>>Safety Evaluation Center
安評中心

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Hubei Topgene Biological Science and Technology Co., Ltd. Wuhan branch

     Founded in November 2015, Hubei Topgene Biological Science and Technology Co., Ltd. Wuhan branch has a registered capital of RMB 10 million and around 40 employees, among which 30% hold a master's degree or above, 20% have senior titles, and 10% have middle titles. A GLP laboratory covering 8,500㎡ has already been established by the company, which is managed as per GLP norms of OECD,FDA and CFDA. Strictly acting in accordance with the international laboratory animal welfare standards of AAALAC, the company strives to improve it into a domestically leading and internationally first-class institution for preclinical safety assessment with professional, modernized and internationalized construction standards and provides all its customers with accurate and reliable technological services, including safety assessment services (core), pharmacological, toxicological, pharmacokinetics, toxicokinetics and biological analysis.
     In the coming years, Topgene will work to make itself one of the most influential and professional CRO                   enterprises in China by offering one-stop services including drug R&D, preclinical safety assessment, clinical experiments and registration of new drugs.


榮譽資質

組織機構圖

             

Equipment and facilities

     The laboratory of the company has advanced and complete instruments and equipment and the instruments are selected with international first-class and well-known brands, such as analysis instruments: Thermo LC-MS/MS liquid chromatography-mass spectrometry HPLC; Clinical examination instruments: AB flow cytometer, SYSMEX automatic biochemical analyzer, SYSMEX automatic 5 classification blood analyzer, SYSMEX automatic coagulation analyzer, Medica Easylyte K/Na/Cl electrolyte analyzer, CLINITEK automatic urine analyzer;Histopathological instruments: Olympus BX43/53 biological microscopy, multiple viewing microscopes; Safety pharmacology: DSI implantation telemetry system; Reproductive lab :TOX IVOS automatic sperm analyzer.

    The breeding and observation rooms cover an area of 3,000㎡, including 800㎡ of SPF laboratory barrier system for rodents, 200㎡ of ordinary-level experimental and observation room for rodents, 1,000㎡ of ordinary-level experimental and observation room for non-rodents Beagles, and 1,000㎡ of ordinary-level experimental and observation room for non-primates. The animals bred contain rats, mice, guinea pigs, domestic rabbit, Beagles and non-primates. The laboratory animal cages are all made according to the EU standard. The environment enrichment products are adequate. According to the Regulations for the Administration of Affairs Concerning Experimental Animals (Chinese regulation) and The Guide for the Care and Use of Laboratory Animals (American guide), IACUC are responsible for monitoring the use and feeding of animals, regular inspections, process standardization, employee training so as to guarantee professional operation and the best animal welfare.

  
Technical team

Jihong Li  Institution Chief

The second-grade professor receiving the State Council Special Allowance, he has been engaged in pharmacology and toxicology for more than 40 years. With a master's degree in biochemistry from Wuhan University, he is a second-grade professor and enjoys State Council Special Allowance. He was one of the first pharmacological toxicology experts engaged in drug safety evaluation, with more than 20 years of professional and managerial experience. He is now the general manager of Wuhan branch of Hubei Topgene biological technology co., LTD., and the chief of GLP institution.
Scientific research achievements: 1. The project of potassium diclofenac ingredients and tablets was awarded the third prize of Hubei Science and Technology Progress Award in 2000; 2., The project of isoniazid rifampicin and pyrazinamide tablets and rifampicin and isonizid tablets was awarded the third prize of Hubei Science and Technology Progress Award in 2004; 3. The project of fenofibrate chewable tablets was awarded the third prize of Hubei Science and Technology Progress Award in 2005.
Honors Member of the third session of professional committee for drug toxicology and safety evaluation of Chinese society of toxicology, member of drug toxicology committee of Chinese pharmacology society, expert of Hubei new drug evaluation expert database, expert of Hubei bureau of foreign experts affairs, executive director of Hubei toxicology society, director of Hubei and Wuhan pharmacological society, Shanghai science and technology award and evaluation expert, Zhejiang science and technology award evaluation expert, Jiangxi science and technology award evaluation expert.

