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.

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).




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.


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 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

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

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

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


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 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 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) 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 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


  • 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
  • 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

Related

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).

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.