VIRUS INACTIVATION

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VIRUS INACTIVATION

• By Goldie Wong, Melanie Wong Sarah Wong

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Purpose and Mechanism
Virus inactivation involves dismantling a viruss
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.
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Methods of Virus Inactivation
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Virus Inactivation Tank
Storage Tank and Diafiltration
Ion Exchange Chromatography
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The Unit Operation
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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

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Sizing
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Capital Cost
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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

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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

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Questions