Pan Jingyuan, director and researcher of QAU

She graduated from Tongji Medical College of Huazhong University of Science azlnd Technology, and has been engaged in pharmacology and toxicology for more than 40 years. 10 years of QA management experience. The first batch of experts engaged in GLP work in China.

Scientific research achievements:  Pefloxacin Mesylate Injection won the third prize of Hubei Science and Technology Progress Award in 2000, Lomefloxacin Hydrochloride and its tablets and capsules in 2000, Hubei Science and Technology Progress Award third prize in 2004, Cetirizine Hydrochloride raw materials and preparations won the second prize of Hubei Science and Technology Progress Award, and Longdan Xiegan Capsule in 2005. The second prize of Hubei Science and Technology Progress Award, the second prize of Hubei Science and Technology Progress Award for Apomorphine Hydrochloride in 2009, Ganciclovir Sodium Lactate Injection and its preparation method, patent number: CN1726917

Honors:  Member of China Toxicology Research Quality Assurance Professional Committee, Expert Bank of Hubei New Drug Review, Expert Bank of Hubei Purification Engineering, Expert Bank of Hubei Science and Technology Award Review, Expert of Wuhan Science and Technology Award Review, Expert of Shanghai Science and Technology Award Review, Expert of Zhejiang Science and Technology Award Review Expert, Jiangxi science and technology award evaluation expert.




Cui Yanjun, 

Director of Pathology, Master of Pathology, Capital Medical University,assistant researcher, 

engaged in toxic pathology diagnosis for more than 10 years, member of China Toxicology Society, member of China Society of Animal Husbandry and Veterinary Pathology, won the qualification certification of China Veterinary Pathologist in 2012. Up to now, more than 400 special pathological examinations have been undertaken, covering chemical, traditional Chinese medicine and biological products. Participated in the interlaboratory comparison of toxic pathological laboratory in 2015 and 2016, and the results were excellent. In 2017, he became director of the Hubei society of toxicology. He has received nearly 20 training sessions organized by the Society of Toxicological Pathology and Toxicology, and published many scientific papers and conference papers. Participated in the project of "Establishment and Application of Innovative Research System for Fetal Diseases" and won the 2008 Hubei Science and Technology Progress Award. Participated in the sub-project of "Establishing and Improving Experimental Reproductive and Developmental Toxicology System of Monkeys and Promoting Its Application" sponsored by the National Natural Science Foundation of China in 2018.



Tian yichao

Study Director

Master, research direction for the new drug pre-clinical safety evaluation and pharmacokinetics research, assistant researcher, member of the China Toxicology Society, director of the Hubei Experimental Animal Society. Engaged in years of pre-clinical safety evaluation of new drugs. As SD, he has undertaken more than 200 research topics. Covers traditional Chinese medicine(including single and repeated administration toxicity tests in rats before breast milk), chemical drugs(including Class I chemical drugs), biological products(including polypeptides, cells, viruses, antibodies), and a number of new drugs undertaken. Has obtained new drug clinical approval. Presided over the development of a special competitive project "Drug Toxicology Technology Platform Construction" by the Hubei Provincial Department of Science and Technology in 2016, and passed the expert review of the Provincial Department of Science and Technology. Participated in more than 10 meetings of the Chinese Toxicology Society and SD advanced training courses. He has published more than 10 papers in academic journals at home and abroad.
Articles published in professional core journals in the past five years:
[ 1] Tianyichao, Cuiyanjun, Lijihong, etc.. Safety toxicology evaluation of human umbilical cord mesenchymal stem cells[ J] .. Chinese Journal of New Drugs, 2018. Note: The appointment has been confirmed, and the study was awarded the third prize for outstanding thesis by the second academic exchange of experimental animals and toxicology in Hubei Province(2018).
[ 2] Tianyichao, Caixuezhou, Lijihong, etc.. Experimental study on the long-term toxicity of Zhichi granule to rats[ J] .. Journal of Drug Evaluation Research, 2018. Note: Recruitment confirmed.
[ 3] Tianyichao, Zhoujing, Xulingyun.. Effects of Ginkgolide B Injection on CYP1A2 Activity of Liver Microsomes in Rats in vitro[ J] .. Chinese Journal of Clinical Pharmacology, 2014, 30(3): 41-44.
[ 4] Tianyichao, Zang Cheng, Xulingyun, etc.. Effects of Ginkgolide B Injection on CYPase Activity in Rats[ J] .. Chinese Journal of New Drugs, 2013, 22(18): 73-76.


