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PEXT™
Two platforms

Platform 02 · Recombinant Precision · Sequence-defined

Molecular definition, without a single human cell.

This platform is being developed for applications where molecular definition, production consistency, scalability and a human-cell-free process are the primary priorities. Using recombinant DNA technology, a defined human fibronectin gene sequence is introduced into a controlled microbial expression system.
Input
Decoded FN1 sequence
Host
Microbial expression
Human cells
None, at any stage
Output
Recombinant fibronectin

Native biologics and recombinant manufacturing are not competitors. Native biologics provide complex biological communication; recombinant manufacturing provides a more defined molecular product. The two answer different questions.

What a recombinant platform offers is greater molecular definition and scalability. What it cannot do is reproduce the full complexity of a native cellular secretome, and this platform does not claim to.

The honest trade

You gain definition and reproducibility. You give up the coordinated, multi-molecular signalling of a native secretome.

If the application depends on that coordination, Platform 01 is the right choice.

Production route

From a decoded sequence to a purified protein

Every stage is defined in advance. Nothing is left to biological chance.
  1. 01

    Genetic decoding

    The human fibronectin (FN1) gene sequence is decoded and prepared for transfer. Nothing downstream depends on donor tissue.

  2. 02

    Host transformation

    The defined sequence is introduced into a controlled microbial expression host on a purpose-built plasmid.

  3. 03

    Precision fermentation

    Under controlled fermentation, the host synthesizes high-molecular-weight fibronectin matching the human sequence.

  4. 04

    Ultra-purification

    The protein is extracted and purified, yielding a cell-free active ingredient standardized to a defined concentration in every batch.

  5. 05

    Formulation

    The purified recombinant protein is formulated to specification for the intended presentation.

The same route as a single plate, from human gene sequence to finished vial.Fig. 01

What the route buys you

Six properties that follow from a defined sequence

Sequence-defined
The product is specified at the level of the gene sequence, so identity is a design parameter rather than an analytical inference.
No donor variability
There is no donor, so there is no donor-to-donor variation to characterize, control or explain.
Human-cell-free
No human cells or donor tissues are used at any stage of production.
Scalable
Microbial expression scales on fermentation capacity, not on the availability of source tissue.
Regulatory flexibility
Some jurisdictions restrict human-tissue-derived material. A non-human-derived route can be the only viable path in those markets.
Batch reproducibility
A defined process on a defined sequence is the strongest available basis for lot-to-lot consistency.

Where this sits, legally

Product classification is determined by intended use, claims, composition, route of administration, presentation and the requirements of each jurisdiction. A human-cell-free production route changes the material, not the classification, which is still decided case by case.

Regulatory position

The other path

When biological complexity is the point

Platform 01 · Native Biologics