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| 3D Structure |
Three dimensional reconstruction imaging of nanoscale structures using tomography or single particle averaging (SPA) methods. |
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| Applications |
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Drug Development: Support for pharmaceutical and biotechnology process development and formulation development and scale-up functions related to chemistry, manufacturing, and control (CMC). |
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Regulatory Review: Support for demonstrating that procedures are developed to ensure stability, batch-to-batch uniformity, and overall quality for IND and NDA submissions. |
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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. |
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