Scientists have successfully adapted an adherent HEK293 cell line to grow in animal component-free and serum-free suspension conditions in shaker flasks. After comparing adherent, suspension, and microcarrier culture for AAV production, they believe that microcarrier culture is suitable for large-scale production of viral vectors to support future gene therapy manufacturing processes.
Virus filtration is a critical operation in many biologic production processes and a key component of most viral safety strategies. Viresolve® Pro devices are released to a specification that provides at least 4.0 logs of small virus, such as parvovirus, removal. This document provides information on virus retention performance of Viresolve® Pro devices and is framed in the context of a process design space within which the filters would be expected to operate.
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A mid-to-large biopharma wanted to increase productivity 2-3× in their fed-batch facility and and also reduce their current cost of goods (COGS). With one small change in the upstream (USP) seed train, the customer was able to meet their goals.
Unlocking the full potential of viral-vector based therapies requires an understanding of existing challenges in viral vector production and which technologies are now available in upstream and downstream processing to help address them.
A large biopharma company wanted to establish a single-use multi-product facility by choosing appropriate upstream processes that can deliver more than 500 kg/year throughput. This case study shows how a concentrated fed-batch process was established, enabling higher productivity and increasing the throughput (up to 4× higher titer than standard fed-batch), providing more flexibility for production runs.