R&D
Process Development
Cell Line Development

Hongcheng stable cell line construction platform has two host cell systems, GS wild type and deletion type. Through transient transfection or rapid stable transformation of pool cells, it can provide milligram to gram samples to support drug-resistance research. Within 3 months, we can complete the screening from transfection to monoclonal. The whole experiment process uses commercial, chemically defined medium, with monoclonal planking and microphotograph equipment, which effectively proves the source of monoclonal, and provides stable, high-yield and quality cell lines for the development of cell culture technology. Support the establishment of main cell bank and working cell bank meeting GMP requirements, and provide seeds meeting GMP production for later clinical samples and commercial production.
Upstream Process


Focus on mammalian cell culture process development, process amplification, and technology transfer. We have experienced research and technical team, and implement the concept of quality comes from design (QBD) in the process of process development. The research platform can carry out upstream process development including traditional batch fed batch culture, concentrated fed batch culture and perfusion culture. The research work adheres to the end-to-end strategy to meet the needs of Sino US ind application, clinical batch production and commercial production of biopharmaceutical research and development.
上游工艺-宏成
Process Development

The backbone members of the downstream process development team of HONGCHENG. have worked in this field for more than 10 years and accumulated rich experience, including various purification process development, process amplification, technology transfer to cGMP production, etc. Product types include recombinant protein, monoclonal antibody, bispecific antibody, fusion protein, antibody fragment, etc. It has a complete platform to support process R&D. Each purification step was optimized. Risk assessment and definition of key process parameters (PCPP). 3L scale process development, 15 / 50L scale process confirmation, 200L scale pilot production.
Quality Science
The quality analysis platform of the quality control center, which is gradually improving, includes structure characterization,biophysical analysis, biological activity, microbial control (under construction), raw and auxiliary material release (under construction), etc., which can provide drug evaluation, process development support, DS / DP release, stability research, microbial control, environmental monitoring,and other services for complex antibody drug development and production Quality analysis support for raw materials release.
Structure characterization platform:a complete and mature structure characterization and analysis platform has been established, which can support the characterization research of intact mass, HC / LC mass, Fab / FC mass, peptide mapping, distribute bond, N-glycan and post translational modification, and provide characterization research support for complex process research and development,product production and research.
Biophysical analysis platform:the biophysical analysis platform established in Zhangjiang R&D center can provide full chain analysis support from product R&D to ind declaration; At the same time, higher standard biophysical analysis platforms are being set up in the pilot production center near Lingang and the commercial production center of Kangqiao.
Activity analysis platform:P2 Laboratory of Zhangjiang R&D center has been put into use, which can provide activity analysis support including binding activity, cell function activity, affinity characterization, etc. for product development and ind application; At the same time, the pilot production center in Lingang and the commercial production center in Kangqiao are building higher standard activity analysis platforms respectively.
Microbial control:complete microbial control and analysis platforms are being established in Lingang pilot production center and Kangqiao commercial production center, including sterile laboratory, micro limit laboratory, positive bacteria laboratory, etc.
Raw materials release:a complete raw materials release platform is being established in Kangqiao commercial production center.
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