RT Journal Article
SR Electronic
T1 Studies on the Scale-Up of Crossflow Filtration Devices
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 252
OP 260
VO 50
IS 4
A1 Brose, Daniel
A1 Dosmar, Michael
A1 Cates, Steve
A1 Hutchison, Fred
YR 1996
UL http://journal.pda.org/content/50/4/252.abstract
AB This paper descrribes 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.