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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.
- Identity Immunoassays and Sensitive Total Protein Detection
- Capsid Protein Ratio and Titer Quantification
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.
Fast, Sensitive, & Reliable AAV Capsid Titration
Introducing the Simple Plex AAV assay. We have partnered with industry leader PROGEN to automate the AAV 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 AAV assay? Download this application note to see how the PROGEN-ProteinSimple partnership exceeds your expectations with the new Simple Plex AAV assay.
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.
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.
- icIEF Analysis of AAV Proteins for Gene Therapy
- Characterization of AAV Vector Proteins Using Maurice CE-SDS
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.
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.
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.
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.
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.
Which system 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 |
| Runtime | <3 hrs, <5 hrs with RePlex™ | 90 mins |
5 – 35 mins with CE-SDS, 10 – 15 mins with icIEF |
Which systems address vector 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 |
