Classroom 2, Sanderson Building
Drug product development involves various activities such as drug substance characterisation, excipient selection, formulation development, process identification, process development, scale up, process robustness, technology transfer, process validation, regulatory submission and commercialisation. All these steps involve fundamental science and Process Engineering application. Lot of techniques have been developed for material characterisation and recently tools have been developed for process modelling for critical unit operations.
In this presentation, case studies will be presented to highlight the key principles related to formulation development and application of first principles approach for process development. Drug development activities related to late phase oncology product development and some of the troubleshooting for critical process and formulation issues will be discussed in this keynote lecture.
Prof Dr Bindhumadhavan Gururajan is Senior Principal Scientist (Fellow) for Formulation and Process Development and a High Performance Pharmaceutical Development Formulation Project Leader in Novartis Pharma, Basel, Switzerland. From 2020, he is appointed as Honorary Visiting Professor at School of Engineering, University of Edinburgh (15th ranking in QS World ranking 2023). He has done his Masters in Chemical Engineering from Indian Institute of Technology Delhi and PhD in Chemical Engineering from The University of Birmingham, U.K. Later did his Post-Doctoral research in Pharmaceutical Sciences with University of Greenwich, U.K. based in Pfizer Research Center, Sandwich site on granulation process scale up and modelling. He is an Internationally recognised Pharmaceutical Granulation Expert. He has two decades of hands on practical experience in drug development and delivery by working for four major pharmaceutical company namely Merck, Pfizer, AstraZeneca and Novartis in his career. He is certified Chartered Engineer and Chartered Scientist. Fellow of Royal Society of Chemistry, Institute of Chemical Engineers and Academy of Pharmaceutical Sciences. Master Black Belt in Lean Six Sigma for quality management system.
He holds several patents for inflammation and oncology (cancer) drug product formulations and widely published in the granulation process research area. He developed the formulation and manufacturing process for two recent breast cancer product Kisqali and Piqray to improve patients life. He is currently work on late phase oncology project in particular formulation and process development by applying Chemical Engineering first principles approach. His research work is multidisciplinary covering broad spectrum of Material Sciences, Chemical Sciences, Formulation Sciences, Chemical Engineering principles and Pharmaceutical Sciences.
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