Reliable capsid titer measurement is one of the most critical analytical requirements in AAV gene therapy development. However, moving a titer assay from development to a GMP-regulated quality control (QC) environment presents several challenges. This webinar will explore the validation of an analytical method for quantifying AAV9 capsid titer using a commercially available titer kit and the adaptation of an automated immunoassay for GMP use.
The method was developed and validated in accordance with ICH Q2 and Q14 guidelines. The featured speakers will examine the validation strategy, covering specificity, precision, accuracy, working range, system suitability and how each performance characteristic was assessed. The validation results support the assay’s robustness and suitability for GMP applications, providing a practical example of how reliable titer data can inform process decisions and product quality assessments.
Beyond validation, the webinar will place this work in the broader context of an integrated CDMO approach for AAV-based gene therapies. Attendees will learn how scalable platform technologies, GMP manufacturing capabilities and comprehensive QC methods support AAV programs throughout the development lifecycle.
A recurring theme is the choice of analytical technology. Automated immunoassays offer advantages such as low sample consumption, rapid turnaround times and support for regulatory compliance. These capabilities are particularly valuable when working with complex, limited gene therapy materials. The speakers will share practical insights into achieving reliable and reproducible capsid titer analysis across development stages.
Drawing on experience validating an AAV9 capsid titer assay for GMP use, this session will provide practical guidance for establishing AAV analytics, preparing methods for validation and improving viral vector QC workflows.
Register for this webinar to learn how AAV gene therapy titer assay validation can support GMP readiness, strengthen analytical reliability and improve QC workflows.
Who Should Attend
This webinar will appeal to professionals involved in AAV gene therapy development, analytical method validation and GMP manufacturing, including:
Quality Control and Quality Assurance Scientists and Managers
Analytical Development/Method Scientists
Bioprocess and CMC leads
Biotech and pharma teams
Regulatory Affairs professionals
Viral Vector Manufacturing Scientists
Gene Therapy Development Scientists
What You Will Learn
Attendees will gain insight into:
Validating AAV9 capsid titer assays according to ICH Q2 and Q14 for GMP-regulated QC applications
Assessing specificity, precision, accuracy, working range and system suitability to demonstrate assay robustness
How automation, low sample consumption and fast turnaround support reliable analysis of complex gene therapy products
Integrating platform technologies, GMP manufacturing and QC analytics for AAV programs
Register free on Xtalks:
https://xtalks.com/webinars/reduce-aav-gene-therapy-gmp-risks-with-regulatory-ready-titer-assays/
