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 and Sebastian Sowinski Key Account Manager at Sentronic |WATCH FOR FREE

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.

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.

Followed by an industry perspective presented by Sebastian Sowinski, Key Account Manager at Sentronic

Sebastian Sowinski is the Key Account Manager in the Spectroscopy business unit at Sentronic in Dresden. In this role, he is responsible for customers in the pharmaceutical industry and supporting them from the first proof-of-concept for PAT implementation to the final installation and qualification. He is also the main contact and support for the internal partners of Sentronic.

Sebastian holds a MBA and joined Sentronic in 2000. Starting in the spectroscopy business unit and  providing PAT solutions to in the pharmaceutical industry as early as 2004, he gained a comprehensive knowledge in near infrared spectroscopy and multivariate data analysis as well as in all aspects of the application of PAT in different stages of the development and processing of solid dose pharmaceuticals.

Sponsored by Sentronic

Sentronic is your partner in the optical measurement of chemical and biological values. We offer technological know-how and high-tech products combined with comprehensive services. Sentronic was founded in 1993 and the headquarter is located in the nice city of Dresden / Germany. Two business sectors are designed to provide a high degree of customer and market orientation.

The business unit Spectroscopy offers customer-specific industrial solutions with modular performance packages in the area of NIR and UV/VIS spectroscopy. As a system integrator and service provider, Sentronic concentrates on PAT solutions for pharmaceutical, chemical and food industries.

The business sector Sensors develops optical sensors on the basis of fluorescence as well as optical thin-film effects. The sensors are developed application-specific and with focus of series production. Our intent are smart optical sensors within everybody’s reach. Our current main products are diverse optical oxygen and dissolved oxygen sensors. With nearly 20 years of experience and skills in this field of optical sensors we are also the right partner for Your OEM products.

Sentronic could also be your competent partner in the measurement of chemical and biological values. Join us for a mutually successful partnership!

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