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Updated: Jul 24, 2025

A Workflow for Lipid Nanoparticle LNP Formulation Optimization using Designed Mixture-Process Experiments and Self-Validated Ensemble Models SVEM
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A Workflow for Lipid Nanoparticle LNP Formulation Optimization using Designed Mixture-Process Experiments and Self-Validated Ensemble Models SVEM

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Optimization and Validation of a Liquid Formulation for a New Recombinant Veterinary Product using QbD Approach

María Celeste Rodríguez1, Javier Villarraza1, María Belén Tardivo2

  • 1UNL, CONICET, FBCB (School of Biochemistry and Biological Sciences), CBL (Biotechnological Center of Litoral), Cell Culture Laboratory, Ciudad Universitaria, Ruta Nacional 168 - Km 472.4 - C.C. 242 - (S3000ZAA) Santa Fe, Argentina.

Journal of Pharmaceutical Sciences
|July 8, 2023
PubMed
Summary

This study validates a new assay for recombinant equine chorionic gonadotropin (reCG) and optimizes its liquid formulation using Quality by Design (QbD) and Design of Experiments (DoE). This work establishes the first liquid formulation for eCG, improving protein drug development.

Keywords:
CQADoELiquid formulationQuality by designreCG

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