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
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201318
Bldg 6, 860 Xinyang Rd, Lin-gang Special Area, Shanghai, China
+86-21-6818 9888
201419
289 Zhengjia Rd, Lin-gang Special Area, Shanghai, China
+86-21-6818 9888
201419
Bldg 31 (F1), 356 Zhengbo Rd, Lin-gang Special Area, Shanghai, China
+86-21-68189888
201413
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