Current trends in the biotechnology realm show the rapid growth of the use of viral vectors for gene therapy as one of the next generation of life changing medicines. rAAV (recombinant Adeno-associated virus) has become a popular viral vector that is able to deliver targeted genetic information to a patient and is considered non-pathogenic and safe for these patients to be treated with. Due to the life changing nature of these therapies to the patient population, the need for rapid and robust purification and manufacturing methods is a must. A key step in the purification and manufacturing of rAAV viral vectors is the clarification step. A typical rAAV manufacturing process will lyse transfected cells, releasing the rAAV viral vectors from the cell, producing a wide particle range of cellular debris that must be removed prior to moving forward in the purification process. During the early stages of developing a clarification method for a rAAV manufacturing process, it is crucial to select the correct depth filtration media that will maximize rAAV yield and provide reproducible quality filtrate. The work to be presented, focuses on the development of a clarification step by testing combinations of MilliporeSigma’s Millistak+® HC D0HC and Millistak+® HC Pro D0SP as primary depth filters and Millistak+® HC C0HC and Millistak+® HC Pro C0SP as secondary depth filters with a lysed cell culture feed containing rAAV9. A comparison of pressure profiles, volumetric throughput, turbidity of filtrate, and product yield was used to determine the optimal combination of primary and secondary depth filters. All filtration trains tested provided high quality filtrate which had high capacity on Express SHC® sterile grade filter, though total yield of product (&gt;80%) suggests Millistak+® HC D0HC and Millistak+® HC Pro D0SP as good choices for a primary depth filter followed by Millistak+® HC C0HC as the secondary depth filter as the best option for the feed tested.

Development of a rAAV clarification platform for a viral gene therapy process

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.