Waters Corporation (NYSE: WAT) has announced the launch of a new set of tools designed to simplify and accelerate the analysis of large molecule RNA therapeutics using liquid chromatography-mass spectrometry (LC-MS) technology. The new offering includes sample preparation enzymes, reagents, and the waters_connect software, all aimed at enhancing sequence and modification confirmation of these complex molecules. These tools are expected to play a crucial role in the development of RNA-based pharmaceuticals, such as CRISPR single-guide RNA (sgRNA) and messenger RNA (mRNA) therapies.
Large molecule RNA therapeutics have emerged as a significant advancement in modern pharmaceuticals, with the potential to address life-threatening diseases. They have already contributed to the development of COVID-19 vaccines and hold promise for personalised cancer treatments and genetic therapies for conditions such as sickle cell anaemia. The complexity of RNA molecules, however, presents challenges for ensuring their stability, safety, and effectiveness, requiring precise and efficient methods for their analysis.
Erin Chambers, Vice President of Consumables and Lab Automation at Waters Corporation, highlighted the need for advanced measurement techniques as RNA-based therapies move towards wider application. “More direct composition measurements are needed to ensure stability, safety, and effectiveness for patients,” she explained. “Our new enzymes, reagents, and software simplify the confirmation of sequences and modifications in RNA molecules, allowing researchers to accelerate therapeutic development while reducing barriers for those less experienced with LC-MS.”
The company’s new tools include two novel enzymes, RapiZyme™ MC1 and RapiZyme Cusativin, which simplify RNA digestion and improve sequence coverage. This allows for a more confident analysis of RNA molecules compared to traditional digestion methods. Additionally, Waters has introduced IonHance™ HFIP, a reagent that enhances ionisation, increasing the clarity and accuracy of RNA spectral data during LC-MS analysis.
The tools are complemented by Waters’ MAP Sequence application, part of the waters_connect software platform, which streamlines RNA LC-MS oligo mapping workflows. This new software significantly reduces the time needed for data processing, providing faster and more reliable results than traditional manual methods. Together, these tools generate an LC-MS fingerprint that confirms the identity, purity, and efficacy of RNA products, improving the overall quality of the analysis.
Dr. Arnaud Delobel, R&D and Innovation Director at Quality Assistance S.A. and a beta tester of the new tools, praised the launch, noting the significant benefits for those working on RNA therapies. “Waters’ new enzymes efficiently digest mRNA and sgRNA, delivering reproducible results quickly. The MAP Sequence software allows users to confidently process data in a fraction of the time required by manual techniques,” Dr. Delobel said.
The new RNA analytical tools from Waters Corporation are aimed at accelerating the development of RNA-based treatments, ultimately supporting the transition of these therapies from research to clinical use. RapiZyme RNAses and IonHance HFIP are available now, with the MAP Sequence software set to launch on 18 October 2024.
