Liquid chromatographic control of the identity, purity and "potency" of biomolecules used as drugs.
The use of high-performance liquid chromatography (HPLC) in the control of rDNA-derived human insulin and human growth hormone is described. Powerful identity tests based upon reversed-phase HPLC separation of enzymatic digests have been developed. Size exclusion and reversed-phase assays are used to control higher molecular weight materials and monomeric derivatives, respectively, for both proteins. Finally, HPLC is used to control the relevant protein content, which in concert with other information controls the biopotency of the protein preparations.
Farid
N A
NA
Eli Lilly and Company, Indianapolis, IN 46285.
Atkins
L M
LM
Becker
G W
GW
Dinner
A
A
Heiney
R E
RE
Miner
D J
DJ
Riggin
R M
RM
D002851:Chromatography, High Pressure Liquid; D013006:Growth Hormone / Q000032:analysis* / Q000235:genetics; D006801:Humans; D007328:Insulin / Q000032:analysis* / Q000235:genetics; D011994:Recombinant Proteins / Q000032:analysis / Q000235:genetics
D007328:Insulin; D011994:Recombinant Proteins; D013006:Growth Hormone