Gene-Based Therapeutics (GTx) Columns
Confirm physicochemical properties and resolve impurities
Gene therapies have advanced over the past decade, becoming a promising class of therapeutics capable of treating many intractable diseases. On the path to creating and releasing these medicines, uncertainty can arise around drug design, physicochemical properties, delivery system characteristics, impurities, and their correlation to potency and safety.
Chromatography columns with higher recovery, sharper resolution, and improved efficiency help reduce this analytical uncertainty. Waters Gene-Based Therapeutics (GTx) Columns provide an extensive portfolio of chemistries to support the diverse modalities analyzed in today’s gene therapy labs, including reversed-phase liquid chromatography (RPLC), anion exchange (AEX), hydrophilic interaction chromatography (HILIC), and size-exclusion chromatography (SEC). These solutions enable robust LC analysis of a wide range of short nucleic acids (e.g., siRNA, ASOs, etc.), large nucleic acids (e.g., sgRNA, mRNA, dsDNA, plasmid DNA, etc.), and delivery systems including AAVs and LNPs across multiple separation techniques. Having the right column on hand for your unique application can make all the difference.
Gene-Based Therapeutics (GTx) Columns
On-Demand Webinar: GTxResolve RP230A Columns Launch Webinar with Acuitas Therapeutics
In this webinar, we explore the properties and unique selectivity of our new lipid stationary phases, along with best practices and optimization strategies for LNP composition and impurity analysis, critical for vaccines and emerging in vivo CAR-T. Learn how different detectors can enhance insight, how mobile phase additives can be used to tune selectivity, and how unique stationary phase properties enable robust, efficient method development, from discovery through quality testing.
Specifications
Overview
- Take robust physicochemical characterization and quantitative measurements with chromatographic methods
- Choose the ideal retentivity and selectivity with Waters' range of RPLC, AEX, HILIC, and SEC columns
- Select an appropriate oligonucleotide or nucleic acid standard to facilitate system suitability and proficiency testing
Recommended Use: For answering questions about the potency and safety of your gene therapeutics using the accurate, high-throughput data.
Features Header
GTxResolve Premier Column Characteristics
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Batch-tested for consistent performance. -
Bioinert MaxPeak Premier hardware for improved recovery and peak shape.
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Rapid conditioning with ultra-low MALS noise.
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Sub-3 µm BEH particles with low secondary interactions.
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Multiple pore sizes for analyte sizing across broad molecular ranges.
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250 Å Slalom columns enable fast, high-resolution DNA/plasmid separations.
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Batch-tested for lot-to-lot consistency.
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BEH Hybrid Particle Technology for pH and temperature stability.
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Scalable from microflow to preparative purification.
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Bioinert MaxPeak Premier hardware improves recovery and resolution.
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High-resolution separation of oligonucleotide impurities.
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Batch-tested with nucleic acid standards.
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BEH Hybrid Particle Technology for robust stability.
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High-resolution separations with <2 µm amide particles.
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Bioinert MaxPeak Premier hardware for optimal performance.
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MS-compatible, ion-pair-free workflows.
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Formats from ultra-short analytical to microflow columns.
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Batch-tested with lipid standards.
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Superficially porous particles for faster, efficient separations.
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Enhanced retention and resolution of charged lipids.
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Tunable selectivity with phenyl-hexyl+ and C18+ chemistries.
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Bioinert MaxPeak Premier hardware improves recovery and peak shape.
Lipid reversed-phase chromatography for LNP composition and impurity analysis
As lipid nanoparticles (LNPs) continue to be a reliable delivery mechanism for cutting-edge payloads, like in-vivo CAR-T, the need for more advanced lipid analysis is becoming essential. The ability to optimally separate, quantitate, and identify closely related LNP components and impurities is key to ensuring safety, efficacy, and consistency. Lipid-optimized reversed-phase LC plays an important role by enabling detailed characterization of various lipid classes that ultimately influence delivery performance, stability, and overall therapeutic outcomes.
GTxResolve Lipid Reversed Phase Columns deliver unique selectivity and tuned hydrophobicity tailored for lipid analysis. Built on superficially porous particles with wide 230 Å porosity and a positively charged surface, these columns improve peak shape, resolution, and reproducibility for challenging lipid species. Optimized C18+ and Phenyl‑Hexyl+ chemistries support robust, scalable workflows from early development through QC and CMC testing.
Size exclusion and slalom chromatography for purity, biophysical characterization, and stability-indicating assays
SEC enables rapid stability-indicating assays for product integrity and aggregation/fragmentation monitoring. It also supports vector fill analysis, LNP profiling, impurity characterization, and multiattribute quantitation when coupled with multi-angle light scattering (MALS). The GTxResolve Column family delivers low MALS noise and fast equilibration, enabled by robust BEH Particle Technology.
