Electrophoresis of pharmaceutical proteins: Status quo

Abstract

The biotechnology industry has undergone rapid growth in recent years largely due to the development and success of protein-based therapeutics for a wide range of disorders. Similar to traditional pharmaceuticals, characterization of a therapeutic protein for its physicochemical properties, process monitoring and lot release is crucial. Electrophoresis in the slab-gel format has and continues to be a mainstay of the protein laboratory; and more recently, CE has begun to make significant inroads for protein analysis in industrial settings. This review focuses on the electrophoresis of proteins with an emphasis on protein-based therapeutics in the capillary, slab-gel and to a lesser extent, the microchip format. Reported applications of electrophoresis at several stages of the biopharmaceutical industry covering the period of 2000-2005 will be discussed.

Capillary electrophoresis of intact basic proteins using noncovalently triple‐layer coated capillaries

“…Over the last years, mAbs have been introduced for the treatment of several diseases, such as HIV, autoimmune disorders, and cancer (http://www.phrma.org/files/Biotech%202006.pdf, [23]). mAbs are subject to posttranslational modifications that occur during the production of the protein.…”

Mass spectrometry for glycosylation analysis of biopharmaceuticals

“…For example, in intact-protein glycoprofiling, electrophoretic methods without prior derivatization [e.g., capillary isoelectric focusing (CIEF), capillary-gel electrophoresis (CGE) and capillary-zone electrophoresis (CZE)] have become methods of choice in pharmacopeias and companies in the context of, e.g., product development, lot release and stability analyses [12,13]. Glyco-analysis at the protein level has the great advantage of reducing sample preparation to a minimum, thereby reducing costs and errors.…”

Proteomics Analysis of Kinetically Stable Proteins

“…8) . CE is an efficient and highly sensitive separation method that is widely used in biochemical and pharmaceutical research (Kostal, Katzenmeyer, & Arriaga, 2008;Little, Paquette, & Roos, 2006;McEvoy, Marsh, Altria, Donegan, & Power, 2008). CE is fast and cost-effective, and allows high sample throughput, easy automation, separation efficiency, precision, and only requires nanoliter volumes of sample (Dolnik, 2006(Dolnik, , 2008.…”