CEInfinite
CEInfinite Preparative facilitates charge variant characterization by direct MS-detection and automated fractionation. CEInfinite is a whole column imaging CIEF, which allows fast method development and high throughput compared to traditional CE. The system is known for its robustness and is FDA CFR 21 Part 11 compliant
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Charge variant automated fractionation facilitating:
- MS-characterization of each isoform
- Petide mapping of each isoform
- SPR analysis of the charge variants
Direct MS-coupling
- Isoform analysis using MS deconvolution
- Batch to batch variance analysis characterization
On board mixing tool:
- Fully robotized unattended high throughput analysis of sample
- Formulation studies
- Stability studies
Analytical whole column imaging CIEF setup:
- Fast method development
- High throughput analysis of samples
- Batch to batch variation
- Charge variant quantification
- Charge distribution assays
- Relative pI determination of isoforms
Separation and characterization of NISTmAb charge variants with CEInfinite on-line iCIEF-MS
On-line iCIEF-MS coupling using the CEInfinite Preparative iCIEF instrument system was verified by the congruent charge isomer peaks between the iCIEF separation of the NISTmAb and its input into the MS, as well as the successful identification of the individual peaks. This technique can easily be applied to other mAbs as well as other protein-based biopharmaceuticals with little additional development from the initial iCIEF method.
Characterization of high-resolution carrier ampholytes
Since its inception, iCIEF has become a key technique for analyzing protein charge heterogeneity. Carrier ampholyte quality dictates the reproducibility of the separation itself as well as the potential for downstream assays through fractionation or iCIEF-MS coupling. A lack of consistency between CA lots from a single manufacturer can introduce significant problems in the application of CIEF as a reproducible tool in the biopharmaceutical industry, particularly in quality control.
