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Cell Line Development

Build Stable, Scalable Cell Lines for Vectors, Proteins and Advanced Therapies

Minaris designs and develops research, production and platform cell lines that are stable, high-performing and ready to scale. We engineer lines for producing viral vectors and recombinant proteins.

High-throughput clone screening is employed to maximize the chances of obtaining a clone with the desired level of performance. We test such performance using predictive small-scale bioreactors and processes to de-risk the scale-up process. Each selected clone is rigorously characterized to ensure compliance with regulatory guidelines.

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What We Develop

We generate non-engineered and engineered monoclonal lines with full traceability and create research and master cell banks. Programs span HEK293 families, CHO and other hosts, with animal-component-free and defined media. Our suspension HEK293 lines have been proven to produce viral vectors at high titer, with Drug Master File (DMF) support available for select lines.

Engineering Strategies

Our team tailors gene-of-interest integration methods to your program goals. These approaches enable rapid creation of stable pools, followed by single-cell isolation and clonal selection.

Non-viral approaches, such as transposon systems and plasmid-based random integration, enable high-copy, stable integration.

Viral vector approaches with retroviral or lentiviral vectors to modify dividing or non-dividing cells

Knock-out and knock-in using gene editing tools for precise modifications

Construct design support from our plasmid engineering team to optimize promoters and regulatory elements

Discover XOFLX™ for Lentiviral Vectors

For lentiviral vectors, Minaris offers XOFLX™ packaging and producer lines that reduce or eliminate the need for plasmid transfection. The platform delivers consistent titers, improved safety profiles and scalability to industrial volumes, outperforming transient transfection approaches.

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Monoclonality, Screening and Predictive Analytics

We use automated liquid handling and high-resolution imaging to confirm single-cell origin, monitor colony growth and document clonality. Each project includes a comprehensive clonality package with traceability tables and ISO-aligned, release-ready reports.

Once clonal lines are established, they undergo high-throughput screening in scaled-down bioreactor systems, which accurately predict performance at larger volumes. Analytical assays, including STR profiling, karyotyping, and integration site sequencing, assess cell line stability, integrity and productivity. Combining proof of origin with predictive analytics allows for the most robust candidates to advance to banking and GMP manufacturing.

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Quality and Documentation

Our cell line development services are designed to deliver cell lines for R&D applications, as well as cGMP manufacturing platforms for your product. All our projects are ISO-compliant and follow a rigid documentation methodology to provide a fully traceable process.

From cell line modification and clone screening to characterization and stability testing, the process is discussed with the customer, customized and documented. The full documentation package includes clonality reports, traceability tables and a report of testing results performed for each cell bank.

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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.

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