Capillary electrophoresis of proteins in a quality control environment.
A method for determining the purity of recombinant carboxypeptidase B utilizing CE-SDS has been developed and validated for use in a manufacturing quality control laboratory. The method was optimized, prior to validation, to allow for the lowest limit of quantitation. The method was validated with the typical ICHQ2A parameters, including accuracy, linearity, LOQ, precision, robustness/ruggedness, and specificity. All validation parameters met the acceptance criteria defined in the validation protocol.
Good
David L
DL
Indianapolis Bulk Operations Technical Excellence Centre, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN., USA.
Cummins-Bitz
Stacey
S
Fields
Raeann M
RM
Nunnally
Brian K
BK
D043424:Carboxypeptidase B / Q000737:chemistry*; D019075:Electrophoresis, Capillary / Q000379:methods; D004591:Electrophoresis, Polyacrylamide Gel; D011786:Quality Control; D011994:Recombinant Proteins / Q000737:chemistry*; D012680:Sensitivity and Specificity; D012967:Sodium Dodecyl Sulfate / Q000737:chemistry*
D011994:Recombinant Proteins; D012967:Sodium Dodecyl Sulfate; D043424:Carboxypeptidase B