Proteins and Protein Complex Characterization
Direct visualization of proteins and protein complexes in solution can save hundreds of thousands of dollars spent in time and reagents during process development and formulation analysis. Is your formulation plagued by submicron aggregation? Are denatured proteins decreasing the shelf life of your drug? Does your protein complex of interest remain morphologically intact across different batch processes? NanoImaging Services performs full characterization of proteins and protein complexes in solution using state of the art Molecular Microscopy methods developed specifically to preserve the native structure of your sample and provide a direct measure of protein and protein complex morphology, aggregation state, and structure.
||Molecular Microscopy image of IgG and IgM
- Morphology Analysis
How clean and intact are the proteins in your formulation really?
- Particle Contents
Are your particles full or empty?
- Complex Characterization
What does your protein-adjuvant complex look like?
- Aggregation Assessment
Are your solubility issues a result of submicron aggregation?
Case Studies: "Characterization of Submicron Aggregates: IgG and IgM" and "Characterization of Biopharmaceuticals: Gardisil"
Drug Development: Support for pharmaceutical and biotechnology process development and formulation development and scale-up functions related to chemistry, manufacturing, and control (CMC).
Regulatory Review: Support for demonstrating that procedures are developed to ensure stability, batch-to-batch uniformity, and overall quality for IND and NDA submissions.
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.