Our scientists develop, transfer, improve, and troubleshoot analytical methods for drug substances and products.
These are the steps most common to analytical development projects:
- Method development plans
- Generation of test procedures
- Methods validation/qualification protocols
- Validation/qualification test method generation
- Validation/qualification reports
- Technology transfer
CuriLytics®- CMC Analytical Support
- High Resolution Mass Spectrometry
- Orthogonal Approach
- Discovery and Targeted Proteomics
- Structural Characterization
- Purity/Product Related Impurities
- Physiochemical Properties
- Process Related Impurities
Analytical Testing Services
- Protein identification
- Peptide mapping
- Antibody/protein characterization
- Protein post-translational modifications
- Protein disulfide bond mapping
- Accurate mass measurement
- Protein aggregation
- HCP (host cell protein) analysis
- Protein quantitation analysis
- Protein glycosylation analysis
- Released glycan profiling
Quality Testing
- Quantification
- Verification
- Stability Testing