earticle

영어

The risk of virus contamination is a feature common to all biotechnology products derived from plasma, cell lines, or tissues of human or animal origin. To ensure the viral safety, the regulatory guidelines require that manufacturers of biological products for human use must demonstrate the capability of the manufacturing process to remove or inactivate known or adventitious viruses. Ultraviolet-C (UVC) irradiation has been known as an effective viral inactivating method since 1940s. Therefore there have been attempts to make UV irradiation systems to inactivate viruses for biopharmaceuticals. However the systems could not handle much transmissibility, and
provide low effective depth penetration, because UV irradiation intensity decreases exponentially with distance from the light source. Thus, liquid media were previously irradiated as thin films and required prolonged exposure times to ensure virus inactivation. Recently a new generation of continuous flow UVC reactor (UVivatec) has been designed by Bayer Technology Services to
eliminate the need for laminar flow thin films. In the Bayer Technology Services UV reactor, novel hydraulic spiral flow along an irradiation source induces highly efficient mixing in a fluid stream, so high doses of UVC irradiation can be delivered evenly and uniformly throughout the solution. Thus, the required residence times in the irradiation chamber are extremely short and UVC treatment is controllable. The purpose of the present study was to examine the efficacy of UVC irradiation using UVivatec system in the inactivation of viruses. A variety of experimental model viruses for human pathogenic viruses, including the human immunodeficiency virus (HIV), hepatitis A virus (HAV), bovine herpes virus (BHV), bovine viral diarrhea virus (BVDV), porcine
parvovirus (PPV), minute virus of mice (MVM), bovine parvovirus (BPV), reovirus type 3 (REO), bovine parainfluenza virus type 3 (BPIV), were selected for this study. Virus spiked solutions were treated with UVC with the intensities of 1,000 J/m2, 2,000 J/m2, and 3,000 J/m2, respectively. The viral titers before and after UVC irradiation were assayed using a 50% tissue culture infectious dose (TCID50). All the enveloped viruses except BHV were completely inactivated to undetectable levels by 3,000 J/m2 irradiation. Also all the non-enveloped viruses were completely inactivated to undetectable levels by 3,000 J/m2 irradiation. These results ndicate that UVC irradiation using UVivatec is a robust and effective method to inactivate viruses. [This research was financially supported by a research fund from CHA Bio & Diostech and the Ministry of Knowledge Economy (MKE) and Korea Industrial Technology Foundation (KOTEF) through the Human Resource Training Project for Strategic Technology.]