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Comprehensive And Innovative Characterization / Analytical Methods
In the FDA’s guidance for liposome drug products there is an array of requirements for essential characterizations to the liposome drug products. It is a great challenge to develop a liposome characterization package to fulfill FDA requirements for a liposome product. There are no specific commercial setups and no industrial or academic reference for some of the characterizations, such as the assay of liposome dissolution. After years of intensive development, Cureport has established a comprehensive liposome characterization package, including:
- Particle size and PDI
- Zeta potential
- Drug encapsulation %
- Drug concentration
- Lipids concentration
- Liposome dissolution
- Phase transition temperature
- Liposome stability in plasma
- Endotoxin determination
- PEG layer thickness