Large molecule bioanalysis business, established in 2015, has a complete quality system, systemically verified instruments and electronic systems, and can provide clinical sample bioanalysis services that meet the requirements of Chinese and Western drug application. Xihua large molecule bioanalysis Group is mainly engaged in the biological analysis of clinical samples of monoclonal antibody, polyclonal antibody, ADC, fusion protein, peptide, gene therapy, vaccine, CAR T, heparin, coagulation factor and other types of drugs. It can support the detection of PK, ADA, Nab (combination assay and cell assay), biomarkers, in vivo efficacy, flow cytometry, ELISPOT, etc. In addition, in accordance with a certain proportion, Xihua is also equipped with additional personnel dedicated to chemical QC, QA, sample management and equipment management, to support the efficient operation of macromolecular biological analysis.

The company has accumulated more than 600 analysis methods, including more than 40 biological drug analysis methods with proprietary intellectual property rights, completed over 200 biological innovative drugs and biosimilar drug clinical trial sample analysis, completed biological analysis projects have more than 70 drugs approved for market. (Data up to 2024.03.30)
Xihua large molecule bioanalysis operates in both China and the United States, and can support the business in China and abroad with high efficiency and quality.