PAT Update from Interphex: SiPAT Standardizes Interfaces; PAT Training Planned for FDA CMC Reviewers

April 25, 2007
Right now, utilizing Process Analytical Technologies (PAT) is anything but "plug and play." Two years ago we first heard about C-PAT, spearheaded by Pfizer, which aimed to develop a standard interface for process analytical technologies (PAT).  Haven't heard much about that effort lately. But Siemens has been working on a similarly pronounced platform that aims to make some aspects of PAT implementation a bit easier for end users, its SiPAT platform.  The Netherlands' Vaccine Institute is using the platform in its research and development projects.  More on that soon. Next month, BMS director of new technology, Dr. Ron Miller and Purdue University's Professor Ken Morris will be discussing research they've conducted,  applying PAT to optimize roller compaction and granulation, as part of instruction planned for members of FDA's CMC review team.
Right now, utilizing Process Analytical Technologies (PAT) is anything but "plug and play." Two years ago we first heard about C-PAT, spearheaded by Pfizer, which aimed to develop a standard interface for process analytical technologies (PAT).  Haven't heard much about that effort lately. But Siemens has been working on a similarly pronounced platform that aims to make some aspects of PAT implementation a bit easier for end users, its SiPAT platform.  The Netherlands' Vaccine Institute is using the platform in its research and development projects.  More on that soon. Next month, BMS director of new technology, Dr. Ron Miller and Purdue University's Professor Ken Morris will be discussing research they've conducted,  applying PAT to optimize roller compaction and granulation, as part of instruction planned for members of FDA's CMC review team.
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