Tang siwen

Study Director

Engineer graduated from Chengdu University of Traditional Chinese Medicine in 2004 with a master's degree in pharmacology and a member of Chinese Toxicology. He has been engaged in pharmacology and toxicology for 14 years. His research direction is cardiovascular pharmacology. National, provincial and Municipal Research projects, such as the 11th Five-Year Plan, National Natural Science Foundation, Beijing Science and Technology Program, and the Scientific Research Program of Hebei Administration of Traditional Chinese Medicine, etc. One of the new drugs was approved for production and marketing, the other was approved for clinical trials, and SD participated in the preparation of the GLP laboratory and was certified in 2010. It was mainly responsible for local toxicological tests, allergic tests, hemolytic tests and safety pharmacological tests. More than ten training courses have been organized by CDE and China Toxicology Society, and more than ten scientific research papers have been published.

Honor:  the mechanism of geranidin promoting osteogenic differentiation of bone marrow stromal stem cells in 2017 (No. 20173014), the third prize of the Science and Technology Award of Hebei Society of Traditional Chinese Medicine (the fifth completed person)

Yang Ying

Study Director

pharmacy. She has been engaged in the research of pharmacology and toxicology of new drugs for more than 10 years, has completed more than 50 scientific research subjects such as traditional Chinese medicine, chemical drugs and biological agents, has published many related scientific papers, has completed more than 100 Beagle dogs'tracheal intubation, carotid femoral artery intubation, Beagle dogs' implantation and animal organ transplantation, and is now mainly responsible for cardiovascular system. Safety pharmacology of the respiratory system and central nervous system.


Yang Xu,

Study Director

Graduated from China Pharmaceutical University, graduate student, member of China Toxicology, engaged in biopharmaceuticals, pharmaceuticals, traditional Chinese medicine pharmacology and toxicology work for seven years, the research direction: pharmacokinetics, toxicokinetics, bioequivalence, test analysis. Responsible for 2 items of pharmacokinetic studies of 1.1 new drugs, responsible for 20 items of toxicokinetic studies of toxicity test, attended many pharmacokinetic conferences and various training courses organized by the Chinese Toxicology Society, and made conference reports, published 1 SCI, 2 Chinese core journals, more than 10 conference papers, and obtained 1 excellent paper.


Mao shanshan

Study Director

Graduated from guangdong pharmaceutical university, master of traditional Chinese medicine. Pharmacology and toxicology research work for many years engaged in new drugs, Chinese medicine, chemical medicine, biological agents, such as more than 10 scientific research subject, published many related research papers, many times to participate in all kinds of training course, the Chinese society of toxicology, is mainly responsible for fertility and early embryonic developmental toxicity experiment (I), embryo, embryo seed developmental toxicity experiment (II), bone marrow micro nuclear test, perinatal toxicity experiment, rats in vitro mammalian cell chromosome aberration test, bacteria back mutation experiment, mouse lymphoma, etc.


Yang Yun
Head of animal husbandry management department, Clinical veterinarian

Master's degree in veterinary medicine, nanjing agricultural university. Responsible for the company's international AAALAC certification. Member of China experimental animal society, attended many meetings of experimental animal society and training courses for non-human primates. Rich experience in animal breeding and management. Now mainly responsible for animal husbandry management and veterinary work.