Reduce AAV Gene Therapy GMP Risks with Regulatory-Ready Titer Assays
Earn a Certificate of Live Attendance
AI Webinar Explorer available after event
About this webinar
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
- 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
- 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
Featured Speakers
Linda Klauss
Linda Klauss holds a position as Field Application Scientist at Gyros Protein Technologies, based in Uppsala, Sweden. Gyros is a biotechnology company that develops, produces and provides a complete bioanalytical system for protein quantification based on immunoassays. Linda joined the company in 2017 as Field Application Specialist providing application support to the customers in the DACH area. Her experience covers a wide range of ligand binding assays including applications for pharmacokinetics, immunogenicity testing, biomarker monitoring, impurity testing and product quantification for therapeutic protein development, in both regulated and non-regulated environments. Prior to joining Gyros Protein Technologies Linda worked as a research associate in pre-clinical development at several pharmaceutical companies in the Netherlands
Linda holds an MSc in Biochemistry from Leiden University and a PhD from Heidelberg University, with a focus on microbiology and biochemistry.
Matthias Gora
Matthias Gora is a Senior Technician in Analytical Development and QC at Ascend Advanced Therapies, an international CDMO specializing in gene therapy. He has been with the company since 2018 gaining extensive insight in AAV vectors of varying serotypes. He has worked on several analytical projects involving characterization, stability testing and release testing in R&D and QC/GMP environments, including technology transfer, qualification and validation. He completed his training as a Biological-Technical Assistant at the Dr. Erwin Elhardt School of Chemistry (CEM) in Munich. Prior to Ascend, he spent a year in diagnostics at Myriad, working on cancer risk assessment.
Partner for this event
Gyros Protein Technologies
Gyros Protein Technologies provides enabling bioanalytical and peptide synthesis solutions that help scientists increase biomolecule performance and productivity in research, drug discovery, pre-clinical and clinical development, and bioprocess applications. Proprietary high performance nanoliter-scale immunoassay platforms, Gyrolab® xPand, Gyrolab® xP workstation and Gyrolab xPlore™, are used by scientists in leading pharmaceutical, biotech, CRO, and CMO companies for bioanalytical applications such as pharmacokinetics/pharmacodynamics, immunogenicity, and quantitating bioprocess-related impurities. Our low to mid-scale peptide synthesizer platforms and chemistries deliver uncompromising purity, flexibility, and quality for discovery and pre-clinical studies of simple to complex multifunctional peptides. Our peptide synthesis and bioanalytical solutions accelerate your discovery, development, and manufacturing of safer biotherapeutics. Gyros Protein Technologies is part of the Biopharmaceutical Division of Mesa Laboratories, Inc.