Oligonucleotide and Nucleic Acid Standards

Oligonucleotide and Nucleic Acid Standards

High purity oligonucleotide and nucleic acid formulations

High purity oligonucleotide and nucleic acid formulations

Analytical approaches for testing and characterizing gene-based therapies are always evolving. As larger and more complex nucleic acids are subjected to chromatographic analysis, it becomes increasingly important to have quick access to high quality reference materials for method qualification and system suitability.

Waters now offers the ability to choose the reference material that most closely matches your molecule. Our analytical standards are comprised of individual and pre-mixed oligonucleotide and nucleic acid material that provide coverage for a wide range of molecular weights and chemistries. These standards can help you quickly evaluate method suitability, column health, detector sensitivity and site proficiency for SEC, IPRP, HILIC, and AEX analyses. Manufacturing quality standards is in our DNA.

Oligonucleotide and Nucleic Acid Standards

On-Demand Webinar

Learn about anion-exchange chromatography (AEX) and size-exchange chromatography (SEC) of nucleic acids from Waters experts in our latest webinar: New Insights on Anion Exchange and Size Exclusion of Nucleic Acids.

Learn about anion-exchange chromatography (AEX) and size-exchange chromatography (SEC) of nucleic acids from Waters experts in our latest webinar: New Insights on Anion Exchange and Size Exclusion of Nucleic Acids.


This webinar will be in English

Pink DNA helix on a pink and purple gradient background

Specifications

Overview

  • Match your modality with a myriad of purified oligonucleotide and nucleic acid standards
  • Molecules with multiple uses and compatibility with IPRP, SEC, AEX, and HILIC separations
  • Pre-prepared and ready to dilute reference material for quick benchmarking and troubleshooting
  • High quality, batch tested reference material designed for chromatographic separations

Recommended Use: These standards are meant for LC and LC-MS system performance and suitability testing.


Features Header

Features Header


Oligonucleotide Standards
  • MassPrep Oligonucleotide Standard
  • ssDNA 20-mer LC-MS Standard
  • ssDNA 10 to 60 Ladder
  • ssDNA 20 to 100 Ladder
  • Lipid conjugated ASO
  • siRNA LC-MS Standard
  • sgRNA LC-MS Standard
  • dsDNA 50 to 1350 Ladder

Nucleic Acid Standards
  • dsDNA 50 to 1350 Ladder

Oligonucleotide Specific Analogs

Analytical LC-based methods can become powerful tools for characterizing and confirming the quality of gene therapeutics, whether they be synthetic oligonucleotides, mRNA or vectored transgenes. A method has to be developed, qualified, and then checked for system suitability if it is to be appropriately implemented. Having quality reference materials on hand that are chemically similar to your analytes can make a world of difference.

Our diverse catalog of reference standards includes small interfering RNA (siRNA), lipid-conjugated antisense oligonucleotide (C16-ASO), ssDNA 20-mer, ssDNA length ladders and single guide RNA (sgRNA). These application-specific standards provide ready-to-inject references for method development, intact and MS/MS fragmentation, and system suitability testing.


Climbing the Chromatographic Ladder

Bracket your separation with 15 to 35-mer, 20 to 60-mer and 20 to 100-mer ssDNA ladders for IPRP, HILIC, and AEX analysis. Check the performance of your assays for purity, size variants, failure sequences (N/N-1) nucleotide modifications, and backbone variants. Confirm your pumps are delivering precise gradients, check the selectivity of your adsorption chromatography column, and calibrate the size-based resolving power of your separation.


Unlock SEC, AEX, and RP for Large Nucleic Acids

Nucleic acid therapeutics aren’t getting any shorter. As LC methods improve for even larger nucleic acid species, there also comes a need for new proficiency and system suitability standards. The dsDNA 50 to 1350 bp ladder is certified with wide pore SEC chromatography and can also be readily tested by anion exchange (AEX) and non-denaturing reversed-phase chromatography. The 17 double stranded DNA (dsDNA) components can be used as a reference point for size calibration, system suitability, and method troubleshooting.


Check your Extraction Efficiency

To successfully discern the Drug Metabolism and Pharmacokinetic (DMPK) properties of antisense oligonucleotides (ASO), an analyst must establish robust and efficient extraction procedures. ASO conjugation with lipid moieties enhances targeted delivery into various tissues, but this functionality has proven inherently difficult to recover from biological matrices due to solubility challenges and extreme levels of protein binding. The Waters lipid conjugated ASO LC-MS standard is conjugated with a C16 5’ moiety, and it includes 2’-MOE modifications and a phosphorothioate backbone. It is a highly discriminating reference material and can be used to evaluate the recovery of synthetic therapeutic oligonucleotides to better ensure the development of quantitative sample preparation procedures, such as the protocols provided with OligoWorks SPE.


Confirm Non-Denaturing Analyses of Duplex siRNA

Analysis of siRNA in both denaturing and non-denaturing conditions allows for full characterization of product related impurities. Both IP-RP and HILIC methods can be easily applied with both denaturing and non-denaturing conditions to help support purity and identity measurements of small interfering RNA (siRNA). Above of ~40-50 °C, most siRNA duplexes will begin dissociating into their individual sense and anti-sense single strand constituents. With an appropriately developed, non-denaturing LC assay, it becomes possible to probe duplex formation and quantify the presence of excess non-hybridized single stranded RNA (ssRNA) impurities. The Waters siRNA LC-MS Standard can be readily used to develop and qualify these assays.

Resources

Documents

Documents


Support

Support

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