Director, Global Quality Automation Eli Lilly , Indiana
This session presents the design, validation, and GMP implementation of an automated sample preparation workflow using a Hamilton Microlab STAR liquid handling system at Eli Lilly's Bioanalytical Center of Excellence (BACE). Driven by increasing batch release throughput demands and ergonomic risk-reduction goals, the platform automates complex multi-step serial dilution processes for 8-point dose-response curves across multiple biologic bioassay methods. Results demonstrate measurable gains in assay consistency, reduced inter-run variability, and decreased failure rates compared to manual preparation. This session offers a practical, regulatory-grounded framework for implementing and scaling liquid handling automation in a GMP quality control environment.
Learning Objectives:
Describe the regulatory and validation requirements — including CSV, data integrity, GAMP 5, and ICH Q2(R2) — for implementing liquid handling automation in a GMP bioanalytical environment.
Identify the design, method transfer, and informatics integration factors that drive improved assay consistency, reduced failure rates, and increased throughput in automated serial dilution workflows.
Apply a lifecycle-based qualification framework for scaling liquid handling automation across a regulated bioanalytical laboratory portfolio.
