Viral Vector Solutions

Viral Vector Solutions

Comprehensively characterize viral vectors and perform potency and safety indicating measurements using Waters sensitive, high-resolution analytical tools and techniques. Waters combines chromatography columns and systems, optical and mass analysis detectors, and automated compliance-ready data analysis and reporting tools for turnkey application success.

Comprehensively characterize viral vectors and perform potency and safety indicating measurements using Waters sensitive, high-resolution analytical tools and techniques. Waters combines chromatography columns and systems, optical and mass analysis detectors, and automated compliance-ready data analysis and reporting tools for turnkey application success.
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Characterize LNPs to ensure product safety and efficacy.
Characterize LNPs to ensure product safety and efficacy.

Overview

Viral vector-based gene therapies are large drug product formulations comprised of protein and nucleic acid components containing over 200,000 atoms. Waters liquid chromatography (LC) combined with optical detection (UV, MALS) and mass spectrometry (MS) provide the analytical means to accurately characterize and quantify these heterogeneous structures and their attributes, at both component and intact levels. Routine measurements include viral titer, aggregate/impurities analysis, viral protein ratios, peptide mapping & modification analysis, encapsidation efficiency, and genome integrity.

Applications

Waters provides precision engineered SEC, HILIC, and IEX columns tailored for AAV and adenovirus applications, and robust HPLC/UHPLC/UPLC systems that can highly resolve viral vector components. Larger capsids especially susceptible to shear are separated more gently using field-flow fractionation (FFF).

Waters provides precision engineered SEC, HILIC, and IEX columns tailored for AAV and adenovirus applications, and robust HPLC/UHPLC/UPLC systems that can highly resolve viral vector components. Larger capsids especially susceptible to shear are separated more gently using field-flow fractionation (FFF).

Application Notes

AAV capsids are made of three viral proteins that self-assemble in a 1:1:10 ratio. Post-translational modifications (PTMs) can impact product performance. Workflows for PTM & impurities analysis support capsid engineering, process development and release testing.

AAV capsids are made of three viral proteins that self-assemble in a 1:1:10 ratio. Post-translational modifications (PTMs) can impact product performance. Workflows for PTM & impurities analysis support capsid engineering, process development and release testing.

Application Notes

Size exclusion chromatography with multiangle light scattering (SEC-MALS) and UV detection enables measurement of multiple AAV attributes, including titer, size-distribution, molar mass, aggregate, and empty/full ratio. Asymmetric field flow fractionation with MALS (FFF-MALS) allows for measurement of larger capsids.

Size exclusion chromatography with multiangle light scattering (SEC-MALS) and UV detection enables measurement of multiple AAV attributes, including titer, size-distribution, molar mass, aggregate, and empty/full ratio. Asymmetric field flow fractionation with MALS (FFF-MALS) allows for measurement of larger capsids.

Application Notes

Genome integrity testing ensures the viral vector genome contains only the intended genetic sequence and is free from mutations or rearrangements. Alkaline gel electrophoresis has historically been used but lacks resolution. Higher-resolution LC methods are highly desired for accurate measurement.

Genome integrity testing ensures the viral vector genome contains only the intended genetic sequence and is free from mutations or rearrangements. Alkaline gel electrophoresis has historically been used but lacks resolution. Higher-resolution LC methods are highly desired for accurate measurement.

Application Notes

ultraDAWN real-time MALS directly monitors product attributes post-purification, enhancing yield and flexibility. It connects downstream purification and enrichment methods, such as IEX, FPLC, or TFF, to measure capsid, genomic titer, size, and impurities in real-time, streamlining processing and maximizing yield.

ultraDAWN real-time MALS directly monitors product attributes post-purification, enhancing yield and flexibility. It connects downstream purification and enrichment methods, such as IEX, FPLC, or TFF, to measure capsid, genomic titer, size, and impurities in real-time, streamlining processing and maximizing yield.

Application Notes

Webinar: Small Particle Low Adsorption SEC Columns for Fast and Efficient Characterization of AAV via SEC-MALS

A look at SEC-MALS through the eyes of veteran chromatographer, Dr. Bala Addepalli, who discusses column selection and optimization of chromatographic methods prior to MALS detection to achieve maximum resolution and reproducibility when separating proteins, nucleic acids and intact viral vectors.

A look at SEC-MALS through the eyes of veteran chromatographer, Dr. Bala Addepalli, who discusses column selection and optimization of chromatographic methods prior to MALS detection to achieve maximum resolution and reproducibility when separating proteins, nucleic acids and intact viral vectors.
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Solutions

Waters LC and LC-MS systems offer leading separations performance and sensitivity for viral vector analysis.

Waters LC and LC-MS systems offer leading separations performance and sensitivity for viral vector 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 biological molecules.

  • Enhanced Separations
  • Capsid Engineering & PTM Analysis
  • Titer, Aggregates, and Intact Heterogeneity
  • Genome Integrity

For efficient product attribute monitoring throughout development

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

Enable LC-MS biopharmaceutical analyses in every GxP lab with Waters BioAccord LC-MS System including high-resolution MS and waters_connect software for compliance-ready data analysis and reporting.

  • Enhanced Separations
  • Capsid Engineering & PTM Analysis

Complete high-resolution coverage for confident characterization

Complete high-resolution coverage for confident characterization
Xevo G3 QTof

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

  • Enhanced Separations
  • Capsid Engineering & PTM Analysis

QC-friendly multi-attribute monitoring

QC-friendly multi-attribute monitoring
DAWN & ultraDAWN MALS Detectors

Accurately measure viral vector aggregation, genome and capsid titer, and empty/full ratio with Wyatt’s DAWN & ultraDAWN MALS detectors with UV & RI detection post LC or FFF separation.

