monoclonal antibody analysisFeaturing three peer-reviewed articles on monoclonal antibody (MAb) analysis from the latest issue of our Biopharma Solutions enewsletter (more on the enewsletter plus a link on subscribing to it at the end of this post).

Article: Accurate Determination of Succinimide Degradation Products Using High Fidelity Trypsin Digestion Peptide Map Analysis

The formation of byproducts, such as succinimide, is quite common during the MAb degradation process and, therefore, need to monitored. In this journal article, Genentech scientists detail their research in the detection and characterization of succinimide-containing variants in MAbs to determine their functional effects on biological activity. They used our mass spectrometer (Thermo Scientific LTQ-XL Orbitrap Mass Spectrometer) to perform high-fidelity peptide mapping and used the resulting high resolution/accurate mass (HR/AM) MS data to detect and estimate levels of each succinimide variant species.

Article: Enhancement of therapeutic monoclonal antibody production in CHO cells using 30Kc6 gene

When manufacturing MAbs, optimizing cell cultures is essential to maximize MAb production and improve product quality, especially with large-scale cultures. In this study, researchers discovered that you can prolong cell life span by harvesting cells that over-express anti-apoptotic genes and then depriving these lines of serum during the culturing process. By growing these specialized reengineered CHO cultures in serum-free medium, researchers were able to inhibit cellular apoptosis and increase MAb production.

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Article: Characterization of a unique IgG1 mAb CEX profile by limited Lys-C proteolysis/CEX separation coupled with mass spectrometry and structural analysis

Increased regulatory expectations on the characterization of MAb impurities and charge heterogeneity make it essential to compile a complete stability profile of the biologic in the drug development process. In this study, Amgen researchers used our protein cation-exchange column (Thermo Scientific Dionex ProPac WCX-10) column to identify a unique MAb charge variant profile and take a more in-depth look at the protein’s stability. This particular aglycosylated MAb exhibited an unusual cation-exchange chromatography (CEX) profile, highlighted by a heightened amount of acidic species. The ProPac WCX-10 column proved to provide the sensitivity and resolution required to separate this unique profile. When coupled with MS, the method provides comprehensive stability analysis that can be used for characterizing MAbs. (Here is a downloadable 2-page PDF of Tips & Tricks Guide on Improving the Performance of the ProPac WCX-10 column.)

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