Nanomaterials are being increasingly incorporated into medical products regulated by FDA, both as complex drug products and medical devices. This presents a growing challenge to the Agency’s readiness to evaluate products containing nanomaterials. It is critical to develop the proper tools and establish new methods capable of both identifying nanomaterials and reliably assessing safety and efficacy concerns thorough characterization.<br/> <br/>Electron microscopy (EM), including transmission electron microscopy (TEM) and scanning electron microscopy (SEM), has been used for characterizing a wide variety of nanomaterials. The advantages of electron microscopy over other nanomaterial characterization techniques include direct imaging, ultra-high resolution and a broad range of magnifications, which allow it to examine morphological properties of both nanoparticles and nano/micro-structured surfaces. However, traditional sample preparation for electron microscopy often requires samples to be dried before being placed into the microscope, which inevitably deforms and alters the original structure of delicate nanomaterials, such as liposomes, emulsions, suspensions, hydrogels, polymers and many others. Cryogenic sample preparation coupled with plunge freezing, on the other hand, effectively preserves the native structure of the specimens in vitrified hydrated state thus allow for direct visualization of morphological properties in situ.<br/> <br/>In this presentation, we will provide examples on the use of cryo-EM to investigate native structure of drug and device products. The structural differences, as observed by room temperature-EM and cryo-EM, will be demonstrated.

Application of cryo-electron microscopy for morphological characterization of drug and device products

254th National Meeting (2017)

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