The lab is equipped with state-of-the-art bio-analytical instruments and PK analysis & simulation software. It offers preclinical PK and TK study design for new chemical drugs, bio-therapeutic products, natural medicines and special preparations, as well as analysis services for in vivo drug concentration and anti-drug antibody. It is NMPA and OECD-GLP accredited, and has successfully passed FDA inspection. To solve the technical bottlenecks affecting the preclinical PK and TK analysis of biological samples in China, the lab has established a number of new technologies and methods, mastered the key technologies of preclinical study of bio-therapeutic products, and built an intensively integrated, high-throughput and large-scale testing platform.
Established a highly sensitive and specific innovative TK testing platform for small molecule drugs based on UPLC-MS/MS, and acquired high-throughput, high-precision, high-efficiency, automated and microscale research and technical service capabilities for chemical drugs and biological agents (small molecule target drugs: such as small peptides and nucleic acid). The lab is equipped with a daily testing capability of 2500 GLP samples, supporting the rapid commercialization of innovative drug research. All bio-analysts have extensive experience in small molecule (including chiral compounds) and peptide analysis, and have mastered the relevant regulations for bioanalysis. More than 100 drugs are analyzed each year.
Instruments and Information System
|Analysis of Antibody Drug and Gene Therapy Drug
Established in vivo detection technologies for antibody drugs, gene therapy drugs and cell therapy in line with international standards, and equipped with the facility scale and technological capability for multiple in vivo drug concentration analyses and detections.