CMC Strategy
Analytical Method Optimization with Fusion QbD Software: An Illustrated Case Study
Almac Group
CMC Strategy
Method optimization for a synthetic peptide and small molecule API.
Almac Sciences worked with S-Matrix to test the Fusion QbD® platform, optimizing a peptide and small molecule purity method for compliance and data integrity.
Almac Sciences worked with S-Matrix to test the Fusion QbD® platform, optimizing a peptide and small molecule purity method for compliance and data integrity.
Applying QbD to Methods
Design of experiments identifies the operable region where a method is robust.
Case Study Results
The peptide and small molecule purity methods were optimized with fewer experiments and greater confidence.
Compliance and Data Integrity
Automated workflows support traceable, reviewable results.
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