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Bioanalytical Services

Bioanalytical Services:

Bioanalytical Services

1. 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 100 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. Since its establishment, the company has more than 200 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.



Bioanalytical Services


2. 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. At present, 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. At present, the macromolecular Bioanalysis department of Xihua has supported the bioanalysis of more than 40 biosimilar drugs and more than 90 innovative drugs, and supported the sample analysis of more than 200 biological drugs in clinical trials. Thirteen biosimilar drugs, such as bevacizumab, denizumab, adalimumab, recombinant human coagulation factor ⅷ, heparin and other drugs, have passed the on-site inspection of the drug authority.

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.


Bioanalytical Services