Accelerating AAV biosafety and characterization decisions with validated NGS workflows

Tuesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

Sponsor

Accelerating AAV biosafety and characterization decisions with validated NGS workflows

Live30 webinars pack the latest innovations and applications into a data-rich 30-minute session.

Biosafety testing and product characterization for AAV-based gene therapies can take 6–8 weeks using conventional methods. This webinar presents two validated next-generation sequencing (NGS) workflows that reduce that turnaround to approximately 1–2 weeks, with quantified sensitivity, GMP-ready bioinformatics pipelines, and regulator-aligned reporting designed to support IND/BLA submissions and comparability packages.

Attendees will gain a practical understanding of how untargeted short-read sequencing and genome integrity profiling can be implemented within a GMP framework to strengthen CQA definition and reduce late-stage risk.

Attend this webinar to:

Evaluate untargeted short-read NGS workflows for adventitious agent detection across DNA/RNA viruses and microbes, with practical limits of detection of approximately 1 virus per 1,000–10,000 cells
Apply genome integrity analyses to confirm AAV identity and resolve truncations, rearrangements, and ITR structure, including rare variant detection to ~0.006%
Understand how pre-set QC thresholds, validated bioinformatics pipelines, and version-controlled outputs support audit readiness and regulatory submission
Assess the operational impact of outsourcing NGS-based characterization, including faster decision timelines and streamlined comparability data packages

Register now to gain practical, data-backed guidance on integrating NGS into your AAV characterization and release strategy.

Andrew Hillhouse

Principal Scientist Group Lead, Analytical Development at FUJIFILM Biotechnologies

Andrew (Drew) Hillhouse is Principal Scientist and Group Lead for Next Generation Sequencing (NGS) at FUJIFILM Biotechnologies in Biotechnologies’ Texas facility. In this role, Dr. Hillhouse leads NGS assay development efforts for product characterization and biosafety testing. His group has worked to develop viral identification and genome integrity testing as well as adventitious agent testing assays for client programs.

Dr Hillhouse has worked in NGS applications across industry and academia for over 10 years. Prior to joining FUJIFIM Biotechnologies, he was a research assistant professor and faculty member at Texas A&M University, where he led the Texas A&M Institute for Genome Sciences and Society Molecular Genomics Core facility. In this role, he assisted in providing next generation sequencing services to research labs within the Texas A&M University system and their collaborators.

Dr Hillhouse received his PhD from the University of Missouri in Columbia researching genetic factors that contribute to intestinal inflammation susceptibility and then performed postdoctoral research at North Carolina State University investigating how those genetic factors contributed to development of colorectal cancer.

You have registered for this webinar