A comparison of analytical techniques for the determination and monitoring of charge variants in therapeutic proteinsKropušek, Eva (Avtor) Finšgar, Matjaž (Mentor) Majer, David (Komentor) Birk, Matej (Komentor) Imaged capillary isoelectric focusingcapillary zone electrophoresiscation exchange chromatographycharge variantsbiological drugCharge variants of therapeutic proteins are considered to be drug product variants and process-related impurities. To monitor charge heterogeneity, the development of a new analytical method is needed. Imaged capillary isoelectric focusing, capillary zone electrophoresis, and cation exchange chromatography assays were evaluated as candidate assays to support the early development of two new biological drug candidates. These are the analytical techniques most frequently used in the pharmaceutical industry for monitoring charge heterogeneity. We compared the advantages and disadvantages of these analytical techniques for monitoring charge variants in two innovative monoclonal antibodies. The results obtained revealed similarities and differences in the various analytical techniques. However, there is only a short time-frame dedicated to analytical method development when developing new biological drugs. With this in mind, imaged capillary isoelectric focusing showed a perfect balance between the quality and speed of analysis.[E. Kropušek]20232023-09-03 16:55:00Magistrsko delo/naloga85587UDK: 543.54:547.96(043.2)COBISS_ID: 171233795sl