Chromatographic process identification for protein C purification using frequency response analysis.
Frequency response analysis is applied for the analysis of liquid chromatography output of protein separation. Reduced data from simple chromatograms suggest that various Bode plot parameters, magnitude ratios, phase shift, the steady state gain, break frequency, and system order in the frequency domain, can be used to gain phenomenological insights on the system. Such an approach is advantageous because the validity of the model can be checked for two plots, the magnitude ratio vs. frequency and the phase shift vs. frequency, as compared to a single plot in the time domain. This approach also provides a useful empirical-tool which can be quantifiably used for process validation and scale-up, especially for immunoaffinity and immobilized metal affinity chromatographic systems used for protein C purification.
Chaubal
M V
MV
University of Maryland Baltimore County, Maryland 21228, USA.
Kang
K A
KA
Tadepalli
S S
SS
Drohan
W N
WN
Bruley
D F
DF
D000818:Animals; D001699:Biometry; D002417:Cattle; D002853:Chromatography, Liquid / Q000379:methods* / Q000706:statistics & numerical data; D006801:Humans; D015233:Models, Statistical; D011486:Protein C / Q000302:isolation & purification*; D012710:Serum Albumin, Bovine / Q000302:isolation & purification
D011486:Protein C; D012710:Serum Albumin, Bovine