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.
"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 interactionsi,
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 27th Annual ASGCT
Meeting in Baltimore, MD: Exhibit
Hall Theater - May 8th
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
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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
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iii "Size
Exclusion and Ion Exchange Chromatographic Hardware Modified with a
Hydrophilic Hybrid Surface." Anal. Chem. 2022, 94, 7,
3360–3367.
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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.
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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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