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Monitoring of a Chemical Reaction through PAT

Rodolfo Romanach

The monitoring of a chemical reaction through PAT was a wonderful learning exercise. The tranesterification reaction to form biodiesel was monitored through near infrared and Raman spectroscopy. It turned out that what appeared to be a simple chemical reaction (on paper), was a reaction of multiples stages. Principal Component Analysis was performed for different time periods of the reaction to better understand it. Even though this was not a reaction for a pharmaceutical process, it could provide helpful insights for future studies. The doi link for the study is: doi.org/.../12-0672

The full citation is:  Fontalvo-Gomez, M., et al., In-Line Near-Infrared (NIR) and Raman Spectroscopy Coupled with Principal Component Analysis (PCA) for In Situ Evaluation of the Transesterification Reaction. Applied Spectroscopy, 2013. 67(10): p. 1142-1149.

 

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  • I would say that the use of PAT for process understanding in Pharmaceutical R&D is fairly generalized and the benefits are well understood, especially when we are talking about flow chemistry - FTIR, NMR, HPLC are probably the most general/informative, but others can also be useful.

    When the process moves to a production setting, then the discussion on the use of PAT really needs to address all the considerations raised by Nima, and probably others. Looking at cGMP manufacturing in drug substance, the inclusion of PAT is far from being a simple yes / no decision.

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  • I would say that the use of PAT for process understanding in Pharmaceutical R&D is fairly generalized and the benefits are well understood, especially when we are talking about flow chemistry - FTIR, NMR, HPLC are probably the most general/informative, but others can also be useful.

    When the process moves to a production setting, then the discussion on the use of PAT really needs to address all the considerations raised by Nima, and probably others. Looking at cGMP manufacturing in drug substance, the inclusion of PAT is far from being a simple yes / no decision.

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