Premium
Chromatographic removal and heat inactivation of hepatitis B virus during the manufacture of human albumin
Author(s) -
Adcock Wayne L.,
MacGregor Andrew,
Davies Jeff R.,
Hattarki Meghan,
Anderson David A.,
Goss Neil H.
Publication year - 1998
Publication title -
biotechnology and applied biochemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.468
H-Index - 70
eISSN - 1470-8744
pISSN - 0885-4513
DOI - 10.1111/j.1470-8744.1998.tb00527.x
Subject(s) - chromatography , hbsag , pasteurization , fractionation , hepatitis b virus , chemistry , albumin , ultrafiltration (renal) , sepharose , size exclusion chromatography , virus , biochemistry , virology , biology , enzyme
The purpose of the present study was to examine the efficacy of the chromatographic and pasteurization steps, employed in the manufacture of human albumin, in the removal and/or inactivation of hepatitis B virus (HBV). Most human albumins manufactured today are prepared from donor plasma by fractionation methods that use precipitation with cold ethanol. CSL Limited, an Australian biopharmaceutical company, has recently converted its method of manufacture for albumin from a traditional Cohn fractionation method to a method employing chromatographic techniques. A step‐by‐step validation of virus removal and inactivation was performed on this manufacturing process, which includes a DEAE‐Sepharose® and CM‐Sepharose® Fast Flow ion‐exchange step, a Sephacryl® S200 High‐Resolution gel‐filtration step and a bulk pasteurization step where product is held at 60 °C for 10 h. HBV partitioning experiments were conducted on scaled‐down chromatographic columns with hepatitis B surface antigen (HBsAg) as a marker, whereas the HBV model virus, duck HBV, was used to study the inactivation kinetics during pasteurization. Reductions for HBsAg through the three chromatographic steps resulted in a total log 10 decrease of 1.5 log 10 , whereas more than 6.5 log 10 decrease in duck HBV in Albumex®5 was achieved during pasteurization.