Gene Edited Allogeneic Cell Therapies

Plasmid Engineering

Start strong by designing the right plasmid backbone for your gene editing system. Our SnapFast® catalog 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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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 with full characterization, documentation, and integrated release testing.

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Viral Vector Services

Access scalable AAV and LVV manufacturing solutions built for gene-modified cell therapy. 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 allogeneic therapies, encompassing process development, GMP manufacturing and global distribution. Our extensive experience with allogeneic CAR-T, CAR-NK, TCR-T, HSC, MSC, and iPSC-derived immune cells ensures program success. We routinely use off-the-shelf as well as proprietary manufacturing platforms that allow scalability, efficiency and cost reduction, such as 3D suspension and adherent bioreactor-based platforms.

During process development (PD) we assess the suitability of current platforms and provide scale-up or scale-out solutions for your allogeneic 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 allogeneic 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 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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 Advancing Off-the-Shelf Solutions for Global Impact

Gene edited allogeneic cell therapies represent a transformative leap in the fight against cancer, rare diseases and other serious conditions.

By deriving cells from healthy donors and utilizing viral vectors or advanced genome editing tools such as CRISPR/Cas9/Cas12 or TALENs, these therapies are designed to be truly “off-the-shelf,” thereby reducing the time to treatment, reducing COGS and expanding patient access worldwide. Minaris has a wealth of experience in scaling and manufacturing both adherent and suspension-based Allogeneic therapies with multiple cell types, from MSC to Immune cells and iPSC.

Purpose-Built Platforms for Gene-Modified Therapies

Gene editing allogeneic cell therapies is a challenging and at-times, expensive proposition. At Minaris, we offer proprietary technologies designed to improve scalability, compliance, and product consistency for gene-edited allogeneic therapies. Our experience with 2D and 3D manufacturing platforms, together with our deep gene editing experience with viral vectors, electroporation and other solutions, drive the success of your therapy.

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.