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Nucleyn Biotech
Nucleyn Biotech

Nucleyn Biotech · Surat, India

Making mRNA medicines easier to check, and easier to keep.

mRNA can be designed in days. Confirming that each batch is intact, and keeping it intact on the way to patients, is still slow and expensive. We’re building practical tools for both, starting on the production floor.

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The problems

Two bottlenecks

01 · Quality testing

Checking a batch of mRNA still needs a central lab.

Every mRNA product has to be confirmed intact. Today that usually means sending samples to a lab with expensive instruments and trained specialists, then waiting. Regulators are asking for more of this checking, not less: the European Medicines Agency’s 2025 draft guideline on mRNA vaccine quality treats RNA integrity as a critical quality attribute.

Our answer

RNACheck

In development

A rapid, low-cost check for mRNA integrity, run where the mRNA is made.

How RNACheck fits into manufacturing

02 · Storage and distribution

mRNA medicines depend on the cold chain.

Most mRNA products must stay refrigerated or frozen from factory to clinic. That adds cost at every step and limits where these medicines can go, especially in hot climates and places with unreliable power.

Our answer

Stabilization platform

Research stage

Long-term research toward mRNA that stays stable at room temperature.

About this research

Progress

Where we are

  1. Done

    Problem and market research, including the 2025 EMA draft guidance

  2. Done

    Design work

  3. Now

    Prototype development

  4. Next

    Laboratory feasibility study

  5. Next

    Pilot partners in mRNA manufacturing

Why Nucleyn

A focused bet on a growing requirement

Regulatory pull.

Regulators are moving to treat RNA integrity as a critical quality attribute, so demand for integrity testing is set to grow with every new mRNA product.

Built for the floor, not the lab.

Designed from the start around the in-process checks that central labs handle slowly.

Fabless by design.

We own the design and the method; established manufacturers make what we design. This keeps us capital-light.

Room to grow.

Every new mRNA product, and every new manufacturing site, needs routine quality checks.

Built for

The teams who make mRNA

mRNA manufacturers.

Faster in-process checks between production steps.

CDMOs.

A routine check that scales across many client programmes.

Research and process development teams.

Quick answers without waiting on the core facility.

Genomics services

Available now

We also analyse RNA sequencing data for research teams through Phylomic: differential expression, pathway analysis and clear reports written for PIs.

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Insights

Latest from Insights

All insights

3 min read

The hidden cost of the mRNA cold chain

The first mRNA vaccines had to be kept frozen, one of them far colder than an ordinary freezer can go. Here is what that means for cost, for logistics and for who can be reached.

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