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Vector Characterization

Our analytical platforms give you the automation and scalability needed for the development and manufacturing of cell and gene therapy vectors, and low volume requirements help you preserve these precious samples. Platform methods can be seamlessly transferred across labs and project phases—from discovery to manufacturing—giving you consistent vector characterization results from start to finish.

 

Adeno-Associated Virus (AAV)

Don't waste your precious AAV samples! Our automated, high-throughput systems let you characterize AAVs in sample volumes as low as 3 µL with high sensitivity and reproducibility. Get multi-attribute measurements of AAV titer, empty/full content ratio, capsid protein ratio, purity, stability, identity, and more.

Multi-Attribute AAV Characterization

Using only 3 µL of AAV sample, Simple Western on Jess™ and Abby™ can provide a wealth of information from your AAVs samples including CQAs that must be monitored during AAV manufacturing. No sample cleanup is required - Simple Western handles complex sample types like whole-cell lysates. And Simple Western has the automation and throughput you need to scale with AAV manufacturing workflows. 

Quantify Empty/Full Content Ratio

Simple Western method automatically separates AAV samples by Size or Charge followed by specific and sensitive detection using anti-DNA and anti-VP1/2/3 antibodies directly in the capillary for quantitative and reproducible measurement of these central AAV components.

Jess Simple Western AAV characterization including AAV viral titer and capsid ratio and viral identification

Fast, Sensitive, & Reliable AAV2 Capsid Titration

Introducing the Simple Plex AAV2 assay. We have partnered with industry leader PROGEN to automate the AAV2 titration ELISA to provide fast and efficient viral quantitation with superior specificity. Discover how you can accelerate your cell and gene therapy workflows with Ella.

A PROGEN-ProteinSimple Partnership

Curious about the linearity, recovery, and dynamic range of the new Simple Plex AAV2 assay? Download this application note to see how the PROGEN-ProteinSimple partnership exceeds your expectations with the new Simple Plex AAV2 assay.

    AAV2 simple plex cartridge for AAV viral titer assays

    Stability, Identity, and Purity - All on One System

    Safely delivering a gene therapy means ensuring the stability, identity, and purity of your AAV vector. The Maurice system combines imaged capillary isoelectric focusing (icIEF) and CE-SDS analysis, letting you get all of that data with one compact system. Load up to 100 samples in a batch and walk away, Maurice takes care of the rest. Results are ready in 6-25 minutes using sample volumes as low as 50 µL.

    See What's Inside Your AAV Capsids

    Are your AAV capsids empty, full, or just partially full? Maurice with icIEF detection equips you to determine exactly that. Read the application note to find out how to develop a reproducible method for AAV characterization. You’ll also see how this method is stability-indicating, and most importantly, can give you critical information on your capsid’s DNA content by leveraging Maurice’s absorbance and native fluorescence detection modes.

    Exploring the Charge Heterogeneity in Recombinant Adeno-associated Virus with Imaged Isoelectric Focusing

    Identify AAV Aggregates and Contaminants

    Monitoring of aggregates of AAV capsids is important for ensuring stability of the vector, but methods such as light obscuration and microscopy have limitations with their ability to detect translucent aggregates or lack of throughput. Our MFI systems directly image subvisible particles in solution to provide data for 10 different morphological parameters, allowing you to identify AAV aggregates as well as any contaminants or impurities in your sample.

    Monitor the Effect of Ultrafiltration on the Preparation of AAVs

    To measure the effect of ultrafiltration on subvisible particle formation, researchers at Voyager Therapeutics relied on MFI to measure the size and concentration of subvisible particles that formed in solution. This is the first study to provide a quantitative understanding of the ultrafiltration behavior of AAVs for gene therapy to guide process development.

    Protein Aggregation and Particle Analysis

     

    Lentivirus

    All-in-One Titer, Capsid Content, Stability, Purity, & Transduction Assays

    Simple Western provides truly multi-attribute analysis for lentivirus vectors characterization that scales with manufacturing workflows. With a single instrument like Jess, you can quantify titer, stability, capsid content, purity, transduction efficiency and more, even in complex sample types like whole-cell lysate. As an open platform, any target of interest may be analyzed using conventional antibodies. Quantify purity using anti-HCP antibodies or Total Protein Detection with sensitivity that beats SDS-PAGE stains like SYPRO Ruby. Reduce upfront capital expenditure and overall costs, including time and labor, to bring new cell and gene therapies to market.

    3-D illustration of a virus

    Simple Plex Lentivirus Titer and Purity Assays

    Titer: p24 Assay

    The Simple Plex assay for the detection of human HIV-1 Gag p24 combines high throughput with superior accuracy and precision to enable rapid quantification of lentiviral capsid proteins throughout different stages of cell and vector manufacturing. The automated, reproducible nature of the Simple Plex p24 assay helps eliminate user error, making it an ideal tool in good manufacturing practice (GMP) environments where quality, standardization of process, assay transfer, and scalability are highly desirable.

    Purity: HEK 293 HCP 3G Assay

    Ella delivers excellent sensitivity and extended dynamic range to ensure precise sample detectability at each stage of the purification process. The assay is based on the same antibodies currently used in the Cygnus HEK 293 HCP ELISA kit, 3G Resupply 1 (F650S). As a result, you get the same accuracy and consistency you would expect from the Cygnus ELISA, but with an automated, streamlined workflow.

    Simple Plex HEK-HCP Assay

     

    Lipid Nanoparticles (LNP)

    Easily Measure Surface Charge for Formulations

    Characterization of the identity and stability of LNP delivery vectors is key to ensuring the safety and efficacy of your therapeutic. Maurice makes measuring the surface charge of these large, complex particles easy. See how researchers at Merck use Maurice during process and formulation development of an LNP-based mRNA vaccine. 

    Learn how cIEF and CE-SDS on Maurice is used in a manufacturing setting to assess purity and stability of AAVs and identity of LNP in a webinar featuring John Loughney, Director, Vaccine Analytical Research & Development at Merck and Chris Heger, Senior Manager, Applications Science at ProteinSimple.

    exosome

    Which platform is right for me?

    Platform Specifications Simple Western Simple Plex Maurice
    Main Sample Type Virus and tissue lysates, supernatants Virus lysates, supernatants, and purified virus preparation Virus preparation (>70% pure)
    Assay Type CE-SDS/cIEF + immunoassay Sandwich ELISA CE-SDS or icIEF
    Detection Modes Chemiluminescence, Fluorescence, Total protein stain Fluorescence Absorbance & Native Fluorescence
    Sample Volume 3 μL 25 μL 50 μL
    Assay Development Single antibody — open platform None — Fully validated kits No antibody — open platform
    Quantitative Yes Yes Yes
    Size or Charge Separation Yes   Yes
    Dynamic Range 3 to 4 logs 3 to 5 logs 3 logs
    Detection Range (GC or VP/mL) 109 – 1012 106 – 1010 1011 – 1014

    How do these platforms address cell and gene therapy CQAs?

    Critical Quality Attribute Attribute Detail Simple Western Simple Plex Maurice
    Identity Is my virus present in the sample?

    Yes

    Yes Yes
    Identity Am I confident it is the right virus? Yes Yes Yes
    Potency Physical viral titer Yes Yes  
    Potency Functional viral titer Yes    
    Potency Protein Expression Potency Yes Yes  
    Potency Capsid protein ratio (VP ratios) Yes   Yes
    Purity Process-related impurities Yes Yes Yes
    Purity Host cell-related impurities Yes Yes Yes
    Purity Capsid Content (Empty/Full) Yes   Yes
    Stability Aggregate formation     MFI
    Stability Product stability Yes   Yes