Waters’ New Bioseparation Tools Enhance and Accelerate RNA-based Vaccine and Therapy Development with LC-MS Analysis

Waters Corporation today unveiled a new suite of sample preparation enzymes, reagents, and the waters_connect software, designed to simplify the sequence and modification confirmation of large-molecule RNA therapeutics using liquid chromatography-mass spectrometry (LC-MS). These bioseparation tools, when integrated into a workflow, accelerate and enhance the development of innovative RNA-based pharmaceuticals, including CRISPR sgRNA and mRNA therapeutics.

RNA-based therapeutics represent a major breakthrough in pharmaceutical innovation, offering promising treatments for diseases such as COVID-19, personalized cancer therapies, and emerging CRISPR RNA therapies for genetic conditions like sickle cell anemia.

“As RNA therapies move towards widespread use, more accurate composition measurements are crucial to ensure patient safety, stability, and efficacy,” said Erin Chambers, Vice President of Consumables and Lab Automation at Waters Corporation. “Waters’ enzymes, reagents, and software are specifically designed to streamline the confirmation of complex RNA molecules, helping accelerate therapeutic development and making LC-MS more accessible to non-experts.”

Arnaud Delobel, PhD, R&D and Innovation Director at Quality Assistance S.A., and a beta tester of Waters’ RNA tools, added, “Waters’ new enzymes efficiently digest mRNA and sgRNA with short incubation times, and data processing in MAP Sequence provides rapid, reproducible results.”

Waters’ RNA analytical tools include:

  • Enzymes: Two novel enzymes, RapiZyme™ MC1 and RapiZyme Cusativin, are part of a simplified three-step protocol that ensures complete LC-MS sequence coverage, surpassing traditional digestion methods for better RNA molecule characterization.
  • Reagents: IonHance™ HFIP, an LC-MS-grade reagent, improves ionization and enhances spectral clarity and detection accuracy for RNA components.
  • Software: The MAP Sequence application, part of the waters_connect software platform, simplifies RNA oligo mapping workflows, speeding up analysis and data processing compared to manual spreadsheet-based methods.

Together, these tools provide an LC-MS fingerprint that confirms product identity, purity, and efficacy, while improving sequence coverage, data quality, and interpretation. Supported by the compliance-ready waters_connect platform, these tools help advance LC and LC-MS-based digestion analysis from research and development to release and at-line process testing.

Waters RapiZyme RNAses and IonHance HFIP are available now. The MAP Sequence App on the waters_connect software platform will be available on October 18, 2024.

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