New therapies, medicines and cutting-edge technology have enabled the production of next generation treatments that improve patient care, simplify administration and increase the availability of life changing medicine. One of the new technologies emerging in the biopharmaceutical manufacturing market is the use of viral vectors for cell and gene therapy. Intriguingly, using lentivirus as a means of pharmaceutical production represents a new area for bioprocessing development due to its specific issues, especially during required purification unit operations such as clarification. Particle size and surface charge variability are among what causes difficulty while clarifying lentivirus harvest; PD groups are seeing significant losses in virus titer yield post-clarification. Typical clarification techniques rely on size exclusion and adsorption to isolate a filtrate from impurities. A large portion of clarification filters on the market are designed with monoclonal antibodies in mind – depth filter media tends to have a chemistry that will bind lentivirus, and tighter depth filters will remove the lentivirus based on size exclusion. The typical diameter of a lentivirus is the perfect size to be removed by the most common depth filters. This work explores a variety of lentivirus harvest clarification options and items for consideration during manufacturing platform development of viral therapy production using adherent and suspension cell lines.

Considerations for development of a platform Lentivirus harvest clarification process for cell and gene therapy

2019 Spring National Meeting

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