Protein aggregates are usually monitored throughout the production of biotherapeutic such as antibody drugs. In terms of the extensive experience in antibody research, Creative Biolabs is proud to offer our clients all-around antibody polymer analysis services with the best quality and most competitive price.
Antibody Polymer Analysis
Since the early introduction of biologic based therapeutics, the presence of antibody aggregates can compromise safety and efficacy. While a variety of analytical techniques have been used to analyze soluble aggregates, the dominant technique continues to be size-exclusion chromatography (SEC).
SEC is a powerful tool for the separation of biotherapeutics such as monoclonal antibodies (mAb), antibody drug conjugates (ADCs), biosimilars, and bi-specific mAbs. SEC is a chromatographic method that separates molecules based on their particle size. It is usually applied to large molecules or macromolecular complexes such as antibody polymers. When samples enter the column, different molecules have different elution rates. The small particles trapped into the stationary phase pore system can go through a total volume. They will elute for longer time. In contrast, larger molecules simply pass by some stationary phase pores as they are too large to enter them. Therefore, larger molecules elute through the column faster than smaller ones.
Fig.1 Schematic of a SEC column.
Why Creative Biolabs?
SEC is a standard technique for the analysis of mAbs and their aggregates. However, as in any SEC method, a thorough evaluation needs to be performed to develop an optimum separation. Pore characteristics of the SEC column need to be optimized to have a high resolution of a mAb monomer from a dimer and higher order aggregates, as well as from fragments. Creative Biolabs provides customized SEC-based analysis services for global clients. While routine SEC can be time consuming, the use of our evolutionary SEC allows method optimization in less time with a high level of efficiency and higher degree of confidence. Additionally, the use of our novel technology makes it easier and less labor intensive to systematically examine the effects of mobile phase on antibody structure and on secondary interactions. At Creative Biolabs, optimization should evaluate a number of conditions. A suggested set of experiments should evaluate:
These experiments should incorporate information on the biological activity of the certain antibody. If factors affecting the antibody biological activity are limited, PBS is the recommended starting mobile phase. Specific implementation plans may vary depending on the antibody sample. If you are interested in further details, please don’t hesitate to contact us.
For Research Use Only.
