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