Chromatographic Methods Development

This book is a comprehensive compilation of modern and cutting-edge chromatographic techniques written by pharmaceutical industry experts, academics, and vendors in the field. This book is an inclusive guide to developing all chromatographic methods

(such as liquid chromatography and gas chromatography). It covers modern techniques for developing methods using chromatographic development software, requirements for validations, discussion on orthogonality, and how to transfer methods from HPLC to UHPLC. The text introduces some newer techniques that are heavily employed by chemists analyzing proteins and RNAi, as well as novel techniques such as counter current chromatography. This book is valuable for both the novice starting out in undergraduate labs and those who are new to the pharmaceutical industry and is a useful reference for seasoned analysts.

Introduction--a lesson learned from UHPLC. Software for Chromatographic method development. Flash Chromatography Method Development. Orthonganality in Column chromatography. Unified approach to reverse phase and normal phase chromatography. Polysaccharide derived chiral stationary phases for the separation of enantiomers. Chiral chromatography: Method development. Aqueous Normal phase chromatography using Type-C silica columns. Ion Chromatography Columns. Ion chromatography--Method development. Fundamentals, properties, and applications of stationary phases for gas chromatography method development. GC method Development. Method Transfer from HPLC to UHPLC. Small Molecule Pharmaceutical impurities Test Method Validation: Precision Acceptance Criteria. Method Development Strategies for Ion Exchange Chromatography Using pH Gradient Separation for mAbs. Antibody Drug Conjugates (ADCs) and Other Complex Bio-Pharmaceuticals. Size exclusion chromatography method development for theraputic proteins. Ionic liquids and counter current chromatography: Is this the future of process purifications?

Gregory K. Webster is a senior principal research scientist at AbbVie Inc. He obtained his BS in chemistry from St. Xavier College, MS in analytical chemistry from Governors State University, and PhD in analytical chemistry from Northern Illinois University. Dr. Webster’s industrial career spans an employment history with several major pharmaceutical companies. His previous books with Jenny Stanford Publishing are Supercritical Fluid Chromatography: Advances and Applications in Pharmaceutical Analysis (2014) and Poorly Soluble Drugs: Dissolution and Drug Release (2016).

Laila Kott is senior director of CMC at Xenon, Canada. She earned her BS in chemistry from the University of Toronto, MS in chemistry from the University of Waterloo, and PhD in bioanalytical chemistry from the University of Massachusetts. Dr. Kott’s industrial experience spans from early-stage to late-stage development to post-approval commitments. She has experience working in several large pharmaceutical companies, contract analytical labs, and biotech startups. Her analytical background reflects her deep knowledge of many analytical techniques, which is echoed in her list of publications.