PAT to Enable Kinetic Analysis and Modeling

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Deployment of a kinetic analysis platform to realize benefits for all levels of expertise
Detailed kinetic and mechanistic analysis for improved process understanding
Reduction in number of experiments via predictive kinetic modeling and process simulation
Efficient process optimization and characterization via parameter prediction

In this presentation, James Murray, Ph.D. discusses how standardizing kinetic analysis across Amgen's late stage portfolio has enabled efficient process optimization and characterization via improved mechanistic understanding. A key contributor to the success of this approach has been to deploy process analytical technologies (PAT) for in-situ reaction monitoring to collect continuous time course data throughout the course of each chemical reaction. Scientists then automated reaction monitoring and kinetic analysis through implementation of a templated approach based on Reaction Progress Kinetic Analysis (RPKA). This has facilitated the collection of continuous kinetic data by scientists across a range of experience levels and allowed detailed mechanistic analysis for use in predictive kinetic modeling.

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The role of PAT differs drastically when it is used for development, scale-up or production purposes. With such changing roles, changes in the number of techniques and frequency of use are also observed. In this talk, these differences are described, and examples are shown for each of the roles. The talk then focusses on lab-to-plant scale-up. How can PAT be used to verify or deny a correct scale-up and, in the latter case, help in finding out why the scale-up was not successful. The fingerprint concept is explained, as well as recent advances on how to bring PAT data from the lab into the plant to allow for a Live verification and data analysis during batch scale-up.

About the Presenter

James Murray, Ph.D

Amgen

James Murray received his Ph.D. in Organic Chemistry with Prof. Alan Spivey at Imperial College London, studying the use of atropisomeric aryl-N-oxide catalyst for site-selective phosphorylations and kinetic resolution of amines. He subsequently conducted post-doctoral research at the Scripps Research Institute in the laboratory of Prof. Donna Blackmond, focusing on kinetic and mechanistic studies of catalytic systems and physical processes for enantioenrichment. James then joined Pivotal and Commercial Synthetics at Amgen Thousand Oaks and is currently the Kinetics Platform Lead for the small molecule portfolio.

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