GTxResolve SEC Columns
Accelerate early research, development, & release testing of GTx drug substances and products
With size exclusion chromatography (SEC), analysts can quickly assess the aggregate content, integrity, heterogeneity, and purity of gene therapy drug substances. Waters GTxResolve SEC Columns incorporate breakthrough chemistry technologies for the fast analysis of large biological analytes and a number of first-of-their-kind multi-attribute quantitation assays.
Achieve new benchmarks in quality with high resolution, low adsorption, and robust GTxResolve SEC Columns for lipid nanoparticles (LNPs), nucleic acids, and viral vector analyses that:
- Accelerate aggregate and size variant analysis with high resolution that enables detection of low-level impurities
- Deliver reproducible data necessary for platform methods
- Improve cost savings with columns that maintain a long shelf life
- Achieve low secondary interaction enabling low MALS noise
- Provide low adsorption hardware necessary with biologics to enhance recovery
GTxResolve SEC Columns
Specifications
Overview
- Support different drug development stages with cost-effective, reproducible, and robust SEC platform methods
- Obtain higher resolution essential for size variant analysis and the detection of low-level impurities
- Achieve sufficient recovery with low adsorption hardware and inert packing materials that reduce the need for large volume sample injections
- Gain valuable multi-attribute measurements on size-distribution, molar mass, aggregate conformations, and absolute titer when combined with universally applied detectors such as multi-angle light scattering detectors (MALS)
- Achieve lower secondary interactions to support the development of platform methods with novel packing material and surface chemistry
Recommended Use: For analyzing aggregate/size variants of gene therapy drug substances and products.
GTx Column Characteristics
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200-800 Å diameter analytes -
3 µm bridge ethylene crossed linked OH-PEO particles
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MaxPeak HPS hardware
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100-500 Å diameter analytes
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2.5 µm Diol bounded BEH particles
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MaxPeak HPS hardware
Drug stability and integrity study for mRNA-LNP based vaccines
Scientists must monitor a drug’s integrity and stability due to the implications on safety and efficacy. Reproducibility, purity, specificity, and linear range are some of the critical quality attributes considered for mRNA-based vaccines. Size exclusion chromatography is a well-suited technique for characterization of larger mRNA and LNP aggregates in nucleic-acid-based vaccines. The consistency of lipid nanoparticle (LNP) content and linear response of two LNP formulations (X1 & X2) from two different manufacturers using GTxResolve Premier SEC 1000 Å was investigated. In the example applications, the linear response is measured by plotting the peak area against the amount of LNP injected onto the GTxResolve Premier SEC 1000 Column.
Integrity analysis for larger nucleic acids
Ion pairing reversed phase chromatography is a commonly applied technique to analyze shorter oligonucleotides in the range of 15–25 mer lengths. Integrity studies involving large nucleic acids, such as dsDNA or mRNA, can benefit from a quick size exclusion analysis. SEC with a GTxResolve Premier SEC 1000 Column makes it possible to achieve high efficiency separations and quickly assess the integrity and stability of larger nucleic acids. In this application, the GTxResolve Premier SEC 1000 Column achieves separation of 50 to 1350 dsDNA molecules, which demonstrates the reproducibility of the column and packing materials.
Platform multi-attribute quantitation with SEC-MALS
Adeno-associated virus (AAV) and other viral vectors are promising modalities for treatment of rare diseases. To ensure the safety and efficacy of these drugs, the drug content as well as the level of impurities needs to be measured. Size exclusion chromatography is a promising separation technique for assessment of the amount of the sample’s different components.
This application demonstrates assessment of degradation pathways for an Adeno-associated virus (AAV) using a novel and robust surface chemistry particle. The lower secondary interactions and high efficiency of the GTXResolve SEC 1000 Å column, facilitates, and elucidates new drug design insights, and can therefore be used as a suitable tool as starting point for platform methods.
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