Performance by Design Approach to Method Development
Dr. Oscar Lui
Schering-Plough
Abstract
This presentation will discuss a performance by design systematic approach to
chromatographic method development. In this approach, LC method life cycle is divided into the following steps: (1) Define method/measurement requirement and review knowledge; (2) Investigate sample preparation and detection methods; (3) Investigate mobile phase (pH and organic solvents); (4) Investigate columns, temperature, gradients (organic solvent); and (5) Data analysis and modeling; (6) Further understanding and optimization; (7) Characterization and validation; (8) Continual Improvement.
The general steps are quite universal among the industry. However, the criteria applied to each step may differ from one chromatographer to another. e.g., the mobile pH selection criteria we employed are different from others. While most published work emphasized selectivity (based line separation) we do not consider the resolution factor as a criterion. We also emphasize the importance of developing multiple (orthogonal) impurity methods.
This will be a high level overview aiming to inspire discussion.
Bio.
Dr. Oscar Liu is currently a Senior Principal Scientist in the department of Oral and Specialty Product Development, Schering-Plough Research Institute (SPRI), Summit, NJ where his primary focus is on inhalation product development. He also leads SPRI Global Analytical QbD team. Prior to joining Schering-Plough in February 2007, Oscar spent two years at Par Pharmaceutical in Spring Valley, NY where he led a team developing generic pharmaceuticals.
Oscar joined Pfizer Analytical Research and Development department in Groton, CT in 1998 after receiving his Ph.D. degree from Duke University where he studied macromolecule separation by reversed-phase liquid chromatography under the guidance of Professor Charles Lochmüller. He received M.S. degree in Chemistry from SUNY-Binghamton where he studied protein and drug separation by capillary electrophoresis under the direction of Dr. Richard Hartwick. Oscar received his B.S. degree in Chemistry from Xiamen University.
Oscar serves as a Reviewer for the National Science Foundation and scientific journals; Member of Governing Board of Eastern Analytical Symposium; Member of Board of Director, Youth Orchestra of Essex County, Maplewood, NJ.
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