Viruses can be lipid-coated or non- enveloped. Virus inactivation works by one of the following two...
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![Page 1: 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.](https://reader036.fdocuments.in/reader036/viewer/2022062313/56649c8e5503460f9494700a/html5/thumbnails/1.jpg)
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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.
Virus inactivation involves dismantling a virus’s ability to infect cells without actually eliminating the virus.
FDA specifies that a clearance of at least 3 logs must be achieved for mAb production.
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Virus Inactivation Tank
Ion Exchange Chromatography
Storage Tank and Diafiltration
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Stream Mass Flow Rate
(kg/batch)
Component Mass Composition
(%)
Connection
S-042
763.2967
Acetic acidImpurities
mAbWFI
0.07840.10643.2681
96.5470
From storage tank
S-0450.153
Polysorbate 80 WFI
50.000050.0000
Chemical inlet
S-1100.905
NitrogenOxygen
76.711823.2882
Vent to atmosphere
S-046
763.449
Acetic acidImpurities
mAbPolysorbate 80
WFI
0.07840.10643.26750.0100
96.5377
To polishing filter
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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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SuperPro® Specification for
Polysorbate80 at 0.01% wt
Value
Volume 852.88 LMax AllowableWorking Volume
90 %
Height/Diameter Ratio 3Height 2.138 mDiameter 0.713 mDesign Pressure 1.52 bar
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Supplier
Used NewRange of CostFor Tank with
agitator
Cost for Mixing Unit
Cost for Tank
without agitator
Total Cost of Tank and Agitator
Machinery and Equipment Company, Inc.
$12,500.00
$25,000.00 - $100,000.00
Aaron Equipment Company
$8,500.00 - $10,000.00
Slimline Manufacturing
$1,000.00
$127,500.00
$128,500.00
Pope Scientific Inc.
$11,000.00
Apache Stainless Equipment Corporation
$15,000.00
$20,000.00
$35,000.00
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Operating Costs Cost
Steam (per batch) $0.18
Polysorbate 80 (per batch) $2.32
Usage Rate (per equipment-hr) $2,088.00
Labour Hours (labour hrs/hr) 8
TOTAL $2,090.50 + 8 Labour Hours
Operating conditions Steam: normal pressure, 42.5 kg/batch Polysorbate 80: 0.0765 kg/batch
Simulation Unit Operation: In Place Steaming Transfer In Pull In Holding Transfer Out In Place Cleaning
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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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