Safety Assessment Center

Wuhan Branch of Hubei Topgene Biotechnology Co., Ltd.was founded in November, 2015. The staff members with the degrees of masters and doctors and above account for 30%, and those with senior titles account for 20% and intermediate title accounts for 10%. The Company has established it GLP laboratory covering the area of 8500㎡, and is managed on the basis of GLP standards of OECD, FDA and NMPA. It follows the AAALAC international experimental animal benefit standards with all efforts made to build the preclinical safety evaluation organization that takes the lead at home and abroad with its professional, modernized and internationalized construction standards providing accurate and reliable technical services such as pharmacology, toxicology, pharmacokinetics, toxicokinetics and bioanalysis with safety evaluation services as the core for the world’s excellent pharmaceutical enterprises and drug research and development institutions. The Company provides customers with one-stop services from drug research and development, preclinical safety evaluation of new drugs to clinical trials and new drug registration, and is dedicated to becoming a highly influential CRO enterprise in China.

Major Apparatuses, Equipment and Facilities

Analytical instruments: Thermo LC-MS/MS, HPLC, etc; clinical testing instruments: AB flow cytometer, SYSMEX automatic biochemical analyzers, etc; histopathological instruments: Olympus BX43/53 biological microscopes, multi-person viewing microscopes, etc; safety pharmacology: DSI implant telemetry systems; reproductive laboratory: TOX IVOS automatic sperm analyzers, etc.

laboratory animal

The laboratory animal feeding and observation room covers an area of 3000㎡. It mainly includes 800㎡rodent SPF experimental animal barrier system, 200㎡ rodent ordinary experimental observation room, 1000㎡non rodent beagle dog ordinary experimental and observation room and 1000㎡non-human primate ordinary experimental and observation room. The types of animals include mice, rats, guinea pigs, rabbits, beagle dogs and nonhuman primates. Laboratory animal cages are all customized according to EU standards. The environment of laboratory animals is rich and the products are complete. In accordance with China's Regulations on the Administration of Experimental Animals and the Guide for the Care and Use of Laboratory Animals and other laws and regulations of the United States. The Laboratory Animal Management and Use Committee (IACUC) is responsible for supervising the use and feeding of animals, regular inspection, standardizing the process, implementing training, and ensuring professional norms and the highest level of animal welfare.