This presentation will encompass various topics related to the identification and control of residual host cell proteins for biopharmaceutical development, including 1) method development of advanced LC-MS-based proteomics and multiomics approaches. These include the utilization of parallel accumulation-serial fragmentation combined with data-independent acquisition (diaPASEF) for high-throughput proteomics (Tsukidate T., et al., bioRxiv, 2024.02. 21.581388), as well as activity-based protein profiling (ABPP) of serine hydrolases to identify formulation excipient polysorbate degradative enzymes (PSDE), such as lipases (Li X., et al., Anal Chem. 2021;93(23):8161); and 2). disruptive control strategies for HCP expression and clearance. These strategies encompass clone selection, optimization of cell culture conditions, the impact of continuous manufacturing, and formulation tools (Tsukidate T., et al., J Pharm Sci 113 (3), 637).
Learning Objectives:
Upon completion, participant will be able to understand the importance of host cell proteins (HCPs) analysis and control, the current key gaps, challenges, and opportunities related to high-risk HCP analysis in the industry
Upon completion, participant will be able to understand and learn the current outstanding gaps, challenges, and innovation opportunities related to HCP control in the industry scale.
Upon completion, participant will be able to learn and understand multiple ways and real examples of engagements and collaborations for innovation in the industry.
