Introduction to the Engineering Center
The Xi 'an Engineering Research Center for Clinical In Vitro Diagnostic Reagents was established in July 2022 based on Xi 'an Jinci Nano-Biotechnology Co., Ltd. and was approved by the Xi 'an Development and Reform Commission on November 4, 2022.
The center focuses on the major demands of the national biomedicine field, takes products as the orientation, and conducts research on key raw materials, platform technologies and product development for innovative medical devices in the field of in vitro diagnostic equipment and reagents. Actively carry out relevant technology research and development and application promotion, including project application, achievement cultivation, product transformation, technical services, etc. Strengthen the connection with related basic disciplines, closely combine basic research with clinical research, continue to carry out cooperation with well-known domestic and foreign universities and hospitals, enhance exchanges, and improve the level of research and development. Meanwhile, the center strengthens cooperation with relevant enterprises and institutions, accelerates the research and development and transformation of new technologies, new methods and new products, and, in close collaboration with related enterprises, strives to speed up the industrial production of mature new products as much as possible.
The main tasks and goals of the center are aimed at the research and development direction of clinical in vitro diagnostic reagents. By integrating the major demands of industry, academia, research, medical care and application, and in accordance with the established goals, the center aims to enhance its innovation capabilities in the field of in vitro diagnostic reagent research and development.
The work achievements of the core team
The core team of the Engineering Center, relying on the platform of Xi 'an Jinci Nano Biotechnology Co., LTD., participates in the entire process of product formation, including the operation of Jinci Nano's quality management system, product research and development, production management, and quality control management. Up to now, Xi 'an Jinci Nano Biotechnology Co., Ltd. has independently completed and obtained a total of 36 registration certificates for in vitro diagnostic reagents and diagnostic analysis instruments. Among them, there are 34 registration certificates for diagnostic reagent products (3 for Class III and 31 for Class II), and 2 registration certificates for diagnostic analysis instrument products (1 for Class II and 1 for Class III).
The registration inspection for one Class III diagnostic reagent product currently under development in 2024 has been completed, and preparations for clinical trials are now underway. Two Class II in vitro diagnostic reagent products are currently in the technical review stage and are expected to obtain registration certificates in August.
Since May 2020, the team has successively carried out cooperation with many medical device manufacturing enterprises in Suzhou, Shanghai, Xi 'an, Guangzhou and other places, providing guidance on the construction of a comprehensive quality management system for these enterprises (mainly the quality management system for the production entrusted by the registrant), product design and development, clinical trials and registration approval, etc.
The content of technology transfer services provided by the engineering center
Evaluation of clinical practicality
Evaluation of similar products
Product Function Confirmation
Technical Route Design
Technical feasibility evaluation
Management Category confirmation
Standard compliance Confirmation
Registration Path Design
Chemiluminescence Platform
Enzyme-Linked Immunosorbent Assay (ELISA) Platform
Immunochromatography platform
Immune turbidimetric platform
PCR detection technology platform
Clinical significance research/Market research
Technical analysis/Project initiation
Design and Development Plan
Risk Management Analysis
Input review
Raw Material research
Research on Reaction Systems
Performance Evaluation
Instruction Manual
Product Technical Requirements
Production SOP
Output review
Process validation plan
Process Verification Report
Verify and confirm
Registration inspection
Clinical trials
Product Registration
System Assessment
Production process scale-up