Methods and systems for manufacturing viral vectors

Abstract

Disclosed herein are methods and systems for manufacturing viral vectors (e.g., lentiviral vectors) using a static light scattering device in series with the manufacturing process.

Description

[0001] related application [0002] This application claims the benefit of U.S. Provisional Application No. 62 / 795,513, filed January 22, 2019, the contents of which are incorporated herein by reference in their entirety. Background technique [0003] Gene therapy using viral vectors is an area that has attracted significant attention. However, the ability to efficiently manufacture large quantities of viral vectors remains an issue. Currently there are no in-line process analytical technology (PAT) solutions for detection or quantification of viral vectors during the manufacturing process. There is also no in-line process for controlling the separation of non-infectious particles from infectious particles during the manufacturing process. Quantification and characterization of viral vectors often requires lengthy assays, which prevent real-time decision-making during the manufacturing process. Furthermore, currently no tandem solution exists to control the separation of in...

AI Technical Summary

Problems solved by technology

Quantification and characterization of viral vectors often requires lengthy assays, which prevents real-time decision-making during the manufacturing process

Furthermore, currently no tandem solution exists to control the separation of intact viral vector particles from their process-specified impurities such as exosomes

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