Southern RNA
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Accelerating Early-Phase RNA Development

At Southern RNA, we provide integrated contract development and manufacturing services designed specifically for RNA therapeutics and vaccine programmes. As an Australian-based mRNA CDMO, we partner with biotechnology companies, research institutes and clinical developers to translate innovation into high-quality, regulatory-ready material.

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OVERVIEW

Client & Project Overview

A confidential biotech partner engaged Southern RNA to support the development of a novel mRNA therapeutic. The project encompassed research and development, GMP-aligned manufacturing, and analytical support, with the goal of advancing the programme from early discovery to first-in-human (FIH) clinical studies.

THE CHALLENGE

Scientific & Operational Challenge

The client faced a tight timeline to progress their mRNA candidate into FIH trials. They required high-quality, scalable RNA production while maintaining reproducibility, regulatory alignment, and comprehensive analytical verification. Fragmented workflows and limited in-house capacity created a risk of delays and inconsistencies, which could impact clinical readiness.

OUR APPROACH

Our Approach & Solution

Southern RNA provided a fully integrated solution, combining construct optimisation, process development, GMP-aligned RNA production, and robust analytical testing. Our platform-based workflow minimised handovers, ensured consistent quality, and maintained traceable, audit-ready documentation. Close collaboration with the client allowed us to align deliverables with programme milestones and regulatory requirements.

THE RESULTS

Outcomes & Impact

  • Successfully delivered scalable GMP-aligned RNA for early-phase clinical trials
  • Provided complete analytical and QC documentation suitable for regulatory submission
  • Programme milestones were achieved ahead of schedule, reducing overall project risk
  • High batch-to-batch reproducibility and product quality enhanced confidence in material supply