Sizing and Counting
Accurately defining the size distribution of particles in a given sample is essential for characterization during pharmaceutical and biotechnology process development, formulation and production. Standard nanoparticle sizing methods such as dynamic light scattering (DLS) can be plagued by biases introduced by contaminants. NanoImaging Services has developed advanced Molecular Microscopy image analysis software for semi-automated particle sizing and contouring that provides precise, statistically determined, and accurate sample size distribution measurement for nanometer to sub-micron particles in heterogeneous and homogeneous sample solutions.
|Molecular Microscopy images of two different serotypes of Human Papilloma virus like particles before (left) and after (right) particle sizing
||Image-based particle sizing results in characteristic curves specific to serotype
Case Studies: Read more about our sizing and counting services in the "Characterization of Biopharmaceuticals: Gardisil" 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: Provide supplemental and potential critical data for demonstrating procedures to ensure stability, batch-to-batch uniformity, and overall quality for IND and NDA submissions.
Validation: Qualified evidence of established protocols and specifications for production process as well as demonstration of bioequivalence when manufacturing protocols are modified or improved.