The large molecule bioanalysis platform can provide biological sample analysis services that comply with the relevant technical guidelines of NMPA, FDA, EMA, and ICH and meet the requirements of GLP specifications. The platform is based on the world's top analytical equipment, including multi-function microplate reader, HTRF microplate reader, electrochemiluminescence instrument (MSD), ultra-sensitive automatic microfluidic immunological detection system (Ella), liquid chip analysis system (Luminex), qPCR, ddPCR, flow cytometer and other test instruments, and established an advanced immunoassay platform and cell experiment platform, which can provide drugs such as peptides, fusion proteins, antibodies, ADCs, CAR-T, oncolytic virus and gene therapy etc. with clinical PK, pharmacodynamics, immunogenicity, biomarkers and other related research. The macromolecule bioanalysis platform has independently developed more than 150 sample analysis methods for different innovative drugs. This technology platform provides an evaluation basis for the application of bio-innovative and biosimilar drugs. At present, the macromolecule bioanalysis platform has successfully completed the establishment and methodology validation of the pharmacokinetics, immunogenicity, neutralizing antibodies and biomarkers of monoclonal antibodies, bispecific antibodies, peptides and other drugs, among which more than 30 approved domestic CAR-T clinical trials (about 300 in total) have been completed on this platform.
In addition, the macromolecular biological platform has also introduced the world's top analysis equipment, including multi-function microplate reader, Elispot enzyme-linked spot analyzer, liquid chip analysis system (Luminex), fluorescence quantitative PCR, first-generation sequencer, second-generation sequencer, etc. to build an advanced vaccine research service platform, which can provide clinical vaccine immunogenicity, immune level, viral load, virus typing and other related research services. The technology platform can provide an evaluation basis for the application of vaccines.
The platform can be used to support research on biosimilars, innovative drugs, cell and gene therapy, pharmacokinetics, immunogenicity, biomarkers, cytokines, humoral immunity, cellular immunity, etc. during the clinical evaluation of vaccines, providing reliable data for key test indicators in vaccine clinical evaluation. It is used in all disease fields, including tumors, autoimmune diseases, cardiovascular diseases, diabetes, neurodegenerative diseases, infectious diseases, and various rare diseases.