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Hangzhou Proprium Biotech Co., Ltd.
Introduction
(Hangzhou Proprium Biotech Company Limited)Located in the scenic Hangzhou Economic Development Zone, is a project dedicated to the field of biomedical product development, production and sales of high-tech enterprises. The company in October 2010 formally established with a registered capital of one thousand million dollars.
The company has in line with ISO13485 international certification standards for cleaner production laboratory of 3,000 square meters, has a world-class R & D team, the core team members named Lin Yang has published more than 90 papers on Medicine, PNAS, Science, Nature, New England J and other top journals. We have Chinese patents and two Japanese patents in liver cancer and cirrhosis of diagnostic techniques, and pending US patents and "Patent Cooperation Treaty"(PCT)。
The company has diagnostic techniques carcinoma, liver cirrhosis and a number of cardiovascular and cerebrovascular disease detection, holding completely independent intellectual property rights and on the basis of this technology successfully developed a variety of new diagnostic products, with rapid clinical and simple diagnostic characteristics . The company developed a portable diagnostic immunoassay by the manufacturing technology of the world's leading German companies on behalf of processing. The company is committed to build a detection reagent supporting innovative diagnostic instrumentation combined platform to achieve quick and easy diagnosis of cancer and cardiovascular disease.
The company strictly in accordance with ISO 13485: 2008 quality management system for production management, and pursuing a "standardized production process to ensure quality and to meet regulatory requirements; provide quality services to win customer satisfaction; improve the management level, to promote the benefits of growth," the quality policy.
The company now has more than 500 square meters of 100,000 clean experimental operating room, 10,000 clean room 50 square meters of the experimental operation, all of the experimental area are in line with new environmental standards air purification experiments. Now it has two experimental bio-security zone, intelligent gas distribution system, three gas incubator, fluorescence quantitative PCR instrument, automatic gel imaging system, biochip scanners, digital microscope, carbon dioxide incubator, anaerobic incubator, automatic tablet preparation system, a large heated refrigerator compartment, a large incubation chamber, and a number of ultra-low temperature freezer modern equipment.
The company has received Food and Drug Administration in Zhejiang (ZJFDA) issued by the «medical equipment production license», with the production of a second, three qualifications in vitro diagnostic reagents and instruments. The company strictly in accordance with ISO13485: 2008 quality management system to carry out the rapid detection kit manufacturing operations, reagent type main production include: colloidal gold rapid diagnostic kits, enzyme-linked immunosorbent assay (Elisa) rapid diagnostic kits, PCR rapid diagnosis detection kit. The company has established standard operating procedures of the production operations (SOP), with standardized production workshop, quality control room, raw material warehouse, finished products warehouse, can complete all kinds consistent with international and domestic biomedical industry standard production tasks. Currently Wang Pu biological rapid diagnostic kit production capacity to 10 million copies / year, to the domestic leading level of the same type of business.