Xuhui Analysis Co., Ltd. is located in Kunshan High-tech Zone,occupied about 1000 square meters. It has the most advanced analytical instruments such as QTRAP6500, API4000 +, API4000, and HPLC. All the instruments have passed 3Q verification.
Suzhou Xuhui Analysis Co., Ltd. was founded in 2016 by a well-known listed company in the industry [Guangzhou Boji Medical Biotechnological Co. Ltd. Stock Code: 300404] and senior experts in the field of analysis. It is a research company providing professional biological analysis services for clinical and non-clinical studies.
Xuhui Analysis is located in Kunshan High-tech Zone, Jiangsu Province, China and Germany Bio-pharmaceutical Industry Park, the existing facility area of more than 1000 square meters, the establishment of a complete quality management system for drug clinical research and laboratory management guidelines in line with the analysis of biological samples for drug clinical trials, with international standards, the first-class domestic experimental facilities. It is equipped with the world's leading analytical equipments. The laboratory is divided into 9 functional areas:standard storage room, reagent/consumable storage room, sample storage room, nitrogen chamber, central control room, archives management room, reagent configuration room, sample processing area and detection and analysis area, with API 6500 QTRAP, API 4000, Shimadzu HPLC, nitrogen generation system, Shante UPS, medical cryogenic chamber, medical treatment and analysis area. Centrifuge, medical refrigerator, ultra-low temperature refrigerator, liquid phase extraction device, solid phase extraction device, independent temperature and humidity monitoring system and other high-end equipment.
In 2017, the company won the "Made in China 2025" pilot demonstration award in the "Biological Sample Analyzing Center Platform Construction" project.
In 2018, passed the interlaboratory quality assessment of the national pharmacokinetics laboratory.
Team and main services
The company has more than 40 staff, of which more than 40% have master degree or doctor degree. The main management personnel are returnees who have been engaged in drug research and development work for many years and completed hundreds of pharmacokinetical studies. All technicians are trained in GLP regulations to provide services such as validation of bioassay methods, clinical and preclinical pharmacokinetics, bioequivalence assessment, quantification of biological samples.
Dr. Rick Li
Doctor of Pharmacology, Shanghai Institute of Pharmacology, Chinese Academy of Sciences, Dr. Li did his postdoctoral studies in University of Colorado Denver, and published more than 20 papers in the international academic publications. He has been a long-term reviewer of international analytical journals such as JCB, RCM, JBPA. Dr. Li complete a systematic pharmacokinetic study on the multi-component innovative Chinese medicine salvianolate powder injection. The drug was listed in the National Medical Insurance Basic Drug Catalogue and the National Pharmacopoeia. The sales in 2017 were 4.6 billion yuan, and he won the first prize of Shanghai Science and Technology. From 2008 to 2012, he joined BIONOVO Inc. as a senior research scientist and was responsible for the analysis of three multi-component botanical drugs. One of the new drug candidates has entered phase III, one has completed phase I, and the other has completed the preclinical IND study. The company has completed all GLP / GMP studies on candidate drugs and Dr. Li obtained GLP / GMP certification from University of Denver. From 2012 to 2015, he joined a listed large Company and served as the director of the Department of Analysis and Bioanalysis. He participated in and actively promoted the internationalization of the company. He established a analytical technology platform of GLP system that fully meets the requirements of international standards, provide international evaluation services. Leading the Department of Analysis and Biological Analysis through the National GLP inspection and passed all inspections by the National Drug Administration. Many studied drugs have successfully entered the phase I or phase II study in the United Stateor in China.
He is the general manager and laboratory leader of Xuhui Analysis Co., Ltd.
A medical doctor accredited by the ECFMG. He worked in Lexingen Pharmaceuticals and Synta Pharmaceuticals respectively during his stay in the United States. He has served as a pharmacological researcher, department manager and deputy director of R&D at various stages of technical and managerial positions. Involved in four projects of new drug research and development and IND declaration, one into the United States clinical phase III, two into phase II. In 2003, he joined Hutchison Whampoa Pharmaceutical (Shanghai) Co., Ltd. as Senior Research and Development Director of the Department of Pharmacology. He was responsible for pharmacological research and IND declaration of five projects. He organized and participated in the first new drug research and development and IND declaration in China to complete the phase II study. Since 2008, as one of the founders of Pengli Biomedical Technology (Shanghai) Co., Ltd, he built the largest international standard pre-clinical pharmacodynamics comprehensive evaluation platform in China. In 2011, he won the honor of entrepreneurship experts in Shanghai.
He is currently the chief technology consultant of Xuhui Analysis Co., Ltd.
Dr. Wang Li
Ph.D. from Wuhan University. She was a researcher in the Center for Metabolic Diseases of Tongji Hospital, director of research and development of Wuhan Ben Yao Kanghua. Rich experience in molecular biology and metabolic disease fields.
She is currently the R & D director of Xuhui Analysis Co., Ltd.
Dr. Cha Ruopeng
Doctor of Pathobiology, Fudan University (Shanghai Cancer Institute). He worked in Shanghai Institute of Pharmaceutical Sciences, Chinese Academy of Sciences, and was the special subject manager of Shanghai Wise Chemistry Research Co., Ltd.
Currently Deputy General Manager of Xuhui Analysis Co., Ltd.
Existing analytical method (part)
① Professional technical team
The project consists of a number of professionals with 5-15 years of experience in charge of biological sample analysis. The experimental technicians have undergone rigorous operational training and assessment.
② Improve the accuracy and precision by optimizing the method and processing, with a high internal critera.
③ Strict GLP standards control process; independent QAU department management.
④ Cooperate with clinical CRO strategy, one-stop service for pharmaceutical companies, participate in clinical program design, blood sample collection and transportation, testing and statistics.