Lucas Lin
biomedicine
WuXi Biologics
China
Biography
Project management and team leadership (10+ members) * CMC support and functional lead * Downstream Process Characterization and Validation for phase II-III biopharmaceutical development (monoclonal antibodies / fusion proteins / enzymes) * Late phase process development and optimization: Failure Modes and Effects Analysis (FMEA), Design of Experiments (DoE), Scaled-down Models and Qualifications, Technology Transfers, Viral Clearance Studies and other BLA-enabling studies * Anti-CHO HCP ELISA kit development: DG44, CHO-K1 platforms and process-specific projects * HCP proteomics for further process understanding & improvement * Documentations: SOPs, Study Protocols & Reports, Risk Assessments, BU Work Orders * Data integrity and verifications * Trainer: English technical writing and presentation skills
Research Interest
biopharmaceutical development
