| Title: | A comparison of analytical techniques for the determination and monitoring of charge variants in therapeutic proteins : master's thesis |
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| Authors: | ID Kropušek, Eva (Author)
ID Finšgar, Matjaž (Mentor) More about this mentor... 
ID Majer, David (Comentor)
ID Birk, Matej (Comentor) |
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| Files: |  MAG_Kropusek_Eva_2023.pdf (3,02 MB)
MD5: 1F2DE87A8D0498694D6BAFF465824C83
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| Language: | English |
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| Work type: | Master's thesis/paper |
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| Typology: | 2.09 - Master's Thesis |
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| Organization: | FKKT - Faculty of Chemistry and Chemical Engineering
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| Abstract: | Charge 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. |
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| Keywords: | Imaged capillary isoelectric focusing, capillary zone electrophoresis, cation exchange chromatography, charge variants, biological drug |
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| Place of publishing: | Maribor |
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| Place of performance: | Maribor |
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| Publisher: | [E. Kropušek] |
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| Year of publishing: | 2023 |
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| Number of pages: | 1 spletni vir (1 datoteka PDF (XII, 61 f.)) |
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| PID: | 20.500.12556/DKUM-85587 |
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| UDC: | 543.54:547.96(043.2) |
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| COBISS.SI-ID: | 171233795 |
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| Publication date in DKUM: | 03.10.2023 |
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| Views: | 784 |
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| Downloads: | 65 |
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| Metadata: |    |
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| Categories: | KTFMB - FKKT
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