Performance of a membrane adsorber for trace impurity removal in biotechnology manufacturing.
Membrane adsorbers provide an attractive alternative to traditional bead-based chromatography columns used to remove trace impurities in downstream applications. A linearly scalable novel membrane adsorber family designed for the efficient removal of trace impurities from biotherapeutics, are capable of reproducibly achieving greater than 4 log removal of mammalian viruses, 3 log removal of endotoxin and DNA, and greater than 1 log removal of host cell protein. Single use, disposable membrane adsorbers eliminate the need for costly and time consuming column packing and cleaning validation associated with bead-based chromatography systems, and minimize the required number and volume of buffers. A membrane adsorber step reduces process time, floor space, buffer usage, labor cost, and improves manufacturing flexibility. This "process compression" effect is commonly associated with reducing the number of processing steps. The rigid microporous structure of the membrane layers allows for high process flux operation and uniform bed consistency at all processing scales.
Phillips
Michael
M
Biopharmaceutical R&D Division, Millipore Corp., 32 Wiggins Ave, Bedford, MA 01730, USA.
Cormier
Jason
J
Ferrence
Jennifer
J
Dowd
Chris
C
Kiss
Robert
R
Lutz
Herbert
H
Carter
Jeffrey
J
D000327:Adsorption; D000818:Animals; D000911:Antibodies, Monoclonal; D001426:Bacterial Proteins / Q000302:isolation & purification; D017126:Bacteriophage phi 6 / Q000302:isolation & purification; D010584:Bacteriophage phi X 174 / Q000302:isolation & purification; D001435:Bacteriophages / Q000302:isolation & purification*; D001709:Biotechnology / Q000379:methods; D002852:Chromatography, Ion Exchange / Q000295:instrumentation / Q000379:methods*; D004247:DNA / Q000302:isolation & purification*; D004731:Endotoxins / Q000302:isolation & purification*; D004926:Escherichia coli / Q000821:virology; D006801:Humans; D006863:Hydrogen-Ion Concentration; D009052:Leukemia Virus, Murine / Q000302:isolation & purification; D008567:Membranes, Artificial; D051379:Mice; D008915:Minute Virus of Mice / Q000302:isolation & purification; D009994:Osmolar Concentration; D010865:Pilot Projects; D044205:Pseudomonas pseudoalcaligenes / Q000821:virology; D015203:Reproducibility of Results; D013539:Simian virus 40 / Q000302:isolation & purification
D000911:Antibodies, Monoclonal; D001426:Bacterial Proteins; D004731:Endotoxins; D008567:Membranes, Artificial; D004247:DNA