AAV: Comprehensive Characterization
Wyatt Technology provides the instruments and methods you need for quantifying multiple critical quality attributes of AAV-based therapies throughout the product life cycle. Our solutions are simple to learn and operate, yet directly access the core biophysical properties that define these CQAs.
The following techniques are rapid, fully automated and require little hands-on effort:
- Size-exclusion chromatography with multi-angle light scattering (SEC-MALS)
- High-throughput dynamic light scattering (HT-DLS) and
- Field-flow fractionation with MALS (FFF-MALS)
To learn how light scattering technologies can enhance your AAV characterization workflow, request the brochure Solutions for AAV Characterization.
SEC-MALS Implementation, Training and SOP
SEC-MALS is a powerful analytical technique that provides many benefits:
- Quantify capsid concentration, Vg/Cp and aggregate content
- Multiple CQAs in a single automated run
- No primers or reagents
- Unmatched accuracy, precision and repeatability
- Appropriate for product development, formulation and process development
- GMP-compliant for quality control and lot release
AAV Method Implementation and Training Service
Wyatt has developed a personalized, on-site, application-specific training to bring customers up to speed in a matter of days. AAV MI&T saves significant time and effort in learning, method development and validation.
SOP Guidance Manual: Critical quality attributes of AAVs by SEC-MALS
This comprehensive document serves as a complete reference and pathway to customizing, qualifying and implementing the SEC-MALS AAV method for your specific needs. Use this manual to prepare it for adoption as a platform method for all AAV development and production.
Please contact us for additional details on our solutions for implementing SEC-MALS characterization of AAVs.
AAV Method Implementation Packages
New to SEC-MALS or building a new facility for AAV development? A sales engineer will help design the optimal AAV characterization system which includes an SEC setup with an optimal SEC column, MALS and dRI detectors, and ASTRA software.
AAV Startup Package
For SEC-MALS beginners as well as experienced SEC-MALS practitioners who are new to SEC-MALS analysis of AAVs, the AAV Startup Package includes the Viral Vector Analysis software module, AAV Method Implementation & Training service and a copy of the AAV SOP Guidance Manual.
AAV Extension Package
This package is appropriate for sites that have already purchased the AAV Startup Package and are adding additional SEC-MALS stations for AAV analysis or need to train new staff. It includes the full on-site training plus an additional Viral Vector Analysis module license.
AAV SOP Guidance Manual and Training
This package is appropriate for SEC-MALS users who already have the Viral Vector Analysis module and need to quickly build up complete AAV characterization capabilities.