Founded in 2006, JUSBIO SCIENCES (SHANGHAI) CO.LTD is a national high-tech enterprise providing professional medical diagnostic reagents, instruments, technologies and services for hospitals and laboratories. It has obtained Class III Medical Device Manufacturing License and 55 registered products. It has been certified by the National Ministry of Industry and Information Technology as a Specialized, Refined, Innovative and New “Little Giant” Enterprise, Shanghai Science and Technology Small Giant Cultivating Enterprise, Shanghai Specialized, Refined, Innovative and New Small and Medium-sized Enterprises and other honors. JUSBIO has passed ISO13485:2016 international quality system certification, and has been awarded with Shanghai Quality System Class A Certification for 15 years.
By the innovative integration of medical institutions, research facilities and manufacturers, JUSBIO transforms the latest domestic and international scientific research results applicable to the clinics into IVD diagnostic reagents and related instruments and equipment, and serves major medical institutions in China.
Milestones
VENUE & QUALIFICATION
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The new production base of JUSBIO is located in Building 8 of Lingang Songjiang Science and Technology Park, covering an area of 12,000m², integrating R&D, production, warehousing, quality control and office functions. The interior of the plant is equipped with specialized purified water preparation system, industrial-grade vacuum lyophilizer, automated filling production line equipment , disposable dispensing system, etc. At the same time, there is an independent 100,000 class purified overalls clean room and high pressure pulsed steam sterilizer, etc., which provide protection for the daily production of the kits.
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Purified Water Preparation System
JUSBIO has equipped an advanced purified water preparation system in an independent area. The raw water undergoes multi-stage pre-treatment, and is sequentially treated by double-stage reverse osmosis process, continuous electrodesalination (EDI) process, ultraviolet disinfection process, mixed bed process, and finally gets the water for the production process, which can meet the requirements of pharmaceutical-grade water quality. -
Industrial Freeze Dryer
It is used for freeze-drying of biochemical calibration products with freeze-drying area up to 1m², and the efficiency can reach the international advanced level. -
Disposable Dispensing Systems
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Fully Automatic Multi-specification Filling and Labeling Production Line
Bottle, cap, canning, capping, loading detection, labeling - automatic high-speed production line, one machine to realize a variety of different amounts of reagents canning, labeling. With magnetic bead stirring and mixing system, the speed of the whole machine is 40-70 bottles/minute, canning accuracy ±1-2%, labeling speed ≥120 bottles/minute, with intelligent label recognition function. -
Class 100,000 Purified Work Clothes Clean Room
Jusbio has an independent Class 100,000 cleanroom. The internal configuration of professional laundry, drying machines, laminar flow dressing and other equipment for cleaning drying, and finishing of cleanroom garments, to support production of assay kit. -
Pulsed Autoclave
Honors and Qualifications
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Business License
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Medical Device Manufacturing License
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EN ISO13485:2016 Quality Management System Certification
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2021 Shanghai High-tech Enterprises (Municipal)
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2021 Shanghai “Specialized, Refined, Innovative and New”Small and Medium-sized Enterprises
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2022 Shanghai Science and Technology Small Giant Cultivating Enterprises
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2022 National Ministry of Industry and Information Technology-Specialized, Refined, Innovative and New "Little Giant” Enterprises (National Level)
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2022 Songjiang District Enterprise Technology Center Certification (District Level)
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2023 Top 100 Private Enterprises Driven by Science and Innovation in the G60 Science and Innovation Corridor of Yangtze River Delta (Jiuting Town)
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CNAS LABORATORY ACCREDITATION CERTIFICATE
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Science and Technology Program
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Development and industrialization of plasma microRNA-based nucleic acid diagnostic kits for hepatocellular carcinoma markers, a sub-theme of the National 12th Five-Year Plan-2013 Major National Science and Technology Projects "Prevention and Treatment of Major Infectious Diseases such as HIV/AIDS and Viral Hepatitis" (No. 2013ZX10002007).
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Establishing a new miRNA-CTC-ctDNA tumor liquid biopsy technology integrating artificial intelligence and a standardized testing platform for the whole chain of liquid biopsy of tumors, as a sub-topic of "Research on the development and evaluation of liquid biopsy-based screening and early diagnosis of common malignant tumors" (Topic No. 2019YFC1315800) of the Key Research and Development Program of the Ministry of Science and Technology of the People's Republic of China in 2019 (Key Special Project on the Research on Prevention and Control of Major Chronic Non-Communicable Diseases)
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Biomedical Support Project Science and Technology Commission of Shanghai Municipality (STCSM) Project Name: "Development of Fully Automated Detection and Analysis System for Circulating Tumor Cells" (Project No. 16441901900)
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High-tech Industrialization (Biomedical Field) Project Name: "R&D and Industrialization of Cancer Diagnostic Reagents Based on Micro RNA Molecular Detection Platform", Advanced Manufacturing Industry Supporting Project, Minhang District Economic Commission, FY2019
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Shanghai Health and Sanitation Commission Collaborative Innovation Cluster Project - Research on molecular medicine and application of precision intervention for major tumors Project name: "Research and development of new technologies for diagnosis and treatment of malignant tumors of the digestive system and research on the application of precision intervention" (Project No. 2019CXJQ02)
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Science and Technology Commission of Shanghai Municipality (STCSM) 2021 " Technology and Innovation Cooperation Action Plan " Biomedical Science and Technology Support Special Project Project Name: "Development and Application of Circulating Tumor Cell Detection Reagents" (Project No. 22S31906600)
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Science and Technology Commission of Shanghai Municipality (STCSM) 2023 " Technology and Innovation Cooperation Action Plan " Biomedical Science and Technology Support Special Project Project Name: Human Multi-Gene Mutation Detection System Development and Application" (Project No. 23S1902400)
