SHANGHAI XIHUA SCIENTIFIC CO., Ltd.

One-stop shop for drug late phase development;China/US operations and submission;50,000 SQ/FT FACILITY WITH 180 EMPLOYEES IN SHANGHAI


Platform

25 sets of LC/MS (API 6500plus, API5000, API 4000) ;Flow cytometry;Luminex, MSD, ELISA plate readers;Coagulometer, SPR;Automation Liquid Handlers;Watson LIMS


Service Items

Bioanalytical Service for Small Molecule Drug;Bioanalytical service to support preclinical and clinical studies;Over 400 generic drug methods;Method development/transfer and validation;Preclinical and clinical samples analysis;PK statistics and report writing;Clinical samples collection kit preparation and labeling


Bioanalytical Service for Biological Drugs and Biomarkers;Bioanalytical service to support preclinical and clinical studies;Method development and validation for biosimilars and innovative drugs;PK and PD (biomarkers) analysis for biological drug;Immunogenicity assessment (ADA and Nab);Capability for cell based Nab assay development and validation;Protein analysis reagent labeling