Novel RNA-based therapeutics, including mRNAs, antisense oligonucleotides (ASOs), si/miRNAs, and their complexes in lipid nanoparticles (LNPs) carry an inherent risk of unpredictable innate immune activation, a key driver of reactogenicity and a common cause of costly attrition in late-stage development. RNAte is Australia's first NATA-accredited laboratory specialising in RNA product testing, playing a valuable role in assessing innate immune activation and cytokine signalling in response to these therapeutic candidates.
RNAte supports the entire development pipeline, from early development, preclinical scale-up to clinical evaluation. Through robust innate immune profiling, the platform enables rapid optimisation of RNA candidates, supports evidence-based decision-making, and reduces development risk before progression to animal studies and human clinical trials.
Core capability: innate immune reactivity and reactogenicity profiling of RNAs, ASOs, LNPs and small molecules, using human macrophage and iPSC-derived cell lines. This is augmented by automated high-throughput screening (HTS) capability and backed by experts and specialists at every step.
Broader services: central lab services, customised clinical trial kits, biobanking, and analytical CRO work, including PBMC isolation, receptor occupancy (RO), TBNK immunophenotyping, and pharmacodynamic (PD) cytokine assays.
Backed by decades of research at the Hudson Institute of Medical Research, RNAte has already supported 15 organisations across Australasia and one in Singapore to understand how the innate immune system responds to their therapeutic candidate, positioning it as the go-to organisation with validated, accredited assays that help researchers and companies progress their products with greater confidence, before proceeding into expensive animal or Phase I/II clinical studies.