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Nucleyn Biotech

Product · mRNA manufacturing QC

RNACheck

In development

Rapid RNA integrity QC for mRNA manufacturing. RNA integrity is a critical quality attribute, and RNACheck is being developed to give manufacturing teams a faster, more practical way to assess it during production.

The gap

Routine checks shouldn’t wait in a lab queue

Release testing in a central lab will always matter. But the routine checks between production steps don’t need to wait days for a lab queue. RNACheck is designed to make those in-process checks fast and local.

The people who need the answer are on the production floor: process engineers deciding whether to move a batch forward, and QC teams who want problems caught early rather than at release. Today they send samples away and wait, and the batch waits with them.

Design goals

What we are designing for

These are goals for the product in development, not measured results.

Minutes, not days
Results at the point of manufacture.
Focused on integrity
Is the mRNA complete and intact.
Low cost per test
Affordable enough for routine use.
Minimal training
Usable by production staff, not only specialists.
Traceable
Every result recorded for traceability.
Made for every market
Practical where large analytical labs are scarce.

Where it fits

Alongside the central lab, not instead of it

  1. Synthesis

  2. Purification

  3. Formulation

  4. Fill

  5. Release testing

    CENTRAL LAB batch release

In-process checks span synthesis, purification, formulation and fill. This is where RNACheck is designed to fit.

A generic mRNA production flow. Release testing stays with the central lab.

Status

In development

RNACheck is in development. Design work is complete and prototype development is the current milestone.

Making mRNA? Let’s talk.

We’re looking for a small number of manufacturing and process development teams to shape RNACheck with us as pilot partners.

Become a pilot partner