NanoImaging Services--Services

Virus and Virus Like Particle Characterization

Direct determination of virus and virus like particles (VLPs) morphology (size distribution and shape), characterization for pharmaceutical and biotechnology process development and formulation functions. NanoImaging Services performs full characterization of nanoscale viral and virus like particles using advanced cryoTEM (Transmission Electron Microscopy) methods developed specifically to preserve the native biological structure.

Adenovirus preserved in vitreous ice

Human Papilloma virus like particles preserved in vitreous ice

	Morphology Characterization determination of particle shape and size distribution
	Statistical Characterization Typing of virus particles using advanced statistical analysis methods
	3D Structure in silico reconstruction of detailed 3D virus or VLP model

Particle Size Analysis

Using advanced methods developed at NanoImaging Services, particle analysis provides precise, statistically determined, and accurate sample size distribution.



Samples A and B - CryoTEM images of two preparations of Human Papilloma virus like particles	Size distribution of sample A (blue line) and B (red line)

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