Sub-micron Aggregate Characterization
Thorough characterization of sub-micron aggregates contained in drug products is increasingly important, but standard methods such as size exclusion chromatography (SEC) and dynamic light scattering (DLS) are indirect and fall short when it comes to the really small stuff. Visualization of sub-micron aggregate particulates in solution by Molecular Microscopy gives a direct measure of aggregate size, morphology, and distribution.
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Sub-micron aggregates detected after subjecting a solution of IgG/IgM to multiple freeze-thaw cycles |
- Direct Measurement
Are the actual sub-micron aggregate sizes and counts comparable to indirect measurements?
- Loss of Soluble Protein
What is the percent loss of soluble protein during aggregate formation?
Applications
Case Studies: Read more about our submicron aggregation studies in the "Characterization of Submicron Aggregates: IgG and IgM" case study.
Drug Development: Support for pharmaceutical and biotechnology formulation discovery, development and scale-up functions related to chemistry, manufacturing, and control (CMC).
Regulatory Review: Provided supplemental and potential critical data for demonstrating procedures to ensure stability, batch-to-batch uniformity, and overall quality for IND and NDA submissions have been development.
Validation: Qualified evidence 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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