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HPLC in Practice: A Virtual Symposium

June 23-24, 2020

HPLC in Practice: A Virtual Symposium

TUESDAY, JUNE 23RD, 11:00 AM–1:00 PM EDT

In light of the shelter-in-place situation that has caused the cancellation of numerous in-person conferences, LCGC presents an online symposium on June 23 and 24, 2020. Speakers will discuss high performance liquid chromatography (HPLC) techniques and methods, with a focus on practical implementation.

11:05 AM—Platform Method Development Approaches to Enable Speed to Clinic for Synthetic Molecules
Laura Blue, Principal Scientist, Process Development, Attribute Sciences, Amgen Inc.
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As the demands for breakthrough therapies and the competitive landscape continues to grow, the need to move molecules to the clinic more quickly is paramount. The average time from the start of preclinical studies to IND filing takes approximately five years, but new industry trends are pushing to cut this time in half. Additionally, as resources decrease and the number of molecules in the pipeline increases, the need for gains in efficiency are apparent. The number of molecules reaching first in human (FIH) studies has increased 13% each year for the past five years, but typically no additional resources have been allocated. While decreases in timeline and resources continue, the responsibility to control the quality attributes is unchanged which demand novel approaches to method development.

To meet these timeline demands and ensure quality, platform method development approaches have been developed for assessing the quality attributes of synthetic molecules. Platform method development approaches have been implemented for achiral purity, chiral purity, and residual solvent content. Based on the assessment of a set of reversed-phase columns for orthogonality, four columns have been selected for the achiral method screen in combination with mobile phases with varying pH. This workflow can be completed in 18 hours of run time and 2 hours of processing time, which has dramatically decreased the method development time for achiral impurity methods. This approach has provided suitable method conditions for 90% of the molecules assessed (n = 17). Similar to the achiral approach, a platform method screening approach has been developed for chiral method development. A series of eight columns is screened under both reversed-phase and normal-phase conditions. Furthermore, a platform GC-FID method has been implemented to cover the most common residual solvents used in synthetic processes. These platform approaches have enabled improved speed to clinic while maintaining product quality.