Manufacturability Assessment

Manufacturability assessment predicts the likelihood of a candidate drug to become a successful product from CMC perspective. Zencore can help investigate the manufacturability of a drug candidate to identify potential risks and provide the mitigation strategy for future process development.

Manufacturability Assessment Service
  • Post-translational Modification
    • In silico sequence analysis to identify potential post-translational modification hotspots that may affect drug development.

    • Validation and assessment to predict potential PTMs (such as isomerization, deamidation, oxidation, glycosylation, etc.) using experimental methods such as LC-MS. 

  • Physicochemical Properties
    • Titer estimation based on transient transfection

    • Molecular integrity and fragment analysis by LC-MS

    • Size homogeneity evaluation by SEC-HPLC

    • Isoelectric point determination and charge variant profiling (CEX or iCIEF)

    • Thermal stability analysis by DSF

  • Stability studies
    • Accelerated stability

    • Photo stability

    • Transportation stability

    • Stability under acidic or basic solution

    • Oxidation stability

    • Freeze/thaw stability

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