Keynote Presentation: Gene Therapy Manufacturing with Live Q&A

Presented By: Keynote Presentation: Gene Therapy Manufacturing with Live Q&A

Speaker Biography: Baley Reeves was appointed interim director of the National Center for Therapeutics Manufacturing (NCTM) in 2023 and currently leads NCTM’s mRNA project initiatives. She has over 15 years of experience in downstream processing and over 11 years of experience in biomanufacturing workforce training, and has expertise in the recovery and purification of recombinant proteins, vaccines, and gene therapy products, as well as experience in cGMP manufacturing and process development. Prior to joining NCTM, Baley was a senior scientist at the Biomanufacturing Training and Education Center (BTEC), where she developed and taught courses for biotech industry leaders, regulatory agencies, and the WHO. She has also worked on numerous vaccine-related projects, including a global survey of the vaccine manufacturing landscape with the Bill and Melinda Gates Foundation. Baley holds a Ph.D. in chemical engineering from Princeton University, where she was a National Science Foundation Graduate Fellow. She has authored articles on protein purification in Trends in Biotechnology, Protein Science, Protein Expression and Purification, and Microbial Cell Factories, as well as articles on biomanufacturing training and education published in Chemical Engineering Education.

Webinar: Keynote Presentation: Gene Therapy Manufacturing with Live Q&A

Webinar Abstract: The field of gene therapy has enabled the treatment and potential cures for serious, monogenetic diseases. This form of advanced therapy relies on the delivery of the “correct” copy of a gene to a patient’s cells, and often utilizes a viral vector to achieve this goal. This presentation will give an overview of the history of gene therapy products as well as insight into the current state of the market and the size of the pipeline. In addition, a broad overview of the cGMP manufacturing process for adeno associated virus (AAV)-based gene therapies will be covered, including unit operations for production, purification, and formulation. Finally, other relevant topics such as targeted drug delivery, navigating the regulatory process, and the price point of gene therapy products will also be covered.

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