Protein Aggregation: Mechanisms, Particle Formation, Advanced Characterization & Rheology

This intensive, 2-day course relates primarily to the challenges encountered in formulating high concentration Monoclonal Antibody based biotherapeutics. These include protein aggregation, formation of sub-visible particulates and generation of high viscosities leading to issues with syringability. The course will develop the fundamental understanding of protein structures and mechanisms potentially responsible for protein aggregation and formation of sub-visible particles. Advanced characterization techniques to characterize protein secondary and tertiary structural changes and subvisible particle characterization will be introduced. Additionally, advanced rheological testing methods will be discussed in the context of requirements and challenges in protein formulation viscosity measurements. These essential analytical methods will be reviewed along with some “tricks of the trade” to enhance and streamline the efficient and effective use of these methods. Practical case-study examples and an opportunity for attendees to use their newly-acquired knowledge in simulated situations will be included.