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Analytical Method Optimization with Fusion QbD Software- An Illustrated Case Study

In this case study, analytical method optimization with Fusion QbD software for a synthetic peptide and small molecule API is discussed.

Released By Almac Group

To enhance the efficiency of the analytical method development process, Almac Sciences worked in collaboration with S-Matrix to test the Fusion QbD® software platform. Optimisation of a peptide and small molecule purity method was studied as part of this evaluation; overviews of these two cases are presented in this paper.

Fusion QbD® is a chromatography modeling and optimization software for the development, validation, and transfer of analytical methods. The Fusion QbD® software is based upon empirical modeling (statistical modeling); this empirical modeling approach can provide more flexibility with predictions. The software supports full compliance and data integrity in perfect alignment with all regulatory APLM (Analytical Procedure Lifecycle Management) and AQbD (Analytical Quality by Design) guidance.

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