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
Photostability
Stability under acidic or basic solution
Oxidation stability
Freeze/thaw stability
Shipping stability