The GTxResolve Premier BEH SEC 450 Å, 2.5 µm Column provides low adsorption and high-efficiency separations for analytes from 100–500 Å, making it ideal for AAV analysis and sgRNA/mRNA separation for LNP payload quantitation. For larger biomolecules, GTxResolve Premier SEC 1000 Å and 2000 Å Columns extend the sizing range using BEH Crosslinked Particles and bioinert MaxPeak Premier Technology hardware to minimize secondary interactions while maintaining separation efficiency. The 1000 Å column (200–800 Å diameter sizing range) supports mRNA integrity, small LNPs (<80 nm), AAV aggregates, and virus like particles (VLPs). The 2000 Å column (800–2500 Å diameter sizing range) is suited for larger LNPs, plasmids, and lentiviral vectors. Both columns can also be combined to enable polysaccharide vaccine characterization.
For large nucleic acids, GTxResolve Slalom Columns offer a unique separation mode for double-stranded DNA (2.5–25 kbp) and plasmids, delivering high resolution, sensitivity, and ultrafast analysis (<5 minutes). Slalom columns support applications such as mRNA IVT monitoring, plasmid linearization efficiency, restriction enzyme mapping, and topology profiling.
Explore Widepore SEC Columns and GTxResolve Slalom Columns
Ion-pairing reversed phase for integrity and purity analysis and purification
Advanced analytical methods involving ion-pairing reversed-phase liquid chromatography can help ensure the identity, purity, integrity, and intended modifications of oligonucleotide and nucleic acid therapeutics.
ACQUITY and XBridge Premier Oligonucleotide BEH C18 Columns are constructed with high-performance surfaces and oligonucleotide batch tested sorbent to ensure reliable separations and a painless turnaround of critical results.
To support workflows from discovery through QC and purification, Waters offers a broad portfolio of ion-pairing reversed-phase columns for oligonucleotide analysis, including microflow LC-MS columns for enhanced sensitivity, analytical scale columns for routine characterization and impurity profiling, and preparative OBD column formats for scalable purification. Together, these platforms provide flexible selectivity, format, and throughput options to support the evolving demands of oligonucleotide and nucleic acid therapeutic development.
Explore enhanced sensitivity with GTxResolve Microflow Columns
Achieve improved N-1 resolution with Oligonucleotide RPLC Columns
Attain higher yield with Oligonucleotide Purification Columns
HILIC Chromatography for Gene Therapeutics
HILIC can retain synthetic oligonucleotides, single guide RNA (sgRNA), messenger RNA (mRNA digests), and viral capsid proteins without needing ion pairing reagents in the mobile phase. Assay your purity, size variants, failure sequences, nucleotide modifications, and backbone variants in a MS-friendly buffer. GTxResolve Premier Amide columns are double batch tested with protein and oligonucleotide controls to ensure optimal chromatographic performance for cell and gene therapy separations.
Explore GTxResolve Premier HILIC Columns
Anion exchange for viral vectors, oligonucleotides, and nucleic acids
Anion exchange is a powerful technique for viral vectors, oligonucleotides, and nucleic acids as they are all anionic.
Protein-Pak Hi Res Q and Gen-Pak FAX Columns provide two unique chemistries for performing assays that can check vector fill, measure titer, and check topology/integrity. Protein-Pak Hi Res Q contains a 5 µm quaternary amine (SAX) resin and the Gen-Pak FAX Column contains a lower retentivity WAX 2.5 µm DEAE sorbent.
Explore Analytical AEX Columns
Oligonucleotide and Nucleic Acid Standards
A selection of different chromatography standards are available, including individual oligonucleotides, sets of different single standard DNA (ssDNA) ladders, a lipid conjugated antisense oligonucleotide, and larger double stranded DNA ladder.
Explore Standards
Preparative scale RPLC for chemically synthesized oligonucleotides
Preparative HPLC is regularly performed to purify chemically synthesized oligonucleotides.
Waters Optimal Bed Density (OBD) 10 to 50 mm ID Columns packed with oligonucleotide tested ethylene bridged hybrid (BEH) C18 particles offer high-efficiency, long-lived setups for such a critical process.
What customers are saying…
“GTxResolve Lipid RP Columns have demonstrated strong performance for lipid quantitation and impurity analysis, with reduced run times and excellent peak shape. The ability to tune separations for specific lipid components, combined with compatibility across multiple detector platforms (UV, MS, ELSD, and CAD), provides significant flexibility for characterization of diverse lipid species. In particular, we have observed a separation of ionizable lipids that has not previously been achieved.”
Adam Kowalczyk, Research Scientist, Analytical Development, Acuitas Therapeutics
