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January 10, 2022

A new review article by iBET and Sanofi researchers in Current Opinion in Biotechnology addresses the most pressing challenges around recombinant Adeno-Associated Vector (rAAV) bioprocessing and analytics.

As part of a themed issue on Nanobiotechnology, this review highlights existing bottlenecks in the rAAV manufacturing field and pinpoints solutions under development to better understand rAAV bioprocess development, including cell line development, monitoring tools, and analytics for in-process upstream and downstream processes and for final product characterization.

Patrícia Gomes-Alves from iBET, co-author of the paper, highlights the importance of improving monitoring and analytical tools to overcome emerging concerns around high dosage safety in rAAV-based gene therapy: “It is crucial to develop better analytical tools to define critical quality attributes (CQAs) and improve bioprocess understanding. These will help us to improve Chemistry, Manufacturing and Control (CMC) efforts and product safety, required for the growing demand in rAAVs.”

Click here to read the article and know more about the current key areas of focus to improve quality assessment and safety of rAAV-based gene-therapy products.

Review article:

Escandell JM, Pais DAM, Carvalho SB, Vincent K, Gomes-Alves P and Alves PM (2022) Leveraging rAAV bioprocess understanding and next generation bioanalytics development. Current Opinion in Biotechnology 74:271-277. doi: https://doi.org/10.1016/j.copbio.2021.12.009

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