T Cell Activation Assay Customized Assay Format Cell Source: PBMC, CD3+ T, CD4+ T, CD8+ T Stimulation: TA in the presence or absence of anti-CD3/28, PHA, PMA, SEB Readout: Cell proliferation (CTG/FACS), cytokine release (ELISA/Luminex) ...
The MLR assay is considered the ‘gold standard’ T cell functional assay for the test of T cell immune checkpoint inhibitors Dendritic cells co-cultured with allogeneic CD3+ T cells Readouts: IFN-γ and IL-2 production Suitable to test both antibodies and small...
Efficacy Test in CT2.WT Model Tumor Growth Survival Evaluation (Endpoint: TV > 2000mm3 Mice under combination therapy exhibited survival benefit Efficacy Test in 4T1 Resection Model Tumors were resected on D13; Half mice to observe survival;...
Mouse Clinical Trial in PDXs Objective: to evaluate drug efficacy across 17 colorectal PDXs Pre-defined Clinical Endpoints Tumor Progression A tumor volume change >73% by the end of treatement Tumor Stasis A tumor volume change between -66% and 73% by the end of...
Efficacy Study in CDXs Tumor Growth Inhibition in MV-4-11 Survival Rate in A375 Brain Inoculation Tumor Growth Inhibition in Hep3B 2.1-7 Efficacy and Biomarker Assessment in CDXs Cancer Discovery. 2018 Jul;8(7):836-849 Cell line derived allograft and xenograft models...
Our primary manufacturing facilities are located in the Fengxian Industrial Park in the greater Shanghai area. The facilities have been fully GMP operational since 2011. The highly experienced technical and plant operation teams, including project management and...
Registration starting material strategy Impurity management – fate and linkage Potential genotoxic impurity management API manufacturing and analytical information in formats appropriate for inclusion in regulatory filings (CTD Section 3.2.S.1 through 3.2.S.7) Drug...
