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Product

Supercoiled minicircle DNA. Cell-free. Backbone-optional.

Lead with the molecular quality. Best for cell/gene therapy and vaccine sponsors evaluating the therapeutic DNA on regulatory and immunogenicity terms.

  • Cell-free
    enzymatic
  • Supercoiled
    mcDNA
  • ~1.5-week mfg. TAT
  • Grams to kilograms

Program delays

Why bacterial plasmid DNA is a bottleneck

Traditional plasmid DNA was designed for research, then scaled into therapeutic manufacturing without redesigning the molecule.

Three places that legacy costs modern programs real time, money, and regulatory friction.

  1. Fermentation Baggage

    • Bacterial fermentation limits throughput per suite
    • Downstream purification is long and expensive
    • Endotoxin and host cell impurities require dedicated removal
    • Scale-up = more tanks, not more molecule per tank

  2. Molecular Baggage

    • Antibiotic-resistance genes carried through into final product
    • CpG motifs trigger innate immune signaling in vivo
    • Large backbone reduces cellular uptake and expression
    • Silencing over time in stable and in vivo settings

  3. Supply Fragility

    • Long lead times force early commitment to a single sequence
    • Any late design change resets the fermentation clock
    • Cell & gene therapy demand growth outpaces supply
    • Single-source risk on a critical raw material

What Makes the Molecule Different

Three advantages
of PIXIE™ mcDNA

PIXIE™ is Celltheon’s proprietary cell-free enzymatic platform for supercoiled minicircle DNA. Every product characteristic below is a direct consequence of skipping bacterial fermentation.

  1. Pillar 1

    Cell-free by construction

    • Zero bacterial fermentation — no HCP, no endotoxin, no host DNA
    • Antibiotic-resistance backbone is customer-optional
    • Low CpG content → reduced innate immunity in vivo
    • Defined enzymatic process; predictable QC profile
  2. Pillar 2

    Supercoiled → therapeutic-grade topology

    • Native supercoiled minicircle topology
    • 2–5× higher expression vs. plasmid DNA
    • Compact expression cassette (backbone stripped)
    • Persistent expression in non-dividing cells
  3. Pillar 3

    Enzymatic → linear scale-up

    • Same molecule from 1 g through kg per lot
    • Scale is added in parallel suites, not larger tanks
    • No re-optimization between clinical and commercial
    • Sequence-locked, GMP-compatible mcDNA

PIXIE™ mcDNA vs. traditional plasmid

A dimension-by-dimension look at how PIXIE™ mcDNA differs from bacterially fermented plasmid DNA — from the molecule to the manufacturing footprint.
Dimension Traditional plasmid PIXIE™ mcDNA
Backbone Bacterial origin + selection marker Backbone-optional; expression cassette only
Antibiotic marker Carried through Removed by design; customer choice
Topology Mixed sc / oc / linear Native supercoiled minicircle
Transfection Baseline 2–5× higher expression
Endotoxin Requires dedicated removal Cell-free → no endotoxin
CpG immunogenicity Elevated — bacterial CpG Low CpG by construction
Manufacturing Bacterial fermentation Enzymatic; parallel suites

Scale ladder —
microgram to gram

PIXIE™ scales linearly by adding parallel enzymatic production suites — not by moving to bigger tanks. The same molecule, at the same QC profile, from research bridge to commercial supply.

  • Mini

    1–10 µg
    Turnaround
    1 week
    Common use
    Sequence verification, low-throughput screens, sanity checks

  • Midi

    10–100 µg
    Turnaround
    1 week
    Common use
    Small-format transfection panels, HTP screening plates

  • Maxi

    0.1–1 mg
    Turnaround
    1 week
    Common use
    Standard transient expression at 50 mL–500 mL scale

  • Mega

    1–10 mg
    Turnaround
    2 weeks
    Common use
    Large scale transient expression for animal studies

  • Giga

    10–100 mg
    Turnaround
    3 weeks
    Common use
    Large scale transient expression for NHP studies

Four Assay Families

The biologic assays we build and run

Every family below covers assay development, qualification, and routine sample runs. Reporter-gene, primary-cell, and effector-cell readouts as fit the molecule.

  1. 01 Largest Application

    Cell & Gene Therapy

    AAV / lentivirus vector production; CAR-T cell engineering; ex vivo gene editing.

    → Higher packaging efficiency, lower host protein burden

  2. 02 IVT Template

    mRNA Vaccines & Therapeutics

    DNA template for in vitro transcription of therapeutic and prophylactic mRNA.

    → Cleaner IVT input, tighter run-to-run consistency

  3. 03 Payload

    DNA Vaccines

    Directly administered plasmid replacement encoding antigens for in vivo immune response.

    → Lower innate immunogenicity, longer episomal persistence

  4. 04 Transient Protein Expression

    Transient Protein Expression

    DNA supply for small to large scale transient protein expression.

    → Backbone-optional for higher titer or ease of downstream transformation

Three Ways to Buy PIXIE™ mcDNA

Engagement models

GLP-scale mcDNA supply is available today, with two adjacent models. GMP-grade supply becomes available in Q1 2027.

  • GLP mcDNA Supply — Primary

    Research- and GLP-grade supply

    Sequence-locked mcDNA at your program’s scale and cadence.

    • Preclinical and IND-enabling supply
    • Backbone-optional per program
    • GLP-grade documentation available
    • Recurring release cadence to plan

    Ideal for: sponsors moving into preclinical or IND-enabling work

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  • PIXIE™ + OmniCHO™ or OmniCFPS™

    Straight to protein

    PIXIE™ mcDNA fed directly into transient CHO or cell-free protein expression.

    • One vendor, gene to expressed protein
    • OmniCHO™ for mammalian transient
    • OmniCFPS™ for cell-free synthesis
    • 1–2 week TAT for recombinant protein expression

    Ideal for: programs needing rapid protein for screening or PD

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  • Available Q1 2027
    GMP mcDNA Supply

    Clinical- and commercial-grade supply

    GMP-grade PIXIE™ mcDNA for clinical and commercial programs.

    • Clinical and commercial supply cadence
    • Regulatory-ready documentation package
    • Same molecule as GLP — no re-cloning
    • Backbone-optional per program

    Ideal for: programs advancing into clinical manufacturing

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Frequently asked questions

Quick answers
to common questions

Quick answers about timelines, quality, and how to work with Celltheon.

Celltheon builds biotech technology platforms and delivers end-to-end solutions that bridge early drug development and manufacturing.

We support biotech and biopharma teams from discovery through preclinical development and manufacturing readiness.

Our offering spans DNA, protein production, engineering, developability, assays, stable cell lines, conjugation, and process development.

Both. Programs can use an integrated workflow or select the individual services and technologies they need.

Yes. Choose platform transfer to your team or a service model executed by Celltheon scientists.

We begin with your goals, molecule, timeline, and deliverables, then provide a clear technical plan and project scope.

We share relevant case studies, quality documentation, platform data, and a project-specific package aligned with your requirements.

Discuss your molecule with our scientists

We don’t workaround — we innovate
and deliver

Explore whether PIXIE™ mcDNA is the right DNA platform for your program.

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