Therapeutic Developability Assessment
Potent Strategies for Therapeutic Developability Assessment
u
CE-SDS (reducing and non-reducing), SE-HPLC, cIEF
u
DSF/DLS, PTM analysis
u
Octet (FcRn and Fc-gamma R binding profile)
u
Sequence liability analysis
u
Poly-specificity analysis
u
Hydrophobicity assessment, forced degradation study
Manufacturability Assessment u
Potential hot spots for degradation and post- translational modification analysis;
u
Conformational, thermal stability and colloidal study by highthroughput methods including micro-DSC, DLS, and CD etc.;
u
Stability test in different conditions;
u
High concentration protein developability assessment.
Physicochemical Property Assessment Purity
Fragmentation
Aggregation
Thermal unfolding
Non-specific protein-protein interactions
Accelerated stress
Glycosylation
Serum stability
Charge heterogeneity
Solubility
Other Property Assessment u
u
Chemical modification assessment: we offer various evaluations including isomerization, oxidation, deamidation, as well as succinimide formation etc. To assess in vivo and in vitro binding behaviors.
In vivo properties assessment: we offer in vivo half-life characterization studies via serum stability/PK studies in rodent and cynomolgus monkeys.
Creative Biolabs Confidential
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