431023 Can R&D be Standardized? Implementation of a Recipe Framework Supporting Lab to Patient Execution and Analytics

Friday, November 13, 2015: 8:30 AM
Ballroom B (Salt Palace Convention Center)
Alison Harkins1, Paul McCarthy2 and Emmett O'Connor2, (1)PDMS, Janssen Pharmaceuticals, Malvern, PA, (2)TQS Integration, Lismore, Ireland

The benefits of a recipe framework have been recognized in manufacturing organizations for several years, but implementation in a development environment brings different challenges – and measurable benefits to drive appropriate scientific and engineering knowledge.  To accomplish this task in a development environment a significant amount of structure needs to be implemented in the underlying laboratory systems, ensuring data can be captured with appropriate context.  In this presentation, we will outline how we are implementing a flexible S88 recipe model across the organization to enable process definition, drive execution with context, and provide visualization of experiments/batches to compare this contextualized data across sites and scales.  Detailed examples of the approach, resulting analysis tools, and challenges encountered, will be provided.  This presentation will also outline how this framework can help a research and development organization easily analyze scale up and manufacturing processes, and enable transfer of process knowledge through development and commercialization.

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