RT Journal Article
SR Electronic
T1 Cumulative Viral Titer Reduction Demonstrated by Sequential Challenge of a Tangential Flow Membrane Filtration System and a Direct Flow Pleated Filter Cartridge
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 208
OP 212
VO 51
IS 5
A1 Hazel Aranha-Creado
A1 G. J. Fennington, Jr.
YR 1997
UL http://journal.pda.org/content/51/5/208.abstract
AB The efficiency of sequential incorporation of two approaches to virus removal, i.e., tangential flow ultrafiltration using the Omega™ 300K VR Maximate™ System, and, direct flow microfiltration using the Ultipor® VF™ grade DV50 virus removal filter, was evaluated using bacteriophage Φ6 in Dulbecco's modified Eagle medium (MEM) as the carrier fluid. A combined log titer reduction value of >10 was demonstrated, with each step, individually, providing >4.5 log reduction. Significant improvement in filter life was also demonstrated when the combined system was used. The data suggest that this system may have applications in the manufacture of biologicals and biopharmaceuticals, where there is a requirement for multiple robust methods of virus removal to ensure freedom from endogenous or adventitious viral contamination.