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XOFLX™ Lentiviral Packaging & Producer Cell Lines

A New Era for Lentiviral Vector Manufacturing

Lentiviral vectors (LVVs) are a workhorse of modern gene-modified therapies, powering CAR-T, TCR-T, NK and iPSC-based platforms. Yet, traditional transient transfection methods can face significant barriers, including high costs, poor scalability, lengthy development timelines and variable yields.

XOFLX™, Minaris’ proprietary lentiviral packaging and producer cell line platforms, solves these challenges. By stably integrating packaging functions into the producer cell line, either partially (packaging) or fully (producer), XOFLX™ reduces or eliminates the need for plasmid transfection. The result is a productive, stable and scalable system that delivers reproducible LVV supply at an industrial scale, with reduced costs of goods and lower risk.

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Industry Bottlenecks in LVV Production

These bottlenecks have hindered the broader adoption of LVV-based therapies in larger patient populations and in vivo applications. Developers working with transient transfection face well-documented obstacles:

Low yields and variability

Often in the range of 106–107 TU/mL, with as much as ±50% batch-to-batch variation

Long optimization cycles

The process of developing adjustments for optimization can take up to 6 to 9 months

Scale-up failures

Conditions that work well at the shake-flask scale may fail when scaled up to 50–200 liters

Regulatory uncertainty

Evolving guidelines around residual DNA, host cell proteins and potency assays

High cost of goods

Industry benchmarks indicate $1–2 million per GMP batch, compounded by limited manufacturing capacity

How XOFLX™ Works

XOFLX™ cell lines integrate LV packaging functions into the host cell genome. This approach stabilizes productivity, shortens process development timelines and provides a consistent path from preclinical supply to commercial-scale manufacturing.

Packaging Cell Lines

Provide key helper functions stably through induction, lowering plasmid burden and making the transfection process easier.

Producer Cell Lines

Incorporate all necessary
components, eliminating plasmid transfection entirely.

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Transient Transfection vs XOFLX™

Transient Transfection
XOFLX™ Platform

Production Method

Requires 4 plasmids per batch

Single plasmid transfection in Packaging lines; no plasmids needed for producer lines

Yield Consistency

106–107 TU/mL, ±50% variability

Comparable/ higher titers than 4-plasmid production; reduced batch-to-batch variability

Scalability

Struggles above 50–200L

The producer cell line has potential for >1000 L production

Cost of Goods

$1M–2M per GMP batch

Lower, due to reduced plasmid requirement and greater efficiency

Timeline

6–9 month optimization cycles

Faster path due to the lower complexity of the production

Custom XOFLX™ Cell Line Development

Minaris offers tailored programs to create packaging or producer lines that meet client-specific therapeutic needs.

Services include:

  • Stable integration of packaging components, including therapeutic-specific envelop gene
  • Stable integration of therapeutic transgenes
  • Clone selection and productivity screening
  • Assay development to evaluate potency, residuals and safety
  • Transition from preclinical banks to GMP-compliant Master Cell Banks
Project timelines are structured to accelerate progress from early development to LVV GMP manufacturing, derisking commercialization.
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Applications Across Modalities

  • Autologous CAR-T and TCR-T therapies need a consistent LVV supply for cell transduction

  • Allogeneic NK and iPSC-based platforms, where scalability is essential

  • in vivo gene therapies requiring lower cost-of-goods and industrial-scale production capacity

Why XOFLX™ Matters for Biotech Innovators

As the field expands into more prevalent indications, demand for cost-effective, large-scale LVV production is rising. XOFLX™ delivers a platform designed to keep pace with clinical and commercial needs by:

  • Unlocking true scalability
  • Reducing cost and complexity
  • Enhancing reproducibility
  • Supporting a wide range of therapeutic platforms
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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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