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Viral Vector Process Development

Translating Discovery into Scalable, GMP-Ready Manufacturing

Minaris partners with innovators to accelerate the development of advanced therapies through fully integrated, regulatory-focused viral vectors platforms spanning viral vectors, cell therapies, and testing. With over 25 years of experience, we bring proven expertise in end-to-end viral vector capabilities.

Our process development teams are dedicated to building scalability, consistency, and compliance into every program, helping therapy developers reduce the cost of goods (COGs) and make vector-based therapies more affordable and accessible.

End-to-End Development Expertise

Our viral vector process development services span the complete pathway from early-stage research through GMP readiness:

Upstream Process Development

Cell line selection and optimization (HEK293, HEK293T, XOFLX™ packaging cell line and stable cell line)

Platform- and vector-specific transfection or infection strategies

Media and feed optimization for maximum productivity

Scalable single-use bioreactor systems up to 200L for development

Downstream Process Development

Purification strategies, including clarification, chromatography and ultrafiltration/diafiltration (UF/DF)

A systematic approach to optimizing recovery, purity and potency

Scalable downstream operations with consistent product quality

Formulation Development

Comprehensive stability-focused buffer and excipient selection

Development of final drug product formulations for both early-phase and late-phase programs

Technology-Enabled Manufacturing Platforms

Our GMP sites are equipped with advanced vector platforms to support scalable and high-quality manufacturing. These technologies can be applied within Minaris Advanced Therapies’ process development programs or as part of standalone GMP manufacturing engagements.

SnapFast™
Plasmids

Customizable, high-performance plasmids engineered for optimal expression and yield

TESSA®
AAV Production

Helper-virus-free system that increases yield up to 30X higher compared to triple plasmid transfection across different serotypes

XOFLX™
Lentiviral
Technology

Stable packaging and producer cell lines for scalable LVV production

Integrated Quality Control and Testing

Co-location of development and QC teams facilitates rapid interaction and knowledge transfer. Our development programs are supported by in-house analytical and testing expertise, ensuring that critical quality attributes (CQAs) are built into your process from the start. Services include:

Assay development, qualification and validation

Potency and infectivity assays

Purity and residuals testing

Stability and viral clearance

Seamless Technology Transfer to GMP Manufacturing

Our process development teams work hand-in-hand with GMP manufacturing operations to ensure smooth technology transfer. We have successfully onboarded and scaled processes from both academic and commercial partners, accelerating time to first GMP batch and minimizing risk.

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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.