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LA JOLLA, CA, United States

It is an object of the invention to provide methods and compositions for characterizing particles in a size range from about 1 m to about 10 nm, and preferably 5 m to about 5 nm. Using transmission electron microscopy and digital image processing techniques, the methods of the present invention can provide detailed information on the aggregation state of, for example, proteinaceous samples such as antibody-based pharmaceutical compositions. The methods can further permit assessment of the effect of storage, use, processing, and shipping conditions in such proteinaceous samples.

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 223.24K | Year: 2014

DESCRIPTION (provided by applicant): Transmission electron microscopy is a valuable technique for characterizing biological therapeutics, vaccines, drug delivery vehicles, and nanoparticles. There is considerable evidence that links the physical propertiesof these samples to their bio-distribution, safety, and efficacy. TEM imaging allows direct observation and quantification of these parameters, which include size distributions, shape distributions, concentrations, aggregation states, and 2D and 3D structure determinations. This wealth of information is especially useful when researchers must troubleshoot problems of unknown origin. As bio-therapeutics and nanoparticles increase in size and complexity, TEM is becoming increasingly important as an orthogonal complement to other biophysical methods. Despite the obvious utility of TEM as a direct technique for describing the physicochemical properties of samples in a variety of relevant biological environments, the cost per sample is a significant barrier

Nanoimaging Services, Inc. | Entity website

Liposome and Emulsion Characterization Direct determination of liposomenanoparticle morphology (size distribution and shape), and assembly (lamellarity) for therapeutic lipid particles are critical tocharacterization. These factors are knownto influence biologicalactivity, biodistribution and toxicity ...

Nanoimaging Services, Inc. | Entity website

Home > Case Studies > Sub-micron Aggregate Characterization: IgG and IgM Sub-micron Aggregate Characterization: IgG and IgM The Challenge: Sub-micron Aggregate Characterization Direct determination of protein or protein complex morphology for therapeutic proteins is critical to characterization during pharmaceutical and biotechnology process development and formulation. While a myriad of techniques exist for characterization of large aggregate particulates, the analysis of sub-micron aggregates remains a challenge ...

Zhao Q.,Xiamen University | Zhao Q.,Merck And Co. | Potter C.S.,Nanoimaging Services, Inc. | Potter C.S.,Scripps Research Institute | And 10 more authors.
Human Vaccines and Immunotherapeutics | Year: 2014

Cryo-transmission electron microscopy (cryoTEM) is a powerful characterization method for assessing the structural properties of biopharmaceutical nanoparticles, including Virus Like Particle-based vaccines. We demonstrate the method using the Human Papilloma Virus (HPV) VLPs in GARDASIL®. CryoTEM, coupled to automated data collection and analysis, was used to acquire images of the particles in their hydrated state, determine their morphological characteristics, and confirm the integrity of the particles when absorbed to aluminum adjuvant. In addition, we determined the three-dimensional structure of the VLPs, both alone and when interacting with neutralizing antibodies. Two modes of binding of two different neutralizing antibodies were apparent; for HPV type 11 saturated with H11.B2, 72 potential Fab binding sites were observed at the center of each capsomer, whereas for HPV 16 interacting with H16.V5, it appears that 60 pentamers (each neighboring 6 other pentamers) bind five Fabs per pentamer, for the total of 300 potential Fab binding sites per VLP. © 2014 Landes Bioscience.

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