Using PAT to accelerate and optimize the process development of solid dosage forms.



04th November 2021 | 10:00am EST | Lizbeth Martinez, Ph. D. Associate Director Data Science, Oral Pharmaceutical Development at Novartis Basel Switzerland and Emiliano Genorini, Account Manager – MicroNIR at Viavi Solutions |WATCH FOR FREE

Near-infrared spectroscopy (NIRS), as one of the major PAT tools, has attracted a lot of attention from the pharmaceutical industry. NIRS can analyze samples without previous pretreatment, therefore reducing or eliminating wet chemistry analysis. During the development of the drug product process, each unit operation brings challenges that need to be assessed in order to prevent compromising the quality of the final product. Two examples of real PAT applications are presented in this study. The first case tackles the challenges of process development in an international environment, with different locations for manufacture and traditional analytics. Showing how PAT enables a lean evaluation of the product quality, better understanding and supports process transfer. By means of in-line monitoring of the blending process, at-line content uniformity determination on a high number of tablets and by helping the troubleshooting of segregation. The second case describes in-line monitoring by NIRS for assay determination in a wet met media milling process of a nano-suspension. NIRS proved to be a versatile and valuable tool for the pharmaceutical development and manufacturing of solid dosage forms.
Presented by Lizbeth Martinez, Ph. D. Associate Director Data Science, Oral Pharmaceutical Development at Novartis Basel Switzerland 

Lizbeth Martinez holds a PhD in Pharmaceutical Technology from the University of Basel in Switzerland. Her research has been focused on the implementation of PAT tools for the real-time monitoring of pharmaceutical processes in batch and continuous modalities.  Since 2011, Lizbeth has been working for Novartis Switzerland under different expert positions related to PAT and process validation. She combines pharmaceutical process understanding with PAT tools and data science for optimization, troubleshooting and release of pharmaceutical products.
Followed by Emiliano Genorini, Account Manager – MicroNIR at Viavi Solutions

Emiliano Genorini has more than 20 years’ experience in NIR spectroscopy with deep knowledge of pharma and Ag-Food-Feed applications. He has a degree in chemistry with specialization in analytical chemistry of environmental pollutants. From 2003 to 2016 he was Adjunct Professor of Chemometrics at the University of Milano and Pavia. Emiliano is a top Account Manager at VIAVI Solutions specializing in the MicroNIR™ line of compact near-infrared (NIR) spectrometers.
Sponsored by Viavi Solutions

VIAVI Solutions designs & manufactures the MicroNIR™ family of miniaturized near infrared spectrometers. MicroNIR process instruments – wired and wireless – address the stringent requirements of Process Analytical Technology (PAT) and Quality by Design (QbD) and are designed for continuous and batch monitoring in regulated GMP environments. The PAT instruments can be adapted to multiple measurement modalities including powders, solids, emulsions, and liquids. The wireless MicroNIR OnSite-W is a rugged handheld instrument for field analysis of constituent materials and finished products. MicroNIR instruments can deliver solutions throughout the supply chain and anywhere in manufacturing processes. The Optical Security and Performance Products (OSP) business segment of VIAVI Solutions leverages its core technology strengths of optical coatings and materials to manage light and color effects to serve customers in consumer electronics, government, automotive and anti-counterfeiting markets. Learn more at: www.micronir.com


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