Synthetic Oligonucleotide Analysis

Synthetic Oligonucleotide Analysis

From sample preparation to chromatographic separation, optical and mass detection, and compliance-ready data analysis and reporting, Waters fit-for-purpose tools for oligonucleotide analysis deliver leading-edge performance and productivity and are backed by our global service and support teams to accelerate your therapeutic, diagnostic and research development efforts.

From sample preparation to chromatographic separation, optical and mass detection, and compliance-ready data analysis and reporting, Waters fit-for-purpose tools for oligonucleotide analysis deliver leading-edge performance and productivity and are backed by our global service and support teams to accelerate your therapeutic, diagnostic and research development efforts.
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Overview

A resurgence in the development of oligonucleotide therapeutics has led to burgeoning pipelines across the industry. Working at the level of gene transcription and translation, these short nucleic acid drugs hold great promise for many inherited disorders and common ailments alike.

Waters LC-MS tools and techniques play a critically important role in confirming the identity and purity of these drugs, as well as quantifying their presence in biofluids.

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Applications

With oligonucleotide therapeutics, the sequence and location of modified nucleotides are of critical importance to their function, stability, and efficacy. LC-MS/MS fragmentation is a key technique that can provide this level of sequence confirmation, and automated data analysis and reporting tools make the process fast and easy.

With oligonucleotide therapeutics, the sequence and location of modified nucleotides are of critical importance to their function, stability, and efficacy. LC-MS/MS fragmentation is a key technique that can provide this level of sequence confirmation, and automated data analysis and reporting tools make the process fast and easy.

Application Notes

Application Notes

Synthetic oligonucleotides contain many process and product related impurities, including truncated n-X failure sequences, oxidized (e.g.: PS to PO conversions) and deaminated variants, and for dsRNA species (e.g.: siRNA) single stranded components are considered impurities. For regulatory filings these impurities must be identified and well characterized.

Synthetic oligonucleotides contain many process and product related impurities, including truncated n-X failure sequences, oxidized (e.g.: PS to PO conversions) and deaminated variants, and for dsRNA species (e.g.: siRNA) single stranded components are considered impurities. For regulatory filings these impurities must be identified and well characterized.

Application Notes

Application Notes

Quantitative analysis of oligonucleotides from biofluids requires effective, sample preparation approaches to achieve maximum recovery, reproducibility, and lower limits of detection. Waters sample preparation, liquid chromatography, and mass spectrometry tools are designed to deliver the sensitivity, repeatability, and productivity needed for your oligonucleotide bioanalysis projects.

Quantitative analysis of oligonucleotides from biofluids requires effective, sample preparation approaches to achieve maximum recovery, reproducibility, and lower limits of detection. Waters sample preparation, liquid chromatography, and mass spectrometry tools are designed to deliver the sensitivity, repeatability, and productivity needed for your oligonucleotide bioanalysis projects.

Application Notes

Application Notes

Case Study: BioSpring Implements Waters LC-MS Workflows for Oligonucleotides to Expand Existing Portfolio

Learn how BioSpring leveraged compliance-ready Waters BioAccord LC-MS System and Vion IMS QTof with waters_connect to ensure data integrity, support shorter turnaround times, and meet regulatory requirements as it expanded its oligonucleotide manufacturing and analysis services.

Learn how BioSpring leveraged compliance-ready Waters BioAccord LC-MS System and Vion IMS QTof with waters_connect to ensure data integrity, support shorter turnaround times, and meet regulatory requirements as it expanded its oligonucleotide manufacturing and analysis services.
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Solutions

Waters LC and LC-MS systems offer leading separations performance and sensitivity for synthetic oligonucleotide analysis.

Waters LC and LC-MS systems offer leading separations performance and sensitivity for synthetic oligonucleotide analysis.

Ultra-low adsorption for maximum sensitivity and reproducibility

Ultra-low adsorption for maximum sensitivity and reproducibility
MaxPeak Premier Solutions

MaxPeak Premier columns and systems eliminate the unpredictability of analyte losses due to metal interactions, which can be especially pronounced with negatively charged oligonucleotides.

  • Characterization
  • Impurities Analysis
  • Quantitative Analysis

For efficient product attribute monitoring throughout development

For efficient product attribute monitoring throughout development
BioAccord LC-MS System with ACQUITY Premier

Simplify high-performance LC-MS biopharmaceutical analysis for every user with Waters BioAccord LC-MS System with ACQUITY Premier, an integrated, compliance-ready platform that can be deployed from discovery to GxP labs.

  • Characterization
  • Impurities Analysis
  • Quantitative Analysis

Complete high-resolution coverage for confident characterization

Complete high-resolution coverage for confident characterization
Xevo G3 QTof

Accelerate characterization of synthetic oligonucleotides with the Xevo G3 QTof high-performance HRMS benchtop system that delivers accurate qualitative and quantitative results.

  • Characterization
  • Impurities Analysis
  • Quantitative Analysis

Exquisite sensitivity for quantification analyses

Exquisite sensitivity for quantification analyses
Xevo TQ Absolute Triple Quadrupole Mass Spectrometry

Expand the scope of ultimate sensitivity analysis with Waters Xevo TQ Absolute Triple Quadrupole Mass Spectrometry that delivers unprecedented levels of reliability, reproducibility, and performance for your oligonucleotide applications.

  • Quantitative Analysis

Waters software streamlines data acquisition, processing, and reporting oligonucleotide analysis results.

Waters software streamlines data acquisition, processing, and reporting oligonucleotide analysis results.

Streamline data analysis and processing

Streamline data analysis and processing
waters_connect for biopharmaceuticals

Accelerate the journey from sample analysis to decision-making with waters_connect for biopharmaceutical analysis with apps for intact mass analysis, sequence confirmation, process monitoring, and more.

