Inactivation of BVDV (experimental model for hepatitis C) using low pH and heat treatment in intravenous human immunoglobulins
Ruibal Brunet, I.J.; Noa Romero, E.; Rivero Mas, A.T.; Martín García, R.Z.
Sangre 44(5): 352-356
1999
ISSN/ISBN: 0036-4355 PMID: 10618912 Document Number: 6970
To measure the capability of heat (60 degrees C for 10 hr) and low pH to inactivate BVDV (a model of HCV) in human intravenous immunoglobulins. The study was carried out on three batches of immunoglobulins produced by the Cohn method and contaminated with a known amount of BVDV. These mixtures, with and without 33% sorbitol, were submitted to heat treatment at 60 degrees C for 10 hours. The same immunoglobulin batches were manufactured at pH 4.25 and 4.5 and stored at 4 degrees C and 4 degrees C and 21 degrees C for 28 days. Samples of the two experiments were taken at the beginning and the end. The viral infectiousness was calculated by the standard microtiration method in 96-well plates, using the CPE, and the reduction factor was measured for each experiment. Complete viral inactivation was achieved with the heat treatment after 4 hours, and the 33% sorbitol decreased the formation of aggregates. Treatment by pH 4.5, at 21 degrees C for 28 days, decreased the viral load by approximately 2 log; no viral inactivation was achieved in samples stored at 4 degrees C. Heat is an effective method for inactivating HCV in final batches of human intravenous immunoglobulins when 33% sorbitol is added. The use of low pH at 21 degrees C as a method of viral inactivation must be evaluated case by case, since, according to the present results, it only achieved a 2 log inactivation.
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