NanoImaging Services--Services

Liposome and Emulsion Characterization

Direct determination of liposome specimen morphology (size distribution and shape), and assembly (lamellarity) for therapeutic lipid particles are critical to liposome characterization for pharmaceutical and biotechnology process development and formulation functions. NanoImaging Services performs full characterization of nanoscale liposome particles using advanced cryoTEM (Transmission Electron Microscopy) methods developed specifically to preserve the native fully hydrated biological structure of liposomes.

Fully hydrated lipid vesicles preserved in vitreous ice
(particle morphology and lamellarity directly observable)

	Morphology Characterization determination of particle shape and size distribution
	Particle Assembly Assessment the only method for direct visual assessment of liposome lamellarity
	3D Structure in silico reconstruction of detailed 3D liposome model

Applications
	Drug Development: Support for pharmaceutical and biotechnology process development and formulation development and scale-up functions related to chemistry, manufacturing, and control (CMC).
	Regulatory Review: Support for demonstrating that procedures are developed to ensure stability, batch-to-batch uniformity, and overall quality for IND and NDA submissions.
	Validation: Support for demonstration of established protocols and specifications for production process as well as demonstration of bioequivalence when manufacturing protocols are modified or improved.


Services