CuriLytics®
Led by CuriRx’s team of industry experts and state-of-the-art
high-resolution Orbitrap mass spectrometry instrumentation,
our one-of-a-kind CuriLytics® platform provides support
to CMC testing and characterization for small and large molecules
CuriLytics® capabilities:
High Resolution Mass Spectrometry
Orthogonal Approach
Discovery and Targeted Proteomics
Structural Characterization
Purity/Product Related Impurities
Physiochemical Properties
Process Related Impurities
CuriRx can help you solve your most complex analytical challenges by designing flexible and customized programs through our CuriLytics® platform that encompasses complete characterization according to ICH Guideline Q6B, improving and de-risking the overall drug development path from Phase I clinical trials through approval requires advanced analyses of critical quality attributes. CMC evaluation of biological molecules, including antibodies, occurs at various stages of development and involves monitoring a range of critical quality attributes through peptide mapping, determination of disulfide linkages, localizing post-translational modifications, and glycan profiling.
Using high-resolution mass spectrometry and a battery of orthogonal characterization methods, CuriLytics® offers a powerful way to overcome these challenges, providing greater insight in characterization and an improved understanding of biotherapeutic drugs. CuriLytics® identifies quality attributes of protein candidates at the individual residue level, offering a detailed understanding of how changes in process or production affect a drug product.
High Resolution
Mass Spectrometry
✔ Protein, Antibody, ADC, AAV etc stability analysis
✔ HCP (host cell protein) analysis
✔ Small molecule analysis
✔ Glycan analysis
✔ Disulfide bond mapping
✔ Characterize protein conjugation
✔ Proteins identification
✔ Metabolomics
✔ mAb sequencing
✔ Label-free quantitation
CMC Support Services
✔ Protein Identification
✔ Peptide Mapping
✔ Antibody/Protein Characterization
✔ Protein Post-Translational Modifications (PTMs)
✔ Accurate Mass Measurement of Peptides, Proteins, and Small Molecules
✔ Protein Aggregation
✔ HCP (Host Cell Protein) Analysis
✔ Protein Quantitation Analysis
✔ Protein Glycosylation Analysis and Released Glycan Profiling