Waters Enhances Gene-based Therapeutics Development with Innovative GTxResolve Premier SEC Columns

Waters Corporation (NYSE:WAT) has unveiled its latest innovation, the GTxResolve Premier Size Exclusion Chromatography (SEC) 1000Å 3-micron (3 µm) Columns. These columns integrate novel packing materials and MaxPeak™ Premier High-Performance Surface (HPS) technology, designed to expedite the development of gene-based therapeutics such as cell & gene, mRNA, and LNPs. With the burgeoning pipeline of nucleic acid therapeutics growing at a double-digit pace, developers are racing to submit new investigational drug filings and conduct their first in-human trials.

Erin Chambers, Vice President of Consumables and Lab Automation at Waters Corporation, highlights the significance of these SEC columns in meeting the surging demand for mRNA, lipid nanoparticle, and viral vector-based therapies. The columns offer enhanced robustness and efficiency, facilitating standardization of measurements crucial for biological license applications, accelerated approvals, and effective release testing strategies.

Traditional SEC technologies face challenges such as extensive column conditioning, high sample consumption, and lengthy run times. However, Waters’ GTxResolve Premier SEC 1000Å 3 µm Columns address these issues by providing higher sensitivity, resolution, and throughput. By combining novel particle technology with low adsorption MaxPeak Premier HPS Technology, these columns enable quicker assessment of drug safety and efficacy, thereby expediting the development of gene-based therapeutics and vaccines.

Adam Crowe, Analytical Development Manager at Precision Nanosystems, underscores the complexity of RNA lipid nanoparticles and the promise of SEC analyses facilitated by these new column technologies. These analyses offer separations of LNP populations coupled with online or offline detection, providing insights crucial for the development of potent and stable LNP therapeutics.

Engineered to minimize non-specific binding and method development challenges, GTxResolve Premier SEC Columns offer higher throughput separation efficiency and up to 50% increases in resolution for components present within mRNA, LNPs, and viral vector samples. They also boast low out-of-the-box secondary interactions, enabling robust multi-attribute platform methods and over 2x improvements in sample consumption, run times, and sensitivity compared to existing HPLC columns.

Waters GTxResolve Premier SEC 1000Å 3 µm Columns are now globally available, complementing Waters’ previously released GTxResolve Premier BEH SEC 450Å 2.5 µm Columns. These column technologies undergo quality control batch-testing using both protein and nucleic acid test mixtures to ensure new levels of separation reproducibility.

For additional information, visit www.waters.com/GTxResolveSEC, register for the on-demand global webinar, or attend the presentation at the 27th Annual ASGCT Meeting in Baltimore, MD, at the Exhibit Hall Theater on May 8th at 4:30 PM. Connect with Waters via LinkedIn, Twitter, and Facebook for further updates and insights.

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