The development of accurate and robust analytical methods for assay and impurity profiling of new chemical entities (NCEs) in pharmaceutical analysis is a complex task, and no single approach to method development is guaranteed to meet a satisfactory end. New drug substance HPLC methods must resolve a wide range of potential degradants and manufacturing impurities, and must be appropriately sensitive. Navigating the selection of initial conditions with consideration of a NCE’s molecular structure, as well as tuning the chromatographic stationary and mobile phases, and optimizing separation parameters, are all key to ensuring a method is appropriate for its intended use. Experience and expertise in this area varies widely among analytical staff in method development workflows, and thus a systematic approach to the process can offer the potential to streamline the development process.
This presentation will discuss an unbiased and systematic step-by-step approach for combining the latest UPLC technologies with rapid column and mobile phase screening platforms to develop analytical methods for impurity quantification in drug substance matrices. This strategy can reduce the analytical development timeline, improve knowledge and understanding of the underlying mechanisms of the separation, while affording viable, robust methods.
This webinar will:
Provide an overview of common method development pitfalls
Discuss the importance of unbiased column and mobile phase screening approaches
Discuss the timelines and milestones within the method development workflow including detection, column and mobile phase selection, gradient optimization, and tuning of instrument parameters for temperature, flow rate, and sample loading
The Cambrex Durham site is a world-leader in analytical services for drug substances and drug products at all stages of the clinical and commercial development lifecycle.
Dr. Daniel Kirschner, Senior Director, Analytical Services - Cambrex Durham
Dr. Kirschner joined Cambrex following the acquisition of Avista Pharma Solutions in January 2019 and has spent the past 10 years in various analytical roles within fast-paced CDMO and biopharmaceutical companies. Dr. Kirschner has worked in all stages of clinical development from pre-IND through to registration on small and large-molecule chemistries. Prior to joining Cambrex, Dr. Kirschner worked in method development groups at Gilead Sciences (Foster City, CA), and Nektar Therapeutics (Huntsville, AL). Dr Kirschner holds a Ph.D. in Bioanalytical Chemistry from the University of Alaska at Fairbanks.