From cell line to final formulation: Characterizing mAb stability throughout the development pathway

Antibody-producing Chinese hamster ovary (CHO) cell lines have been long used to produce antibodies without aggregation in mind. Aura+^® is the first instrument designed to characterize antibody stability as early as cell line development (CLD). Aura+ enables low volume, high throughput subvisible particle imaging, counting, sizing, and identification. It easily handles and analyses the biologically complex cellular and protein samples present in CLD to characterize protein stability at the point of production, following release from CHO cell lines.

In this webinar, we will show how Aura+^® quickly and accurately characterizes secreted antibody stability during CHO CLD in unfiltered cell line samples, and how it uses antibody labelling that requires volumes as low as 40 µL per sample. In addition, we will discuss how the Aura+ has the capability to rapidly assess different formulation strategies and, for the first time, how it can distinguish polysorbate degradants from other protein aggregates through the application of a novel fluorescent workflow.

Key learning objectives

• Learn more about the fluorescent labelling of protein and antibody subvisible aggregates
• Discover how to identify specific protein species using immunoassays on membrane
• Learn more about high-throughput, low-volume sub-visible particle analysis of protein therapeutics
• Discover how to determine the ideal formulation of excipients in biologics, such as polysorbate, based on measuring degraded subvisible aggregates via fluorescent labelling

Who should attend?

Anyone working on antibody, biologics, or protein therapeutics, including those working on CHO cell line development for monoclonal antibody production and/or those working on formulation development for peptide, protein, or antibody products especially those containing polysorbate during the development process.

Certificate of attendance

All webinar participants can request a certificate of attendance, including a learning outcomes summary, for continuing education purposes.