Waters Accelerates the Development of Gene-based Therapeutics with New GTxResolve Premier SEC Columns

Rhea-AI Summary

Waters introduces new GTxResolve Premier SEC Columns to accelerate the development of gene-based therapeutics. The columns offer higher sensitivity, resolution, and throughput, reducing non-specific binding, minimizing method development challenges, and increasing separation efficiency. They provide up to 50% more resolution for components in mRNA, LNP, and viral vectors, aiding in measuring critical quality attributes. The SEC columns support the growing demand for nucleic acid therapeutics and streamline biological license applications and release testing strategies.

Positive

• The new GTxResolve Premier SEC Columns by Waters offer higher sensitivity, resolution, and throughput for the development of gene-based therapeutics.
• Reduces non-specific binding, minimizes method development challenges, and increases separation efficiency, providing up to 50% more resolution for components in mRNA, LNP, and viral vectors.
• The SEC columns support the growing demand for nucleic acid therapeutics and help standardize measurements for biological license applications and release testing strategies.
• Waters GTxResolve Premier SEC Columns address challenges of existing technologies by combining novel particle technology with low adsorption MaxPeak Premier HPS Technology, enabling quicker assessment of drug safety and efficacy.
• Engineered to reduce non-specific binding, minimize method development challenges, and provide higher throughput separation efficiency, the SEC columns offer improvements in sample consumption, run times, and sensitivity.
• The columns are now available globally and are quality control batch-tested for separation reproducibility with an industry-first use of protein and nucleic acid test mixtures.

Negative

• None.

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., April 22, 2024 /PRNewswire/ -- 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.

Waters GTxResolve Premier SEC Columns support the growing demand for mRNA, LNP, and viral-vector-based therapies.

"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.

Contact:

Janice Foley
Senior Public Relations Manager, Corporate Communications
Waters Corporation
janice_foley@waters.com
+1.617.823.5555

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i For 1000Å 3 µm GTxResolve Premier SEC columns versus conventional steel 5 and 10 µm columns
ii +11% for Phase I cell & gene therapy programs according to American Society of Gene + Cell Therapy, "Gene, Cell, + RNA Therapy Landscape Report", Q1 2024
iii "Size Exclusion and Ion Exchange Chromatographic Hardware Modified with a Hydrophilic Hybrid Surface." Anal. Chem. 2022, 94, 7, 3360–3367.
iv "Investigating the secondary interactions of packing materials for size-exclusion chromatography of therapeutic proteins." Journal of Chromatography A, Volume 1676, 2 August 2022, 463262.
v "Fast and efficient size exclusion chromatography of adeno associated viral vectors with 2.5 micrometer particle low adsorption columns." Journal of Chromatography A, Volume 1714, 11 January 2024, 46458

 

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SOURCE Waters Corporation

FAQ

What is the new product introduced by Waters to accelerate the development of gene-based therapeutics?

Waters introduced new GTxResolve Premier SEC Columns.

What are some key features of the GTxResolve Premier SEC Columns?

The columns offer higher sensitivity, resolution, and throughput, reduce non-specific binding, minimize method development challenges, and provide up to 50% more resolution for components in mRNA, LNP, and viral vectors.

How do the GTxResolve Premier SEC Columns support the development of gene-based therapeutics?

The columns help standardize measurements for biological license applications and release testing strategies, addressing challenges of existing technologies by enabling quicker assessment of drug safety and efficacy.

Where can the GTxResolve Premier SEC Columns be found?

The SEC columns are now available globally.

What kind of testing has been done on the GTxResolve Premier SEC Columns?

The columns are quality control batch-tested for separation reproducibility with an industry-first use of protein and nucleic acid test mixtures.