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

Presented by

Tom Van Den Kerkhof Scientist at Johnson & Johnson and Sebastian Sowinski at Sentronic

About this talk

Full title: Control Strategy and a Real Time Release Testing From a Development Line to Commercial Manufacturing Presented by Tom Van Den Kerkhof Scientist at Johnson & Johnson Followed by Sebastian Sowinski, Key Account Manager in the Spectroscopy business unit at Sentronic in Dresden Johnson & Johnson has invested in three different continuous manufacturing lines, where PAT applications are applied to determine the uniformity of the final blend and the core tablets. Two CM lines have been implemented to accomplish the high-volume demand of two commercial products, while a third CM multi-purpose line, allowing to perform wet-granulation, roller compaction or direct compression, has been implemented in the R&D facility for the development of new drug products. In this presentation, the PAT control strategy currently applied for the commercial products as well as the one applied for new products is presented. Furthermore, the use of the generated PAT data to release the final batch is presented for a direct compression commercial product. For this commercial product, the PAT analysis performed on the core tablets by NIR spectroscopy are used to replace the final product testing in the laboratory for the release testing of assay, content uniformity and dissolution.

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