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.
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.
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
Accelerated stability
Photo stability
Transportation stability
Stability under acidic or basic solution
Oxidation stability
Freeze/thaw stability
