Early Phase Implementation of Process Analytical Technology (PAT) Tools in Chemical Development

In the pharmaceutical industry, the pressure to decrease development times for new chemical entities is common.  During the recent 17th International Process Development Conference, Terry Connelly of Pfizer discussed this particular challenge during the presentation “Examples of Early Phase Implementation of Process Analytical Technology (PAT) Tools:  Meeting Short Term Goals While Setting the Stage for Long-Term Process Understanding and Control”.

International Process Development Conference Mettler Toledo

17th International Process Development Conference

Terry discussed how the legacy Wyeth research organization developed a productivity model that required the Chemical Development organization to generate two lots of Active Pharmaceutical Ingredients (APIs) within an eight month time frame.  The successful integration of Process Analytical Technology (PAT) tools into the legacy Wyeth Chemical Development organization was critical in the ability to develop safe, scalable processes within the compressed timelines.

Within the legacy Wyeth organization, a business model was developed by the research organization with the goal of submitting two New Drug Applications (NDA) for new molecular entities each year.  As a result of the productivity model developed by the legacy Wyeth organization, the cycle time from lead selection to Phase I decreased and the number of candidates in early development increased as the Wyeth Chemical Developmment headcount remained neutral.

To respond to the increased workload without additional resources, the legacy Wyeth Chemical Development organization invested in technologies that enabled parallel reaction screening and provided Process Analytical Technology-data such as real-time in situ FTIR and heat flow profiles.  Use of these Process Analytical Technology tools led to greater process understanding and enabled transfer to the Scale-up Units with shortened development times.

The particular example Terry discussed relied on the use of real-time in situ FTIR to explore the design space around the reaction temperature for a low-temperature enolization and azidation sequence.

What tools have you used to shorten chemical development time?

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