Transitioning to AAV producer cell lines: navigating comparability, bridging studies, and regulatory risk

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

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Transitioning to AAV producer cell lines: navigating comparability, bridging studies, and regulatory risk

As AAV-based gene therapies continue to advance toward broader indications, manufacturing efficiency, consistency, and scalability are becoming critical enablers of commercial viability. Traditional transient transfection approaches introduce supply chain complexity, batch-to-batch variability, and scaling limitations, prompting increasing interest in stable producer cell line (PCL)–based manufacturing.

Transitioning from transient transfection to a PCL represents a manufacturing process change, not simply a material change, and must be evaluated within the framework of ICH Q5E and applicable global regulatory guidance. Analytical comparability serves as the foundation for assessing potential impacts to product quality, safety, and efficacy, and informs the need for additional nonclinical or clinical bridging studies.

In this fireside chat, industry experts will explore practical considerations for adopting PCL-based processes, including how the timing of the transition influences regulatory expectations and development risk. Panelists will also discuss the role of robust analytical strategies in supporting comparability, as well as the potential of PCL platforms to deliver improved productivity, consistency, and scalability, supporting long-term cost reduction and manufacturing robustness.

Attend this session to:

Understand the distinction between a manufacturing process change and a material change when transitioning to a producer cell line, and how that distinction affects your comparability strategy
Gain a framework for determining when analytical comparability data alone is sufficient versus when nonclinical or clinical bridging may be required
Assess how transition timing affects regulatory risk, development burden, and the path toward scalable, cost-efficient AAV manufacturing
Apply practical considerations for engaging CMC, regulatory, process development, and CDMO partners when planning and executing a platform transition

Vijetha Bhat

Subject Expert, Platform Technologies at Lonza

Vijetha Bhat is a technology expert working within Licensing in Lonza’s Specialized Modalities division. She has over 15 years of experience in the biopharma industry. Vijetha started her scientific career at Lonza in 2017 and has since contributed to a variety of projects focusing on developing production platforms and analytics for viral vectors in the cell and gene therapy space. She currently supports with providing in-depth technical direction to users working with Lonza’s expression platforms.

Vijetha has a background in biotechnology from India. She graduated from Rice University in Houston with a degree in Bioengineering. Prior to joining Lonza, she worked at Nanospectra Biosciences, an early-stage medical device company, developing nanotechnology-based therapies for oncology applications.

Wenling Dong

Head of Upstream Process Development at Lonza

Wenling Dong serves as Head of Process Development Viral Vector at Lonza Specialized Modalities based in Houston. Leveraging over 25 years of experience in research, process development, and GMP manucturing, she leads a high-performing team to develop and tech transfer manufacturing processes for various viral vectors, focusing on product quality, safety, and efficacy. Prior to Lonza, she held roles as a bioprocess engineer at various healthcare companies, including Baxter, GSK, and Teva. Wenling holds a Masters of Science in Chemical and Biochemical Engineering from the University of Maryland Baltimore County, a Masters of Science in Applied Chemistry from Shanghai Jiao Tong University and Bachelor of Science in Chemical Engineering from East China University of Science and Technology.

Laura Sands

Head of Regulatory Affairs at Lonza

In 25 Days

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