Characterization of protein and polysorbate aggregation in protein therapeutics
Join us for an exclusive webinar where Dikran Khachadourian, a Field Application Scientist at Halo Labs, will explore the Aura PTx, a complete protein therapeutic stability solution that enables the characterization of subvisible particle aggregates from developability assessment through product release.
Aura PTx is a high-throughput analytical instrument that images, counts, sizes, and identifies subvisible particle aggregates, a critical quality attribute and an important biologic stability parameter. It offers fast, detailed subvisible particle screening and precise quantification. Powered by fluorescence membrane microscopy (FMM), it distinguishes between various particulate impurities, including protein aggregates and degraded polysorbate particles, crucial for protein therapeutic development.
In this webinar, Khachadourian will also discuss how Aura PTx performs subvisible particle analysis for protein developability assessment, polysorbate degradant ID, and USP788 lot release assays.
Key learning objectives
- Understand the importance of testing the purity and stability of drug products to ensure efficacy and patient safety
- Master particle and product characterization as early as early-phase development using only 5 uL of sample
- Explore how fluorescence membrane microscopy (FMM) can be used to differentiate between subpopulations of particulates, such as protein aggregates, polysorbate degradants, and extrinsic contaminants
- Learn why backgrounded membrane imaging (BMI) has become an emerging technique for lot release testing and generating USP 788-compliant data
Who should attend?
- Protein therapy or biologics developers in developability, formulations, or development groups
- Anyone trying to understand protein and product stability and evaluate formulations for product stability and effectiveness
Certificate of attendance
All webinar participants can request a certificate of attendance, including a learning outcomes summary, for continuing education purposes.