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.
Virus Inactivation Tank
Ion Exchange Chromatography
Storage Tank and Diafiltration
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
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
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
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
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
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