1) Assess Charge Heterogeneity by cIEF (Capillary Isoelectric Focusing)
Many proteins, including therapeutic ADCs, are post-translationally modified by glycosylation and phosphorylation, or undergo deamidation and oxidation that complicate the overall charge heterogeneity of the sample. Traditional techniques may not always be adequate to characterize such variants with sufficient resolution and sensitivity. The Maurice platform has the power to separate such variants within the sample by charge, providing needed information for biopharmaceutical development characterization, lot release, and stability requirements.
2) Measure Size and Purity of a Protein Sample
It is important to have a quantitative and reproducible test methods for protein sample purity such as aggregates, degradants, and for AAV products, ratio of capsid proteins. The Maurice Capillary Electrophoresis (CE) system is a robust alternative to traditional SDS-PAGE and is a great way to go for reproducible, quantitative measurement of proteins, antibodies, and viral vectors.
3) Characterize and Compare Protein Glycosylation Between Batches
Proteins can undergo extensive glycosylation which can be difficult to characterize and compare from batch to batch, especially during process development or validation. By treating bioprocess intermediates or the final product systematically with enzymes that remove specific glycans one at a time and separating them by charge, characterization of protein glycosylation may be compared and characterized from batch to batch.
4) Analyze Many Samples Quickly with High Sensitivity
Maurice is fast and with auto sampling can be programmed for round-the-clock operation. When methods are established, samples can be analyze semi-high throughput for routine profiling of product properties. ProteinSimple technology of capillary imaging and native fluorescence also makes it possible to analyze very little of your sample, as low as 200 µg/mL for SDS-CE (size) or 0.5 µg/mL for cIEF (charge).
5) Collect 21 CFR-Compliant Data
With Maurice’s control systems and data integrity compliance with 21-CFR is a breeze. Validate methods and Maurice can be an integral part of your quality control programs.
To learn more about Avomeen’s capillary electrophoresis and wrap around services, contact us to talk with an expert.
Our expert blogger is Dr. Khanh Ngo Courtney, Avomeen’s Project Director of Biologics. She provides clients with unparalleled expertise and tactical knowledge of protein biochemistry and molecular biology. Her experience extends from R&D to analytical method development, validation, implementation, method transfer, and optimization of test methods for the cGMP setting per USP and ICH guidelines. This understanding of the entire process helps guide successful and productive collaborations across different laboratories, sites, and functions.