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The success of the COVID-19 mRNA vaccines has demonstrated the potential of RNA vaccines and therapies. Over the next decade, RNA is poised to become a central drug platform for treating a wide range of human diseases.

Accessible services include RNA design, plasmid amplification and linearisation, RNA manufacture (1-5mg), and the necessary analytics to ensure a high-quality product. RNA manufacture is supported by appropriate quality systems that enable best-practise standards, ensuring documented and robust, scalable processes.

Current production capabilities include:

• pDNA (sub mg to +10 mg)
• mRNA (up to ~100mg)
• Small RNAs (eg. siRNA, 5 to 500 mg)
• Oligo RNA/DNA (up to 100 nt)

To function in vivo, RNAs requires a safe, effective and stable delivery system to protect the nucleic acid from degradation, for targeted delivery, and allow uptake into cells and subsequent release. Lipid nanoparticles are the most currently successful platform and have been used for COVID-19 vaccines. TIA facilities can offer expertise and experience in the development and formulation of lipid nanoparticles (LNPs) that enable the clinical delivery of RNA molecules.

TIA supports a suite of GMP facilities that manufacture high quality biologics, vaccines, RNA, viral vector and cell therapies. These facilities will work with you to develop manufacturing processes suitable for Phase I clinical trials and beyond. With in-depth understanding of regulatory requirements (TGA, FDA, ISO9001, FACT), the facilities can advise on best practice and provide documentation to support regulatory processes.

Developing novel therapeutic products is risky, expensive and takes a long time. TIA facilities can help you understand the many steps involved in developing your product, reducing risk and improving the pathway to commercialisation.

Having lived experience of navigating regulatory pathways, and working with industry partners, TIA facility staff are a great resource to help you understand the necessary steps towards starting a clinical trial and making complex regulatory submissions.

A fit-for-purpose quality system is crucial to ensure reliability and reproducibility of results, and is a prerequisite for accreditation under many internationally-recognised codes of practice. When setting up a quality system for the first time, TIA has brought together a suite of documents, named iQDOCs, with generic examples of documents relevant for each of the common standards, from ISO9001 to FACT and TGA-licenced GMP. Our facilities work within phase-appropriate quality frameworks relevant for their needs and these documents can also assist in establishing, maintaining or build your quality system.