Complete mAb stability characterization: From CHO cell line development to degraded polysorbate ID

Subvisible particles (SVP) in biologics are critical quality attributes that characterize a sample’s stability and quality. However, current technique’s sample requirements mean that SVP characterization only happens late in development.

In this webinar, Dr. Bernardo Cordovez, the founder and chief scientific officer of Halo Labs, will share how Aura® systems have been designed to characterize antibody stability as early as cell line development (CLD) via low volume, high-throughput subvisible particle imaging, counting, sizing, and identification. Aura® enables complete characterization from CHO CLD, developability assessment, formulation development, late-stage stability analysis, and product release.

As it is crucial to identify stable biologics candidates as early as possible, Aura® quickly assesses and screens candidates for stability and propensity for aggregation. Pairing that information followed by high-throughput formulations and screening ensures the best drug and formulations are chosen for commercialization.

Key learning objectives

• Understand high-throughput biophysical and protein aggregation characterization of biologics in CHO cell line development
• Learn how to assess for excipients such as polysorbate for ideal formulations development and potential degradation leading to product instability
• Discover complete particle characterization of protein therapies for both intrinsic and extrinsic particles

Who should attend?

• Biologics developers in early phase development trying to pick their cell line candidates
• Developers who are completing developability or formulations work for product stability
• Developers looking for protein aggregation, excipient efficacy or degradation, and other CQA
• Developers who need particle size, count, and ID in their biologics drug/therapeutic

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