Pathogen Inactivation for Blood Products, Protein Therapeutics, and Vaccines – CFI

For the physical inactivation of enveloped and non-enveloped viruses with no residual contamination and negligible denaturation of proteins and enzymes

CFI Mechanisms of Inactivation

CFI has the ability to physically disrupt and inactivate pathogen particles, explaining its ability to inactivate non-enveloped viruses such as Polio and a variety of tough microorganisms such as yeast and other Gram-positive microorganisms.

CFI also inactivates enveloped viruses, such as HIV and influenza, by a partial phospholipid solubilization/liberation mechanism.

CFI of enveloped viruses such as MuLV, VSV, TGE, BVD, Sindbis and HIV, and non-enveloped viruses such as Hepatitis A, Polio, Adeno, Reo, EMC and Parvovirus B19 has been demonstrated.

In summary, CFI:

• Disrupts and inactivates bacterial and other pathogens
• Inactivates both enveloped & non-enveloped viruses
• Employs no chemicals and non-toxic solvents
• Is a rapid technique (> 6 logs in less than 20 seconds for some viruses)
• Operates at low temperatures (10 to 50°C)
• Is competitive in terms of processing costs
• Is applicable to liquids and solids
• Is scalable and amenable to continuous operation

CFI can inactivate a broad range of enveloped and non-enveloped viruses, more than 6 logs (1 million particles per milliliter) in less than 20 seconds for some viruses. Increasing the number of stages, like a distillation column, increases inactivation levels. Volumetric throughput is increased by increasing cross-sectional area.

CFI Applications

• CFI can be used for the virus clearance of human plasma, immunoglobulins, and other blood products, fetal bovine serum, monoclonal antibodies as well as transgenic and recombinant therapeutics.
• CFI can be applied to protein-rich solutions and powders as well as solids such as medical implants and bones.
• CFI can also be used for the manufacturing of therapeutic and prophylactic vaccines for animals and humans use.