A complete structural insight in biosimilars is critical to the safeguarding of drug efficacy and safety. Understanding biopharma charge heterogeneity requires proven workflows that ensure simple yet confident protein characterization, from discovery to QC. It requires understanding the complex nature of these beautiful molecules in order to apply the right separation technique, employing the correct columns and consumables and thus save time, increase productivity and reproducibility.
If you think that routinely characterizing biosimilar charge variants is far from a creative art, then look at these 10 reasons before deciding just how fine is the art of variant separation:
- Characterization of therapeutic proteins using Ion-exchange requires utilization of the latest advancements in analytical technology. Find out how the Thermo Scientific™ ProPac™ Elite WCX weak cation exchange column can provide your laboratory with high resolution charge variant separations.
- Addressing the challenging charge variants separations requires know-how in selecting the right column chemistry. Our brochure celebrates our rich history in Bio LC columns, highlights key liquid chromatography columns and provides example applications demonstrating exceptional column performance.
- Your chosen unique column chemistry needs to provide the excellent lot-to-lot reproducibility, high recovery and low carryover for characterization of therapeutic proteins, monoclonal antibodies (mAb), antibody drug conjugates (ADCs) and biosimilar proteins. View our product specifications to learn more.
- You continuously seek to simplify your charge variant separation method development for easy optimization. The Thermo Scientific™ CX-1 pH Gradient Buffer Kits were introduced to simplify method development. The kits contain two different mobile phases with two different pHs, which enables you to use a linear pH gradient method to quickly separate mAb charge variants.
- For high productivity your method transfer needs to be quick and effortless. A novel pH gradient method for ion-exchange chromatography that proves fast and reproducible for monoclonal antibody (mAb) charge variant profiling is discussed in this application note; pH Gradient Analysis of IgG1 Therapeutic Monoclonal Antibodies Using a 5µm WCX Column
- Where possible, you run fast and confident profiling routine without loss of resolution. Currently, because the mobile phases we use contain salts, direct coupling to a mass spectrometer is usually not recommended for any charge variant analysis. Check out our new Salt Gradient Analysis of IgG1 Monoclonal Antibodies Using a 5µm WCX Chromatography for a detailed method development to demonstrate high-resolution analysis of IgG1 therapeutic mAbs using salt gradient with the Thermo Scientific ProPac Elite WCX column.
- You strive to demonstrate high-resolution separation of IgG1, IgG2, IgG3 and IgG4 therapeutic mAbs, which are used to treat many diseases including rheumatoid arthritis, Alzheimer’s disease, and different types of cancers. Charge heterogeneity of two challenging immunoglobulins IgG2 and IgG4 were analyzed using the ProPac Elite WCX column. This application note demonstrates the high resolving power when using a shallower gradient method to resolve more than 15 structural isoforms and charge variants.
- You strive to reduce any risk of method variability for simplified ion exchange analysis (IEX) of charge variants when using a pH gradient. The following application note is evaluating an application of salt- and pH-based ion-exchange chromatography gradients for analysis of therapeutic mAbs.
- You are a confident charge variant evaluator of biosimilars obtained in a single analysis. This simple charge variant profile comparison demonstrates the effectiveness of a simple pH gradient/ion-exchange chromatography workflow approach to the characterization of the different charge variants profiles of an innovator molecule (cetuximab) and a candidate biosimilar. The combination of the Thermo Scientific CX-1 pH gradient buffer, MAbPac™ SCX-10 column, and the Vanquish Flex UHPLC provides excellent separation of charge variants from bio-therapeutics with excellent retention time precision.
- You continuously keep on top of information about the latest developments. This on-demand webcast is focusing on the new weak cation exchange method design and advancements in resin chemistries, and how to speed up charge variant analysis to 10 minute separations for high throughput analysis.
If you are a biopharma researcher interested in the characterization of therapeutic proteins, including monoclonal antibodies, fusion proteins and biosimilar therapeutics, you are likely to be a fine artist, determined to master the simple, reproducible and easily optimized analytical methods that resolve charge variants effectively.Additional Resources