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

Contact us for more information on our CuriLytics® Services.

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