Integrated Biologics Developability Assessment

Pharmacology, PK/PD, and Exploratory Toxicity

Mouse, rat, monkey SC, IP, IV bolus, IV infusion Bio-analytical development PK/PD modeling and simulation In vitro stability in biological matrices Single dose, repeated dose, dose range finding in rats and monkeys Efficacy studies 160+ cell line xenografts and 270+...
Integrated Biologics Developability Assessment

ADC Release and Stability Testing

Our capabilities include the following assays: Antigen binding activity determination: ELISA, FACS Drug to Antibody ratio (DAR) determination: UV-Vis, LC-MS, HPLC-HIC, iCIEF, etc. Residues of free drug determination: LC-MS/MS In vitro efficacy and bioactivity...
Integrated Biologics Developability Assessment

Case Study on T-DM1 (Kadcyla)

Trastuzumab-DM1 (T-DM1; biosimilar of Kadcyla®) was synthesized and was tested in an in vitro efficacy assay employing an in vivo xenograft model. The following results demonstrate the in-house T-DM1 has comparable tumor inhibition activity and in vivo PK profiles...