Control Strategy and a Real Time Release Testing From a Development Line to Commercial Manufacturing


25th March 2020 | 10:00 am CET | Tom Van Den Kerkhof Scientist at Johnson & Johnson |BOOK FREE SEAT

Presented by Tom Van Den Kerkhof Scientist at Johnson & Johnson

After finishing my PhD in the field of IR and Raman spectroscopy, I started at J&J (2003) with the introduction of NIR spectroscopy in the analytical lab. Initially, the NIR model development was focused on identification of raw materials and models to verify the correct randomization of double-blind clinical studies. Gradually, NIR quantitative models were developed for replacing the more time consuming LC and KF analysis in the QC lab and using it as a PAT tool. My current task is to optimize the life cycle management strategy of NIR calibration models, to successfully implement them in the QC lab and manufacturing area, and to support regulatory submissions. Furthermore, I’m responsible to perform investigations towards new applications of the NIR technique as well as the use of other optical spectroscopy techniques to increase the QC lab efficiency or to be used to support the manufacturing process.


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