Studies on the scale-up of crossflow filtration devices.
This paper describes a new method that makes it possible to predict the performance of crossflow ultrafiltration and microfiltration when scaling up from small laboratory scale to process-scale systems. Using this method, one characterizes a solution's filtration properties with a specific ultrafiltration or microfiltration membrane in a laboratory-scale crossflow device. Based on experimental results at this scale, one can accurately predict scale-up performance from laboratory through clinical production to full marketing production. Given the need for biopharmaceutical engineers to rapidly predict the size and cost of full-scale filtration processes once products receive regulatory approval, this method will find wide use in the pharmaceutical industry.
Brose
D
D
Chemica Technologies, Incorporated, Bend, Oregon 97701-5711, USA.
Dosmar
M
M
Cates
S
S
Hutchison
F
F
D004345:Drug Industry; D011237:Predictive Value of Tests; D012996:Solutions; D014462:Ultrafiltration / Q000295:instrumentation / Q000379:methods*
D012996:Solutions