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VIRUS INACTIVATION

VIRUS INACTIVATION. By: Goldie Wong, Melanie Wong & Sarah Wong. Purpose and Mechanism. Virus inactivation involves dismantling a virus’s ability to infect cells without actually eliminating the virus. Viruses can be lipid-coated or non-enveloped.

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VIRUS INACTIVATION

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  1. VIRUS INACTIVATION By: Goldie Wong, Melanie Wong & Sarah Wong

  2. Purpose and Mechanism Virus inactivation involves dismantling a virus’s ability to infect cells without actually eliminating the virus. Viruses can be lipid-coated or non-enveloped. Virus inactivation works by one of the following two mechanisms: • By attacking the viral envelope or capsid and destroying its ability to infect or interact with cells. • By disrupting the viral DNA or RNA and preventing replication. FDA specifies that a clearance of at least 3 logs must be achieved for mAb production.

  3. Methods of Virus Inactivation

  4. Virus Inactivation Tank Storage Tank and Diafiltration Ion Exchange Chromatography

  5. The Unit Operation

  6. SuperPro® Simulation • There was no way to measure concentrations of active and inactive viruses • Manipulating temperature, holding time, and flow rates had very little effect in our simulated unit • Theoretically, a longer holding time and a higher S/D concentration should results in higher levels of inactivation • The volume increased minimally as the detergent concentration increased

  7. Sizing

  8. Capital Cost

  9. Operating Cost Simulation Unit Operation: In Place Steaming  Transfer In  Pull In  Holding  Transfer Out  In Place Cleaning Operating conditions • Steam: normal pressure, 42.5 kg/batch • Polysorbate 80: 0.0765 kg/batch

  10. Final Recommendations • Develop a way to simulate active and inactive virus concentrations • Optimize for temperature, holding time, and S/D concentration • Polysorbate 80 concentration of 0.01-1.0 wt% • Purchase a used blending tank from Aaron Equipment Company for $8000

  11. Questions

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