Inactivation of lipid-enveloped viruses in proteins by caprylate

Area of Science:

• Biochemistry
• Virology
• Biopharmaceutical Manufacturing

Background:

• Lipid-enveloped viruses pose a significant risk in biopharmaceutical production.
• Existing methods for virus inactivation can compromise protein integrity and yield.
• A need exists for efficient and gentle virus inactivation strategies.

Purpose of the Study:

• To evaluate caprylate as a method for inactivating lipid-enveloped viruses in biologically active proteins.
• To assess the impact of caprylate treatment on protein integrity and biological activity.
• To determine the optimal conditions for caprylate-mediated virus inactivation.

Main Methods:

• Lipid-enveloped viruses (herpes simplex virus type I, vesicular stomatitis virus, vaccinia virus, Sindbis virus) were used for spiking.
• Caprylate concentration and pH were manipulated to maintain a specific level of the non-ionized form.
• Virus-spiked protein solutions were treated with caprylate under various conditions.
• Post-treatment, caprylate was removed using size exclusion chromatography or ion exchange adsorption.

Main Results:

• Caprylate rapidly inactivated tested lipid-enveloped viruses across a range of conditions.
• Protein integrity and biological activity were largely maintained, with near-quantitative yields.
• An exception was noted for coagulation factor AHF, which showed reduced yield.
• Caprylate removal was achieved efficiently through chromatography or adsorption.

Conclusions:

• Caprylate is a potent agent for inactivating lipid-enveloped viruses in protein solutions.
• The method preserves the biological activity and integrity of most proteins.
• Caprylate treatment followed by purification offers a viable strategy for virus clearance in biopharmaceutical processes.