Gene-Based Therapeutics (GTx) Columns

Gene-Based Therapeutics (GTx) Columns

Confirm physicochemical properties and resolve impurities

Confirm physicochemical properties and resolve impurities

Gene therapies have advanced over the past decade to become a promising class of therapeutics capable of treating many different intractable diseases. On the path to creating and releasing these medicines, there can be uncertainty around drug design, physicochemical properties, impurities, and their correlation to potency and safety.

Chromatography columns with improved recoveries, higher resolution, and greater efficiency make it possible to resolve some of this uncertainty. Waters Gene Therapeutics (GTx) Columns offer the range of columns you need for the many different modalities your lab needs to analyze – a range that includes reversed-phase liquid chromatography (RPLC), anion exchange (AEX), hydrophilic interaction chromatography (HILIC), and size-exclusion chromatography (SEC). Having the right column on hand can make all the difference.

GTxResolve Premier BEH SEC 450 Å 2.5 µm columns enable fast and accurate AAV aggregate analyses and integrity separations for small to medium size mRNA. Gene-Based Therapeutics (GTx) Columns

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

Features Header






Size exclusion chromatography for potency and purity indicating assays

Advances in SEC make it possible to quickly perform potency indicating assays that check aggregation, measure vector fill percentages, and facilitate in-depth characterization of impurities. SEC can also be applied to mRNA, polyA tails, CRISPR RNPs, and sgRNA analyses.

GTxResolve Premier BEH SEC 450Å 2.5 µm Columns offer a low adsorption, high-efficiency SEC column technology to facilitate these assays and the use of advanced detectors for multi-attribute measurements. These columns are well suited to the analysis of AAV gene therapies.

The success of mRNA-based medicine has depended upon the use of efficient delivery vehicles, such as lipid nanoparticles (LNPs) that serve as protective carriers. In addition to their use for medium to large mRNA, GTxResolve Premier SEC 1000Å 3 µm Columns allow analysts to gain valuable insights on some types of LNPs, such as Comirnaty™ vaccines. Moreover, GTxResolve Premier SEC 1000Å 3 µm Columns can help viral vector developers elucidate the degradation pathways that lead to highly aggregated samples. The uses of widepore SEC columns are many!

Explore Widepore SEC Columns


Ion-pairing reversed phase for integrity and purity analysis

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.

Meanwhile, ACQUITY Premier Oligonucleotide BEH C18 2.1 x 20 mm Columns provide new options for achieving ultrafast chromatography. These columns have been carefully optimized for both efficiency and mechanical durability, offering improved throughput for purity, identity, and critical quality attribute testing.

Explore Oligonucleotide RPLC 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.

Explore Analytical AEX Columns

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 Semi-Prep 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.

Explore Oligonucleotide RPLC Prep Columns


Stay compliant with smart column options

Ideal for compliant laboratories, smart column options are available for identifying and tracking column information. The eCord is a data recording device which is permanently attached to the column body of 2.x µm particle size (2.1 and 3.0 mm internal diameter) and ACQUITY UPLC columns and is standard for those column offerings. Rather, the eConnect column tag is a permanently attached electronic tag device for HPLC columns (≥ 2.x µm particles) used with Alliance iS and Alliance iS Bio HPLC Systems that are optional. Data from column devices (eCord device or eConnect column tag) can be accessed using the respective system’s console. These smart-column abilities provide a quick overview of column history and can be utilized as a basic troubleshooting tool. Data residing on these devices are automatically imported by and later searchable via Empower CDS.

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Related

Develop high resolution, ion-pairing free methods for synthetic oligonucleotides, digested nucleic acids and capsid proteins with GTxResolve Premier BEH Amide Columns.

Deliver exceptional sample resolution and superior column lifetime with Waters Oligonucleotide columns for DNA/RNA oligonucleotide separations. Each column is QC-tested to ensure batch-to-batch performance.

Optimize oligonucleotide applications on UPLC or HPLC with prepackaged synthetic oligonucleotide standards, eliminating the need to prepare complex mixtures.

Reliable and robust critical quality attribute analysis of aggregates for Lipids nanoparticles (LNPs), nucleic acids, and viral vectors using GTxResolve columns.

Offers and Discounts

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GTx Columns: An Essential Introduction

Chromatography columns find broad applications in scientific and medical contexts, encompassing tasks like the examination and refining of biological molecules such as DNA, RNA, proteins, and diverse compounds.

Ideal Retentivity and Selectivity with Waters' Columns: Waters is a reputable provider of chromatography columns, offering a diverse range of options, including Reverse Phase Liquid Chromatography (RPLC), Anion Exchange Chromatography (AEX), and Size-Exclusion Chromatography (SEC) columns. These columns come with various properties that can be tailored to specific analytical needs. RPLC, for instance, is excellent for separating hydrophobic compounds, while AEX is used for separating molecules based on charge, and SEC is ideal for size-based separations. Choosing the right column type ensures that scientists can precisely target the physicochemical properties they need to analyze in gene therapeutics.

Recommended Use for Gene Therapeutics: The statement emphasizes the strong endorsement of employing chromatographic methods, especially in conjunction with Waters' columns, for the evaluation of gene therapeutics. In the swiftly progressing domain of Gene therapy, there exists a pressing requirement for precise and efficient data acquisition. Utilizing suitable chromatographic techniques and columns enables researchers to tackle pivotal inquiries related to the effectiveness and safety of gene therapy products. This encompasses tasks such as verifying the integrity of gene vectors, identifying impurities or aggregations, and conducting a comprehensive assessment of the therapeutic substance's overall quality. The generation of dependable, high-quality data stands as an indispensable element that serves the dual purpose of advancing gene therapy research and securing the necessary regulatory approvals in this cutting-edge field. Hence, the strategic application of chromatographic methods with specialized columns is of paramount importance in ensuring the efficacy and safety of gene therapy initiatives.

Final Thoughts and Insights

Waters Gene Therapeutics (GTx) Columns present a versatile and comprehensive solution for laboratories involved in the analysis of various gene therapy modalities. These columns offer a diverse range of chromatographic techniques, including Reversed-Phase Liquid Chromatography (RPLC), Anion Exchange (AEX), and Size-Exclusion Chromatography (SEC), addressing the multifaceted demands of gene therapy research. This versatility is critical because gene therapy encompasses a wide range of molecules, from gene vectors to proteins and nucleic acids, necessitating various analytical approaches. RPLC aids in assessing hydrophobic components, AEX specializes in charge-based separations, and SEC is crucial for characterizing macromolecules like viral vectors. This comprehensive suite of column modalities enables researchers to ensure the safety, potency, and overall quality of gene therapy products by tailoring their analyses to specific molecular properties, thereby enhancing the precision and efficiency of their research endeavors.