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Analytical Development Capabilities and Technologies
Development of methods for process support, release, and characterization assays, including:
- Immunology-based methods such as ELISA and blotting for detection, quantitation, and purity
- Separation-based methods for identification, quantitation, and purity, including SDS PAGE, SDS CE, HPLC, CE, and LC-MS
- Characterization methods for protein quantitation or configuration, including spectrophotometric methods and fluorescence methods
- Cell-based methods for protein, viral, or adjuvant activity
- Compendial methods including pH, conductivity, osmolality, and endotoxin
Process Development Capabilities and Technologies
Process Development Capabilities for Drug Product
- Process scale-up: develop small-scale models, manufacture at scale
- Process optimization
- cGMP process development
- Formulation screening, selection & optimization
- Stability testing
- Development grade material manufacturing
- Lyophilization process development, cycle development, and optimization