We provide antibody-based solutions to human diseases with short development course at low cost, are based on the phage-displayed GH (Generic Human) synthetic antibody libraries designedconstructed with enabling approaches, leading to the throughput capacities to uplift the innovativenessproductivity in developing antibody therapeuticsdiagnostics. In conjunction with the core technologies, antibody bioinformatics capable of extracting knowledge from big data of human antibody repertoires is used to elucidate human antibody responsesto assist antibody library design.

In order to improve the disease-selectivitysafety of antibody drugs, we use the autologous hinge as an antibody lockuse protease substrate peptide as linker to generate pro-antibody. Only in the disease area, the overexpressed protease will restore the function of the antibody. The antibody lock can improve the safety of antibodiesthe quality of patient medications. This technology has global patents (granted in 15 countries)technology transfer experience. We believed that the universal antibody lock will bring a revolutionary breakthrough in antibody drugs.

A virus NT was performed in a biosafety level 3 laboratory to determine the titers. A SARS-CoV-2 enzyme-linked immunosorbent assay (ELISA) was designed to detect neutralizing antibodies in the serum, based on the binding affinity of SARS-CoV-2 viral protein 1viral protein 2 to antibodies. ELISA results viral protein 12, generated comparable neutralizing antibody titers. The results analyzed by spline regressiontwo-variable generalized additive model precisely reflected the real NT value. Our method can serve as a surrogate to quantify neutralizing antibody titer.

PCR, a gold-standard diagnostic method, were labor-intensive, time-consuming,costly, which restricted its application to widespread screening. Herein, this study purposes a one-potnon-washing method to rapidly detect virus by dual-SERS mechanism. COVID Antigens were captured by SERS nanoparticlesnovel SERS substrate simultaneously to achieve 6 order enhancements within 20 minutes. The dual-SERS sensors have reached a detection limit of 1 ng/ml in clinical samples for recognizing nucleocapsid & Spike proteins of COVID-19, which is comparable with PCR results.

The invention provides a glycan-masking and/or glycan-unmasking hemagglutinin, wherein the glycosylation site(s) is added on globular headremoved on stem. The glycan-masking and/or glycan-unmasking hemagglutinin may induce neutralizing antibody against influenza virus,cross-reactive protection against different virus. The invention also provides a method for manufacturing these antigens.

Ninety percent of human diseases are related to abnormal inflammation. WJM team has successfully developed a new monoclonal antibody that can inhibit a key inflammation protein. Animal experiments have accumulated more than ten disease modes, including a variety of solid tumors, fibrosis, degenerativecardiovascular diseases. This antibody is qualified as an orphan drug for the treatment of IPF. New coronary pneumonia has greatly increased the demand for pulmonary fibrosis treatment,has also become an important target for mergersacquisitions of global pharmaceutical companies.

A high-sensitivity quantitative ELISA detection system for the large HBV surface (LHBS) protein was developed. It includes monoclonal antibodies for LHBSchemiluminescent sandwich ELISA method. Clinical tests of the ELISA prodcuts have been performed in CHB cases. The LHBS detection methodsproducts have been filed for US provisional patentwill be submitted for the IVD approval.

The technology optimizes the antigen protein expression system, so that the structural protein Erns of CFSV converts insoluble proteins into soluble proteins during the production process. The breakthrough of this technology allows the antigen protein to be applied to the development of an immune attachment screening platform, as a specialized differential diagnostic reagents can distinguish between virus-infectedvaccinated pigs, which can be applied to the monitoring system of virus transmission rangevaccination

SeraParma™ COVID-19 IgM rapid test has high detection sensitivity, which can provide rapid detection of early COVID-19 infection. This SeraParma™ COVID-19 IgM rapid test can detect whether there are IgM antibodies produced in the early stage of infection (within 7 days of symptoms onset) with one drop of the specimen (serumfingertip blood) in 15 minutes by naked eyes compared with LFIA antibody rapid test. It is worth noting that the SeraParma™ COVID-19 IgM rapid test can accurately detect the patients with positive infection within 7 days of the onset of symptoms compared with LFIA.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infected human cell through ACE2. This study is developing a Pd nano-thin film electrode for electrochemical impedance spectroscopy. This invention can quantify neutralize antibody too. The detection platform can be used to screen 1 microliter anti-virus infection drug sample within 21 mins. Compare to SPR standard, our invention only needs 1/10000 concentration of ACE2reaction volume is ~1/30 than SPR. This invention can be adapted in detection of cancer markers,other emergency infection diseasestherapeutic drugs, too.