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Published byCasey Raines Modified over 10 years ago
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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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Solvent/Detergent (S/D) Inactivation Effective with lipid-coated viruses Disrupts the interactions between molecules in the lipid coat, rendering the coat dysfunctional and impeding replication Commonly used and has a reliable safety record Chemicals need to be removed downstream Pasteurization/Heat Effective with non-lipid and lipid-coated viruses Typically in a liquid at 60 o C for 10 hours Protein product must have a higher thermal resistance than the virus Requires the addition of stabilizers, which will need to be removed downstream Low pH Treatment Most effective with lipid-coated viruses Acidic conditions deactivate virus Protein product must have a higher resistance to low pH conditions than that of the viral particles No additional clearance steps are needed downstream
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Virus Inactivation Tank Ion Exchange Chromatography Storage Tank and Diafiltration
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StreamMass Flow Rate (kg/batch) ComponentMass Composition (%) Connection S-042 763.2967 Acetic acid Impurities mAb WFI 0.0784 0.1064 3.2681 96.5470 From storage tank S-045 0.153 Polysorbate 80 WFI 50.0000 Chemical inlet S-110 0.905 Nitrogen Oxygen 76.7118 23.2882 Vent to atmosphere S-046 763.449 Acetic acid Impurities mAb Polysorbate 80 WFI 0.0784 0.1064 3.2675 0.0100 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 852.88L Max Allowable Working Volume 90% Height/Diameter Ratio 3 Height 2.138m Diameter 0.713m Design Pressure1.52bar
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Supplier UsedNew Range of Cost For 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 CostsCost 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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