Presented by Dr. Jinghan Su, Assistant Director and Head of Developability, and Dr. Qian Sun, Director, Head of Analytical Development and Quality Control at ChemPartner.
Abstract:
Biological macromolecules (monoclonal antibodies, recombinant proteins, fusion proteins, antibody-drug-conjugates, polypeptides and vaccines, etc.) are powerful therapeutics, and their characterization has drawn considerable attention and urgency in the biopharmaceutical industry. A developability assessment at an early stage can provide a better understanding of candidates, deliver better and safer therapeutic candidates and reduce risk during late-stage development.
- Antibody quality attributes that are critical to development and traditional and state-of-the-art analytical methods to monitor those attributes
- A practical workflow for developability assessment, including in silico evaluation, extended characterization and preliminary stability studies using appropriate analytical methods
- Case studies on conducting developability assessment experiments
