Biochemical analysis department focuses on quality analysis and control of biopharmaceuticals. The Department is mainly responsible for the analysis and characterization of biological drugs, the structure and function research, the establishment of batch release standards and the establishment and validation of related biochemical analysis methods.

　　Biochemical analysis department has a high-quality and reasonable scientific research team. The scientific research personnel of the Department have the professional knowledge of Biochemistry, microbiology and analytical chemistry, and have rich experience in protein purification, drug analysis, mass spectrometry and other fields, which can ensure the smooth progress of the Department's projects. At the same time, the members of the Department carried out experiments in accordance with strict and standardized management system and standard operating procedures to ensure the accuracy of experimental data.

　　ability

　　Advanced instruments and equipment

　　Agilent 1290-Q-TOF

　　Agilent 1260

　　Dionex U3000

　　Invitrogen 2-D electrophoresis system

　　Bio rad 1-D electrophoresis system

　　GE AKTA purifier 100

　　Biacore (in collaboration with universities)

　　Bruker maldi-tof-tof (cooperation with universities)

　　Analysis and characterization of biological drugs

　　Peptide coverage

　　Glycosylation identification

　　Disulfide bond localization

　　Identification of post translational modifications

　　Protein protein interaction

　　Biacore was used to study the interaction between proteins, which was mainly used in the determination of antibody affinity.

　　Qualitative analysis of proteomics mass spectrometry

　　The impurity bands of biopharmaceuticals in 2-D or 1-D SDS-PAGE electrophoresis were mainly identified by gel enzymolysis combined with MALDI-TOF.

　　Content determination of small molecular compounds

　　Determination of monosaccharide content

　　Determination of sialic acid content

　　Determination of amino acid content

　　Development and validation of biochemical analysis methodology

　　It is mainly responsible for the development and validation of quality standard methods for batch release of biopharmaceuticals, as well as the development of analytical methods of relevant departments.

　　* pat / QBD applied biopharmaceutical production

　　Pat / QBD technology is used to design the quality of biopharmaceuticals in the process of drug development and production, so as to ensure the quality controllability and safety of biopharmaceuticals.