Janssen's Real Time release: Using MSPC to enhance batch release.

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Presented by

Sarah Nielsen, at Janssen and Herman He, at Thermo Fisher Scientific

About this talk

The Janssen real time release strategy will be presented. Multivariate statistical process modeling is used as a way to guide batch release (either via RTR or conventional testing). The RTR strategy uses spectroscopic release tests, skip lot testing and a surrogate model for dissolution. The surrogate dissolution model was developed with a dedicated pilot scale DOE and validated with commercially manufactured product. Multivariate raw material and process “health check” models ensure that the surrogate dissolution model is used appropriately.  RTRT provides greater manufacturing efficiency, process monitoring and allows for additional sampling when compared to a traditional release strategy. The presentation will illustrate the commercial use of this technology for a batch manufactured product within Janssen

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