Service introduction

Small Molecule Bioanalysis

The business of chemical bioanalysis was officially launched in 2015, and the company has more than 50 chemical bioanalysis experts, among which more than 40% of the employees have more than 5 years of experience in GLP chemical bioanalysis. The company has established good cooperative relations with more than 300 enterprises at home and abroad, and carries out business in many countries around the world. With the entity operation in China and the United States, the company can support the bioanalysis business in China and abroad with high efficiency and quality. As of June 30, 2022, Xihua has more than 330 chemical biological analysis methods with independent intellectual property rights.
The department of chemical and pharmaceutical Bioanalysis has 5 staff with more than 10 years of experience in small molecule bioanalysis, all from well-known domestic and international CRO or pharmaceutical companies. 8 project leaders with more than 5 years of work experience. In addition, according to the ratio of support personnel: laboratory personnel = 1:10, Xihua has additional personnel dedicated to chemical QC, QA, sample management and equipment management, to support the efficient operation of chemical biological analysis.

Large Molecule Bioanalysis

The bioanalysis business of biological drugs, established in 2015, has a complete quality system, systematically verified instruments and electronic systems, and can provide bioanalysis services of clinical samples that meet the requirements of Chinese and Western drug application. Data as of 2022.06.30, there are more than 30 biological drug bioanalysis experts. There are 4 personnel with more than 10 years of macromolecular bioanalysis experience, all from domestic/international well-known CRO or pharmaceutical companies; 9 employees with 5 years of master's/doctor's experience and more than 8 years of undergraduate work experience; There are altogether 8 project leaders. In addition, according to the proportion of 10%, Xihua detection also equipped with special macromolecular QC, QA, sample management personnel and equipment management personnel, to support macromolecular biological analysis.
Xihua Macromolecular Bioanalysis group is mainly engaged in the biological analysis of clinical samples of mab, polyclonal antibody, ADC, fusion protein, polypeptide, gene therapy, vaccine, CAR-T, heparin, coagulation factor and other types of drugs. It can support the detection of PK, ADA, Nab (binding assay and cell assay), biomarkers, in vivo efficacy, flow cytometry, ELISPOT and other aspects of the drug. As of June 30, 2022, the company has accumulated about 370 analytical methods, including more than 40 self owned intellectual property biological drug analytical methods, completed nearly 100 clinical trial sample analysis of biological innovative drugs and biological analogues, and completed more than 70 drugs approved for listing in biological analysis projects.
With entity operations in both China and the United States, Xihua Macromolecular Bioanalysis can support both domestic and foreign bioanalysis businesses with high efficiency and quality.

Project Experience

Experimental Instruments

Small Molecule Bioanalysis

Large Molecule Bioanalysis