Formulation Science and Process Engineering for Drug Product Development
Time: 12:00 pm - 12:30 pm
Date: 25 April 2023
Drug product development involves various activities such as drug substance characterization, excipient selection, formulation development, process identification, process development, scale up, process robustness, technology transfer, process validation, regulatory submission and commercialization. All these steps involve fundamental science and Process Engineering application. Lot of techniques have been developed for material characterization and recently tools have been… Read more »
Making PharmaceuticalsSynopsis
Drug product development involves various activities such as drug substance characterization, excipient selection, formulation development, process identification, process development, scale up, process robustness, technology transfer, process validation, regulatory submission and commercialization. All these steps involve fundamental science and Process Engineering application. Lot of techniques have been developed for material characterization 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 product development and some of the troubleshooting for critical process and formulation issues will be discussed.
Speakers
Prof Dr Bindhu Gururajan Senior Expert, Science and Technology - Novartis
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