Webinar Enhancing Downstream AAV Processing Efficiency

Enhancing Downstream AAV Processing Efficiency: Using Data Analytics to Simplify and Speed up Development of Robust Filtration and Chromatographic Unit Operation

AAV vectors are widely used in gene therapy, but their production presents challenges for manufacturers. To address this, we focused on streamlining the downstream processing of AAV particles in our study. This involved two key steps: TFF and capture chromatography. We used MODDE^® DOE software and small-scale screening devices and systems to optimize materials and process parameters for those unit operations.

We tackled TFF optimization, which can be tricky with limited feed material and tight timelines. Multiple flat sheet cassettes were compared, and process parameters for AAV8 concentration and diafiltration TFF were screened through performance of a DOE with the Ambr^® CF.

Lastly, we explored an alternative to affinity-based chromatography using cation exchange principle with the potential to purify various AAV serotypes and capsid configurations. We'll share our journey of developing an AAV8 capture chromatography method based on monoliths by optimizing process parameters through DOE.

What You Will Learn:

Learn how MODDE® helps in defining optimal experiments
Learn about TFF optimization using DOE
Learn about chromatographic method development using DOE

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Presenters

Dr. Franziska Bollmann

Dr. Franziska Bollmann works as a Program Manager for Separation Technologies at Sartorius Stedim Biotech. In this role, she assumes responsibility for managing external partnerships with both industrial and academic entities, focusing on the generation of application data and process knowledge to advance Adeno-associated Virus (AAV) production processes. Before assuming her current position, Dr. Bollmann held various roles, including that of External Collaborations Manager, Process Technology Consultant and Virus Scientist. Throughout these roles, she accumulated extensive experience spanning over seven years in the development of viral vector production processes geared towards gene therapy applications.

Marc Noverraz

Marc Noverraz has been working for Sartorius since 2021, where he is a Process Technology Manager for Separation Technologies. He earned his chemical engineering masters degree at EPFL in Lausanne, Switzerland. Marc held various positions in process development for biopharma manufacturing, in particular the purification of vaccines and viral vectors, and was leading a downstream process development group at Janssen. As of 2021, he has been working as a Process Technology Manager focusing on downstream processing of new modalities where he helps to fit Sartorius' technologies into those new processes such as AAV, lentivirus and mRNA.