  • Quantitative Analysis
  • Impurities Analysis
  • Sequence and Modification Confirmation

Oligonucleotide columns, standards and sample prep tools purposely designed to deliver maximum performance and productivity.

Oligonucleotide columns, standards and sample prep tools purposely designed to deliver maximum performance and productivity.

Enhanced sensitivity with unmatched pH and temperature stability

Enhanced sensitivity with unmatched pH and temperature stability
MaxPeak Premier BEH C18 Columns for Oligonucleotide Analysis

MaxPeak Premier Oligonucleotide BEH C18 reversed phase columns offer high pH and temperature tolerance, exceptional resolution, and ultra-low adsorption for enhanced sensitivity and reproducibility. Analyte-specific QC testing on every sorbent batch ensures lot-to-lot performance.

  • Impurities Analysis
  • Quantitative Analysis
  • Characterization

High recovery extraction kits for LC-MS quantitation

High recovery extraction kits for LC-MS quantitation
OligoWorks SPE Kits & Components

Achieve up to 2X increased recovery, a streamlined workflow, and enhanced LC-MS sensitivity and repeatability with OligoWorks SPE Kits and Components for the extraction of oligonucleotide therapeutics and metabolites from biofluids.

  • Quantitative Analysis

Benchmark column and system performance with confidence

Benchmark column and system performance with confidence
Oligonucleotide / Nucleic Acid Standards

Eliminate the need to prepare complex mixtures with Waters prepackaged, lot-certified oligonucleotide standards that deliver ease-of-use and peace-of-mind when running oligonucleotide separations.

  • Quantitative Analysis
  • Impurities Analysis
  • Characterization

Orthogonal selectivity with ion-pairing-free chromatograph

Orthogonal selectivity with ion-pairing-free chromatograph
Gene-Based (GTx) Therapeutics Columns

Anion exchange (AEX) and hydrophilic interaction chromatography (HILIC) provide orthogonal selectivity and ion pairing free LC options. Waters offers both weak and strong AEX columns as well as amide bonded BEH HILIC columns that provide an array of new method options.

  • Quantitative Analysis
  • Impurities Analysis
  • Characterization

Gain efficiency and walk away time with verified lab automation solutions

Gain efficiency and walk away time with verified lab automation solutions

Enhance sample prep efficiency and throughput

Enhance sample prep efficiency and throughput
Laboratory Automation and Equipment

Streamline the extraction of oligonucleotides from biofluids for quantitative LC-MS analyses with verified workflows that help minimize variability, improve traceability, and simplify method transfer.

  • Quantitative Analysis
  • Impurities Analysis
  • Sequence and Modification Confirmation

Your success is just a click away

Your success is just a click away
Waters Global Services

Optimize your laboratory's productivity and success with Waters Global Services. Maintain peak system performance, minimize down time, address application challenges and support stringent compliance requirements.

  • Quantitative Analysis
  • Impurities Analysis
  • Sequence and Modification Confirmation

Make science more accessible with Waters Capital

Make science more accessible with Waters Capital
Payment Solutions

Maximize resources and minimize risk with payment options from Waters Capital, including upgrading aging equipment, getting customized support and bundling services into one monthly payment.

  • Quantitative Analysis
  • Impurities Analysis
  • Sequence and Modification Confirmation

The data speaks for itself

The data speaks for itself
Testing the inertness of the ACQUITY Premier UPLC System and ACQUITY Premier OST Column using the 21-nt oligomer: UV chromatogram of the lowest detectable concentration (0.5 nM, or 5 femtomoles of the 21-mer oligonucleotide loaded on-column) compared against the preceding blank injection.
Calibration curves of GEM91 using a stainless-steel column and conventional system (red), an ACQUITY Premier Column and conventional system (blue), and an ACQUITY Premier Column and System (purple). The different slopes indicate distinct differences in recovery using the columns and systems tested.
TUV and TIC chromatograms showing the performance of the BioAccord System when the 1 μM OST standard was diluted 100 times (100 fmoles sample loading). All five major oligos are clearly detected in both the UV and TIC chromatograms, indicating that the LC-MS system and method has adequate sensitivity for detecting low-level oligo impurities.
LC-MS/MS full ladder sequence confirmation for the ssRNA sequence of 5'-UCGUCAAGCGAUUACAAGGTT-3' was achieved. The experiment was conducted using the M4- peak as the precursor ion. The fragmentation peak assignments were done by matching against the theoretical masses using simple Excel file calculations. MaxEnt3 was used for charge deconvolution and deisotoping.

Webinars and Resources

  • Brochure

Quantifying Oligonucleotides Brochure

Quantifying Oligonucleotides Brochure
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  • eBook

Characterizing Oligonucleotides eBook

Characterizing Oligonucleotides eBook
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  • Brochure

Oligonucleotide Analysis Solutions: Streamlined Decisions for Consistent Quality Flyer

Oligonucleotide Analysis Solutions: Streamlined Decisions for Consistent Quality Flyer
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  • Application Notebook

Oligonucleotides Applications Notebook

Oligonucleotides Applications Notebook
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  • Poster

Adding Cost Effective Mass Detection for Improved Productivity in Oligonucleotide Screening Assays

Adding Cost Effective Mass Detection for Improved Productivity in Oligonucleotide Screening Assays
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Related

Biopharma and Pharma
Waters accessible yet powerful analytical workflow solutions translate complexity into clarity, so you can efficiently access the knowledge to take your product from Point A to Point FDA, EMA, and beyond.

Learn more about Synthetic Oligonucleotide Solutions.

Learn more about Synthetic Oligonucleotide Solutions.
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