News Summary:

• New line of GTxResolve™ Premier SEC Columns provide higher sensitivity, resolution, and throughput to accelerate the development of cell & gene-based therapeutics.
• Reduces problematic non-specific binding, minimizes mobile phase method development challenges, and provides higher throughput separation efficiency.
• Increases resolution up to 50% for components present within mRNA, lipid nanoparticles (LNP), and viral vectorsⁱ for more confident measurement of critical quality attributes tied to safety, stability, and potency.

MILFORD, Mass. — Waters Corporation (NYSE:WAT) today introduced new GTxResolve Premier Size Exclusion Chromatography (SEC) 1000Å 3-micron (3 µm) Columns. Waters has implemented a unique combination of novel packing materials and MaxPeak™ Premier High-Performance Surface (HPS) technology into the columns to help scientists accelerate the development of gene-based therapeutics, including cell & gene, mRNA and LNPs.

“The pipeline of nucleic acid therapeutics continues to grow at a double-digit paceⁱⁱ as developers strive to submit new investigational drug filings and complete their first in-human trials. The new Waters GTxResolve Premier SEC Columns supports the growing demand for mRNA, lipid nanoparticle, and viral vector-based therapies with columns that are more robust and provide higher efficiency,” said Erin Chambers, Vice President, Consumables and Lab Automation, Waters Corporation. “These SEC columns help to standardize measurements needed to fulfill biological license applications, achieve accelerated approvals, and establish effective release testing strategies.”

SEC has emerged as an important platform analytical technique, but existing technologies require extensive column conditioning, consume large amounts of sample, and require lengthy run times to resolve impurities, making them an imperfect solution. Waters GTxResolve Premier SEC 1000Å 3 µm Columns address those challenges by providing higher sensitivity, resolution, and throughput by combining novel particle technology with low adsorption MaxPeak Premier HPS Technology. They make it possible for scientists to assess drug safety and efficacy more quickly and expedite the development of gene-based therapeutics and vaccines that are both more efficacious and accessible to patients globally.

“RNA lipid nanoparticles are analytically complex therapeutics. Traditional batch analysis techniques only discern information of the drug product as a whole and fail to detect the subtle difference in particle size populations and corresponding compositional variations therein,” said Adam Crowe, Analytical Development Manager, Precision Nanosystems. “SEC analyses afforded by these new column technologies are promising because they have shown separations of LNP populations that can be coupled with online or offline detection. These insights could aid the development of more potent, more stable LNP therapeutics.”

GTxResolve Premier SEC Columns are engineered to reduce problematic non-specific binding, minimize mobile phase method development challenges, and provide higher throughput separation efficiency. They offer up to 50% increases in resolution for components present within mRNA, LNPs, and viral vector samples. They offer low out-of-the-box secondary interactions^{i, iii, iv}, enabling robust multi-attribute platform methods and more than 2x improvements in sample consumption, run times, and sensitivity versus existing 5 and 10 µm HPLC columns.^v

Waters GTxResolve Premier SEC 1000Å 3 µm Columns are now available globally, alongside Waters previously released GTxResolve Premier BEH SEC 450Å 2.5 µm Columns. These column technologies are quality control batch-tested with an industry-first use of both protein and nucleic acid test mixtures to ensure new levels of separation reproducibility.

 Additional Resources

• Learn more at www.waters.com/GTxResolveSEC
• Register for our on-demand global webinar
• Attend our Presentation at the 27^th Annual ASGCT Meeting in Baltimore, MD: Exhibit Hall Theater – May 8^th 4:30 PM
• Follow and connect with Waters via LinkedIn, Twitter, and Facebook

About Waters Corporation (www.waters.com)

Waters Corporation (NYSE:WAT), a global leader in analytical instruments and software, has pioneered chromatography, mass spectrometry, and thermal analysis innovations serving the life, materials, food, and environmental sciences for more than 65 years. With approximately 7,900 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, and with products available in more than 100 countries.

Waters, GTxResolve, and MaxPeak are trademarks of Waters Technologies Corporation.