Биопрепараты: Профилактика, диагностика, лечение (Feb 2018)
Experimental study of the effectiveness of the removal of virus hepatitis B, C and parvovirus B19 by the fractionation of blood plasma with ethanol
Abstract
The purpose of the study was to assess the effectiveness of the removal of nucleic acids (NA), Hepatitis B (HBV) and C (HCV) viruses and parvovirus B19 (B19V) from blood plasma fractions obtained by alcohol separation. The studies were performed in a model experiment by fractionation normal pool plasma donation contaminated with virus-containing samples in the laboratory. It was found that the multi-step process to extract a fraction II, designed to provide the immunoglobulin G, provided the elimination of NA HBV and HCV to undetectable levels by PCR, and the total reduction factor compared to the original composition of the plasma HBV DNA >5.35 log, HCV RNA >4.84 log. Factor DNA V19V reduction was at the level of 4.56 log(CI 4.49-4.63). Upon receipt of the fraction V (for albumin) reduction factor of the test virus was >3.0 log wich in combination with additional purification step provides a reliable level of safety. The selection fraction I resulted in effectiveness of the elimination of HBV DNA and V19V DNA less than 2 orders, HCV RNA - less than 3 orders of magnitude, it is not enough to recognize the stage reliable. Experiments confirmed that the high risk of contamination of production pools parvovirus B19 additional safety measures are necessary, including mandatory investigation of plasma DNA V19V. In general the development of a full cycle of drug from blood plasma from donors, basic process alcohol fractionation steps necessary to supplement validation virus elimination and inactivation considering residual risk of contamination with pathogenic agents feedstock.
