Analytical Services

CuriRx scientists can create analytical methods to support your CMC. We develop methods for drug substances and products from scratch, improve and expand existing methods, and even troubleshoot existing problems.  Our scientists therefore create methods that will generate information to eventually support the rapid testing of preclinical samples, formulation prototypes, and commercial samples. The resulting official test methods can be used by quality control laboratories to ensure the identity, purity, potency, and performance of said 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

Contact us for more information on our Analytical Services.

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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


✔ Stability Testing