  • Enhanced Separations
  • Genome Encapsidation Measurements
  • Titer, Aggregates, and Intact Heterogeneity

Compliance-ready, networkable applications-based software to streamline LC-MS data acquisition, processing, and reporting.

Compliance-ready, networkable applications-based software to streamline LC-MS data acquisition, processing, and reporting.

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.

  • Sequence and Modification Confirmation
  • Impurity Analysis
  • Quantitative Analysis

Simplify data acquisition, processing, and reporting

Simplify data acquisition, processing, and reporting
Empower Chromatography Data System (CDS)

Equip your lab with Empower Chromatography Data System (CDS) and gain advanced laboratory data management for your viral vector analyses, including acquisition, processing, and reporting.

  • Cell Culture Monitoring

Columns for size exclusion, ion exchange and reversed phase chromatography.

Columns for size exclusion, ion exchange and reversed phase chromatography.

Widepore SEC columns for viral vector separations

Widepore SEC columns for viral vector separations
GTxResolve Premier SEC Columns

Enable measurement of multiple attributes, including aggregation & size variant analysis with Waters high efficiency GTxResolve Premier SEC columns that speed analysis time and lower sample consumption.

  • Enhanced Separations
  • Titer, Aggregates, and Intact Heterogeneity
  • Genome Integrity

Anion exchange (AEX) for measuring encapsidation efficiency

Anion exchange (AEX) for measuring encapsidation efficiency
AEX Columns for Gene-based Therapeutics (GTx)

Improve recovery with Waters AEX chromatography that uses a non-porous, high efficiency stationary phase (e.g.:Protein-Pak Hi Res Q) combined with optimized salt gradients for a QC-friendly technique for empty/full measurements.

  • Enhanced Separations
  • Titer, Aggregates, and Intact Heterogeneity
  • Genome Integrity

RPLC Columns for viral protein analyses

RPLC Columns for viral protein analyses
MaxPeak Premier BEH C4 RPLC Columns

Identify and measure the relative abundance of viral proteins using MaxPeak Premier BEH C4 columns with DFA ion pairing for optimal LC and MS performance. 

  • Enhanced Separations
  • Titer, Aggregates, and Intact Heterogeneity

RPLC columns for viral vector peptide mapping

RPLC columns for viral vector peptide mapping
MaxPeak Premier CSH C18 RPLC Columns

Confirm the sequence, post translational modification (PTMs), or degradation of viral proteins using peptide mapping and Waters CSH™ columns that deliver high resolution for this application.

  • Enhanced Separations
  • Capsid Engineering & PTM Analysis

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 to maintain peak system performance, minimize down time, address application challenges, and support stringent compliance requirements.

  • Enhanced Separations
  • Capsid Engineering & PTM Analysis
  • Titer, Aggregates, and Intact Heterogeneity
  • Genome Integrity

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.

  • Enhanced Separations
  • Capsid Engineering & PTM Analysis
  • Titer, Aggregates, and Intact Heterogeneity
  • Genome Integrity

The data speaks for itself

The data speaks for itself
a) Overlayed mass spectrum of AAV8 zoomed into to the 2.5–6 MDa mass range with 100 % empty, and full capsid treated with 30-minute incubations at 4, 22, 35, and 50 °C. b) Charge spectrum of AAV8 zoomed into the 2.5–6 MDa mass range with 100 % empty, and full capsid treated with 30-minute incubations at 4, 22, 35 and 50 °C.
Full (blue) and empty (red) titers determined by RT-MALS during elution (34 – 48 minutes) and strip (> 48 minutes) in the final linear gradient. Buffer ionic strength is represented by the dashed black line.
Zoomed views of an AAV2 chromatogram as obtained with stainless- steel hardware (4.6 x 150 mm, 5 µm particle, red trace) versus hHPS hardware (XBridge Premier GTx BEH SEC 450 Å 2.5 µm 4.6 x 150 mm Column, black trace). Separations were performed with a mobile phase containing a standard ionic strength buffer (10 mM phosphate pH 7.4 + 200 mM KCl).
Relative quantification of VP proteins was measured by optical detection, including (A) UV and (B) Fluorescence (FLR). Peak annotation shows the assignment and calculated relative abundance of the detected components. With FLR detection, the S/N of VP3 is almost five times higher than the S/N of using UV detection with a 10-fold higher mass load, suggesting an approximately 50-fold improvement in sensitivity.

Webinars and Resources

  • eBook

Characterizing AAVs

Characterizing AAVs
Download
  • Poster

Stability Characterization of Multiple Serotypes of Adeno-Associated Virus Using Charge Detection Mass Spectrometry

Stability Characterization of Multiple Serotypes of Adeno-Associated Virus Using Charge Detection Mass Spectrometry
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  • On Demand Webinar

Fast but Sure AAV Aggregate Analysis with Platform Size Exclusion Methods

Fast but Sure AAV Aggregate Analysis with Platform Size Exclusion Methods
Download

Related

Nucleic Acid Solutions
Waters offers a complete portfolio of liquid chromatography systems, instruments, mass spectrometers, and analytical solutions for nucleic acid research of long-chain varieties (mRNA, ssDNA, dsDNA).

Lipid Nanoparticle Solutions
Accurately analyze intact particles and molecular compositions with purposefully designed lipid nanoparticle (LNP) analysis solutions from Waters to generate high-quality, reliable lab data.

Learn more about Viral Vector Solutions.

Learn more about Viral Vector Solutions.
Characterize LNPs to ensure product safety and efficacy.
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