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Analytical methods & Characterization

Analytical methods and characterization tools are certainly one of the most critical elements during drug discovery till commercial manufacturing. All product and process related impurities must be detected and quantified during development stages.

Quality target product profile (QTPP)

Development of methods for small molecules, biologicals, large molecules and nanoparticles

Biosimilar comparability studies

Impurity identification, tracking & isolation

Method qualification & validation

Method transfers

Reference standards qualification

Stability of standards

Product characterisation

Raw material characterisation

Intact mass analysis:(MALDI-TOF and ESI-MS)

Peptide mass fingerprint :(MALDI-TOF and ESI-MS)

Peptide/protein sequencing: (ESI-MS/MS)

Characterisation of post-translational modification:(LCESI- MS/MS)

Analysis of impurities and chemical heterogeneity in Biopharmaceuticals (ESI-MS/MS)

Characterisation of disulfide linkages by chemical labelling and mass spectrometry

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