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Pre-Clinical Development
In vitro Biology

Our in vitro biology platform is designed to evaluate the biological properties and the mechanism of actions (MOA) of our iTAb drug candidates. These systems include further target validation, TAA/TSA binding, down-stream signal pathway characterization, T cell activation and proliferation, target killing, and more.

In vivo Biology

The in vivo biology platform evaluates the pharmacological properties, PK/PD correlation, and in vivo delivery of iTAb candidates. A wide range of humanized animal model (NOG) and PDX tumor models are established to evaluate the efficacies of iTAbs in both hematological and non-hematological tumor settings. This includes Raji, Daudi, Reh, SW480, H1975, AcPC-1, N87, and SK-OV3.

Bioanalytical

We developed and validated bioanalytical methods to support iTAb drug development. These methods include ELISA, ECL, and SIMOA. The measurement of the super-potent iTAb molecules requires extremely sensitive assays that can quantitate iTAb concentrations at pg/mL. These methods are applied to pharmacokinetics, drug metabolism and distribution, PK/PD correlation studies, and toxicity studies of iTAb molecules. We have developed and validated > 50 methods applied to analysis of binding, cell-based activity assays, animal PK, PD, TK, ADA studies, and the clinical development of iTAb.

Pre-Clinical Safety

We design safety evaluation processes and protocols following NMPA/FDA guidance. We conduct GLP toxicity studies through CROs and monitor and audit the process to satisfy the regulatory compliance for each of our studies.

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