (PD) we assess the suitability of current platforms and provide scale-up or scale-out solutions for your Cell Therapy. During this phase we also evaluate all raw materials for GMP use and provide a comprehensive data package for your CMC submissions.

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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 on/off target sequencing analysis 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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Over 25 Years Dedicated to Cell Therapy

Minaris Advanced Therapies has manufactured over 7,500 GMP batches, including genetically engineered T cell products developed using viral and non-viral gene editing platforms.

Our experience spans from early-stage programs to commercial launches, including support for approved therapies. Whether you are using viral vectors, CRISPR/Cas9, TALENs, or other editing technologies, our global teams provide the infrastructure, regulatory expertise, and scientific support to accelerate your path to the clinic and commercialization.

Purpose-Built Platforms for Gene-Modified Therapies

Minaris offers proprietary technologies designed to improve scalability, compliance, and product consistency for gene-edited autologous therapies. Our Closed Process CAR-T Platform provides a proven, GMP-ready foundation for developing and manufacturing CAR-T therapies with greater efficiency and reproducibility. This modular platform integrates automated cell selection, activation, transduction, and expansion, enabling seamless transitions from clinical to commercial scale.

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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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.