BPL established Bio-Engineering Research Institute in 2007 to improve R&D level and innovation capacity. The Bio-Engineering Research Institute successively develops platforms for antibody engineering, hybridoma/fully human antibody library sequence discovery, drug screening and CMC. Now there are department of engineering cell line construction, department of process development, department of cell fermentation, department of protein purification, department of analytical preparation, department of project management and patents and so on.
In the future, BPL will combine independent innovation and cooperative development. On one hand, BPL will invest more in research and development, improve the innovation mechanism, optimize various technology platforms and attract more talents to improve the capacity of independent R&D. On the other hand, BPL will strive to explore win-win cooperation in the fields of bio-medicine to realize the leapfrog development
Platform for New Drug Development
BPL has established an antibody engineering platform for antibody humanization, affinity maturation, Fc modification and bispecific antibody construction.
Sequence discovery is made through hybridoma preparation/antibody library screening, and drug discovery is made through biochemical testing, pharmacodynamic analysis and so on.
The Department of Pharmacology has established in vivo and in vitro drug screening platform. Target verification, in vivo and in vitro evaluation of drugs can be completed through establishing cell screening methods and animal models.
This platform has rich experiences in analyzing the physical and chemical properties of protein/antibody drugs, quality control and release testing of preclinical development. This platform is equipped with advanced facilities and able to carry out comprehensive quality analysis and test.
The CMC platform has established a competitive platform for process development and industrialization through functions such as high expression cell line construction and cell culture process, protein purification, quality control of biological product production, and concentrated feed batch processing.
Platform of production and quality
BPL has a comprehensive technology system in the field of antibody industrialization, including continuous perfusion, high-density mammalian cell suspension culture, antibody preparation technology, antibody quality research and control technology, antibody formulation and aseptic filling technology and pilot process for antibodies.
Now there are two buildings and three production lines of 1000L, 2500L and 4000L in BPL, which have passed GMP inspection of China and other countries several times.
There are various platforms for quality management, quality control and antibody quality research, which are equipped with many sets of advanced analysis instruments, such as capillary electrophoresis apparatus (CE), the highly effective liquid phase color spectrometer, a real-time quantitative PCR, cell flow analyzer, gel imager, TOC analyzer, Maurice and so on. With cutting-edge pharmaceutical analysis methods, BPL can independently develop analytical methods, validation, and antibody quality research and so on. Per to the invitation by China National Institutes for Drug Control, the Quality Dept. has participated in the calibration of the standard of biological substances, new methods development and works in relation to pharmacopoeia and so on.