The National Engineering Laboratory of Immunodiagnostic Reagents is based on Qufu Yulong Biotechnology Co., Ltd., combined with Shanghai Yulong Biotechnology Co., Ltd., Shanghai Yulong Clinical Laboratory Center, Fudan University, Shanghai University of Technology and other units to form a "production-learning-research-use" alliance, with many academicians, industry authoritative experts and famous foreign scholars as members of the board of directors and technical committees to integrate superior resources. Construct a series of R&D platforms such as antigens and labeled antigens, antibodies and labeled antibodies, new immunodiagnostic reagents, automated instruments and software, standardization of immunodiagnostic systems, clinical application of immunodiagnostic reagents, screening of immunodiagnostic protein markers, etc. It will become an important guarantee for integrating industrial innovation resources, strengthening industrial technology supply, connecting basic research with industrial R&D, an important base for condensing and cultivating engineering technology innovation talents, and an important part of the national technological innovation system.
The main tasks of the National Engineering Laboratory of Immunodiagnostic Reagents are:
-Overcome the key problems in the core technology of the immunodiagnostic reagent industry, carry out experimental research on key technologies, develop major equipment prototypes and key components, develop industrial technology, optimize and upgrade the industrial structure, conduct strategic and forward-looking technology research and development, study industrial technical standards, cultivate innovative talents in engineering technology, popularize the application of major scientific and technological achievements, and provide technical services for the industry.
—— Focusing on the diagnosis of major diseases such as tumors, infectious diseases, cardiovascular and cerebrovascular diseases, autoimmunity and cytokines, we will carry out experimental research on the core raw materials of immunodiagnostic reagents by using technologies such as prokaryotic expression system, yeast expression system, mammalian cell expression system, hybridoma technology and phage display, and develop multi-variety, high affinity and strong specificity recombinant antigens and monoclonal antibodies.
-around the diagnosis of major diseases such as tumors, cardiovascular and cerebrovascular diseases, autoimmune diseases and infectious diseases, the screening technology of diagnostic markers based on NMR metabonomics and time-of-flight mass spectrometry is adopted to screen new diagnostic markers, especially early diagnostic markers; Using bioinformatics analysis and prediction technology, Qualcomm screening technology (multi-target protein chip screening technology, phage display technology) to quickly study and screen antigen epitopes.
-Carry out experimental research on the key technology of immunodiagnostic reagents-labeled immunoassay, and develop universal labeled immunoassay such as enzyme labeling technology and fluorescence labeling technology, and new labeled immunoassay such as genetic engineering labeling technology, element labeling technology and nanoparticle labeling technology.
—— Experimental research on key technologies of production and preservation of immunodiagnostic reagents, optimizing the formulas of spot solution, coating solution, sealing solution, protein stabilizer and protective agent, and improving the stability of products.
-Developed major automation equipment for the reaction, detection and production of immunodiagnostic reagents, including all-active immunity reaction detection instruments, sampling instruments, chip assembly lines and supporting software for production, which improved the accuracy and stability, replaced imported equipment, and realized the automation and informationization of reaction, detection and production.
-In view of the diagnostic reagents related to major diseases, such as tumors, infectious diseases, cardiovascular and cerebrovascular diseases, autoimmunity and cytokines, which are in short supply or relatively backward technology in China, new varieties of immunodiagnostic reagents are developed by using new technologies such as immunoPCR technology and enzyme-linked immunospot detection (ELISPOT), which improves the technical performance index of the products, studies and formulates large-scale production technology and quality control technology, and lays the technical foundation for independent innovation for subsequent engineering and industrial development.
Since its establishment, the National Engineering Laboratory of Immunodiagnostic Reagents has built a technical team of 70 people, including more than 20 experts with senior titles. In terms of technical platform construction, the equipment introduction, installation and debugging of seven R&D platforms have been completed, forming R&D capabilities; Development of recombinant antigen expression technology, antigen (peptide) library and antibody library technology, antigen-antibody labeling technology, immune chip technology, immunosensor technology, immune diagnosis small molecular markers screening technology.
Relying on the R&D team and technical platform, the National Engineering Laboratory of Immunodiagnostic Reagents has achieved many fruitful R&D achievements:
(1) For five major diseases, such as cardiovascular diseases, tumors, infectious diseases, autoimmune diseases and cytokines, 30 antigens, 30 pairs of antibodies, 10 labeled antigens and 20 labeled antibodies were developed, a large-capacity library of major disease antigens (peptides) and a large-capacity and diverse library of major disease detection antibodies were established, and two high-density culture products of mammalian cells were completed.
(2) The development of 9 immune kits, 2 enzyme-linked immunospot detection kits, 3 immunoPCR detection kits and 3 immune chips was completed, and the corresponding production technology and quality standards were established;
(3) The prototype, sample spotter, sample spotter and assembly line of fully active immune chip detection system were developed, and the corresponding production technology and quality standards were established.
(4) Screening 8 immunodiagnostic markers with clinical significance, establishing a standard clinical test scheme for immunodiagnostic reagents, and completing the development of 3 standards, controls, calibrators and quality controls;
(5) More than 100 patents were applied.