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Short Course - Characterization of Biopharmaceuticals

May 22, 2022 12:00pm ‐ May 22, 2022 3:00pm

Identification: 33738

The Virtual Short Course will host a live recording on 11 May 2022. All short course registrants are invited to attend this live recording and stay to ask questions to the course facilitators. The course will then be available for all registrants to view on-demand on starting on 22 May 2022. More information about the live session will be provided directly to the registered participants.

Session Chair(s):

Welcome & Introductions

May 23, 2022 8:00am ‐ May 23, 2022 8:15am

Identification: 33739

Session Chair(s):

Kasia Kozakowska-McDonnell

Keynote Session I

May 23, 2022 8:15am ‐ May 23, 2022 9:10am

Identification: 33740

Speaker(s):

Alain Beck

Cutting-Edge Multi-Level Analytical and Structural Characterization of Antibody-Based Therapeutics

May 23, 2022 8:15am ‐ May 23, 2022 9:10am

Identification: 357256 - 33740

Thirty-five years on from the FDA's approval of a first monoclonal antibody (mAb), these biologics account for nearly a fifth of the agency's new drug approvals each year. mAbs offer exquisite specificity and affinity for both secreted and cell-surface targets. Different formats of antibody can be used to mop up circulating proteins, to block signalling pathways outright, to drive the internalization and degradation of cell-surface receptors, to deliver small-molecule payloads to specific cell types, to recruit immune cells to cancer cells, and more. Whereas medicinal chemists can toil for years to find small molecules with activity against a given target, antibody discovery can take a matter of months.

Developability and comparability assessment of current and next generation of biologics such as engineered mAbs, Fc-fusion proteins, BsAbs and 3G-ADCs requires state-of-the-art analytical and structural methods. Antibody-based products Critical Quality Attributes will be discussed, and case studies will be presented based on native and ion mobility MS, Collision Induced Unfolding (CIU), multiplexed Top and Middle-Down MS, multiple fragmentation techniques, comprising high energy collisional-, electron-transfer and UV photo-dissociation (HCD, ETD and UVPD), CE-MS and quantification of trace-level HCPs by MS.