Review applications of capillary electrophoresis to the analysis of biotechnology-derived therapeutic proteins

Abstract

The number of proteins produced by recombinant DNA technology continues to grow at a rapid pace. In this review, the emphasis is on proteins that are of therapeutic interest. Aspects of protein analysis, such as glycoform separation of proteins produced in mammalian cells and the separation of oligosaccharides for structure elucidation, are covered. The use of antibodies as therapeutic proteins is growing and currently antibodies are the largest class of proteins produced by biotechnology. This has merited a separate section on analysis of antibodies by capillary electrophoresis (CE). Applications of mass spectrometry as an ancillary technique, used in conjunction with CE, are also covered briefly. This review covers the literature since 1999.

Analysis of recombinant human growth hormone by capillary electrophoresis with bilayer-coated capillaries using UV and MS detection

“…Nowadays, more than 100 pharmaceutical proteins have been approved for marketing and several hundreds are currently in clinical trials [1]. This development increases the demand for suitable methods of analysis that allow not only the separation and quantification of impurities and possible degradation products, but also their identification and, preferably, their physicochemical characterization [2][3][4]. Regulatory authorities demand a thorough characterization and control of the quality attributes of biopharmaceutical products from the early stages of clinical investigation up to commercial scale production.…”

Profiling preparations of recombinant birch pollen allergen Bet v 1a with capillary zone electrophoresis in pentamine modified fused-silica capillaries

“…CE provides a valuable tool in tackling problems related to biotechnologically derived products, due to its high efficiency and the versatility, which is related to the availability of different electrophoretic separation modes, i.e., capillary zone electrophoresis (CZE), capillary isotachophoresis (CITP), capillary micellar electrokinetic chromatography (MEKC) and capillary isoelectric focusing (CIEF). Recent reviews provide a comprehensive survey of these fields of application [22][23][24][25].…”

Influence of ignored and well-known zone distortions on the separation performance of proteins in capillary free zone electrophoresis with special reference to analysis in polyacrylamide-coated fused silica capillaries in various buffers

“…Capillary electrophoresis is growing as one of the most powerful analytical techniques for the separation of proteins and peptides due to inherent advantages of the method, such as very high resolution, high separation efficiency, short analysis times, minimal sample volume requirement, and automated instrumentation [2][3][4][5][6][7]. Capillary electrophoresis of proteins has recently been reviewed [4][5][6][7].…”

“…Capillary electrophoresis of proteins has recently been reviewed [4][5][6][7]. An obstacle to such separations is the interaction of the negatively charged silanol groups on the capillary surface with positively charged proteins, leading to loss of efficiency, poor reproducibility in migration times, low protein recovery and decreased sensitivity [2,4].…”