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EP34431
Poster Title: Efficient Identification and Management of Degradant Data in Process Development
Submitted on 05 Nov 2020
Author(s): Andrew Anderson, Sanjivanjit K. Bhal, Joe DiMartino
Affiliations: Advanced Chemistry Development, Inc. (ACD/Labs), 8 King Street East, Toronto, ON, M5C 1B5, Canada
Poster Views: 224
Submitted on 05 Nov 2020
Author(s): Andrew Anderson, Sanjivanjit K. Bhal, Joe DiMartino
Affiliations: Advanced Chemistry Development, Inc. (ACD/Labs), 8 King Street East, Toronto, ON, M5C 1B5, Canada
Poster Views: 224
Abstract: Here we will discuss Luminata™, a software solution that captures structural, analytical, and process-related data in a structured and searchable manner to facilitate productive inter- and intradepartmental communications. In this case, focusing on the capability of storing forced degradation data and metadata, to help build stability indicating methods.Summary: Large quantities of data are generated in route development for an API. While scientists have designed processes to document and understand forced degradants associated with the API, this knowledge is still disconnected from experimental sources and often distributed across a variety of systems.References: ACD/Labs would like to thank Valter Russo, Director, Zirkon Ltd.
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