Detection and consequences of recombinant protein isoforms: implications for biological potency.
Protein isoforms commonly occur in nature and in products produced by recombinant DNA technologies. Some isoforms may be generated as a consequence of the manufacturing process. Bioassay methods may not be sufficiently sensitive enough or specific enough to determine the biological effect of having a new or increased level of a particular isoform. Sophisticated analytical techniques exist for the structural characterization of protein isoforms. The biological implications of these isoforms are not easy to determine. Additional "Biological Characterization" work may need to be done to evaluate the biological consequences of isoforms. An understanding of the product's mechanism of action and the disease mechanism of action is essential for a thorough evaluation.
Federici Jamrogowicz
M M
MM
Biopharmaceutical Development, GlaxoSmithKline, King of Prussia, PA 19406, USA.
Venkat
K
K
Bam
N
N
Dal Monte
P R
PR
Fernie
B
B
Patel
K
K
D004591:Electrophoresis, Polyacrylamide Gel; D004797:Enzyme-Linked Immunosorbent Assay; D007525:Isoelectric Focusing; D020033:Protein Isoforms / Q000737:chemistry* / Q000494:pharmacology; D011994:Recombinant Proteins / Q000737:chemistry* / Q000494:pharmacology
D020033:Protein Isoforms; D011994:Recombinant Proteins