Evaluation of anti-viral filters.
The purification processes used to prepare medicines from human and animal cell lines provide one of the major opportunities for virus risk reduction. The purification process can be validated for its ability to remove a range of viruses and can be shown to provide a significant barrier to the transmission of viruses from cell substrates and raw materials to the patient. Ultrafiltration membranes which are manufactured with extremely tight control on pore size distribution can remove a broad spectrum of viruses with high efficiency. A scheme is described for the evaluation of anti-viral filters and the results from evaluation of two filters are presented. The experiments carried out with ultrafiltration membranes suggest that they can provide significant additional virus risk reduction factors for biopharmaceuticals.
Hughes
B
B
Glaxo-Wellcome Biotechnology, Beckenham, Kent, UK.
Bradburne
A
A
Sheppard
A
A
Young
D
D
D000818:Animals; D001688:Biological Products / Q000592:standards; D002460:Cell Line / Q000821:virology; D004340:Drug Contamination / Q000517:prevention & control; D005374:Filtration / Q000379:methods*; D006801:Humans; D015203:Reproducibility of Results; D013678:Technology, Pharmaceutical / Q000379:methods*; D014780:Viruses / Q000302:isolation & purification*
D001688:Biological Products