Shanghai Bailun Biotechnology Co., Ltd.
Applications
Vaccine Process and Production
Based on the internationally accepted quality management system (GMP) and mature process development platform, Bailun Biotech provides a full-chain solution from process development to large-scale production for recombinant protein vaccines, viral vector vaccines and mRNA vaccines. We achieve efficient antigen expression and precise impurity control through in-depth optimization of mammalian cell expression system, serum-free suspension culture technology and chromatography purification process, ensuring batch-to-batch consistency and stability of vaccine products; for the development of viral vaccines, we establish virus seed bank construction, large-scale amplification and ultrafiltration concentration processes, and strictly test key quality attributes such as host cell DNA residues and exogenous viral factors, fully meeting the requirements of the "Chinese Pharmacopoeia" and FDA/EMA regulations. Relying on digital bioreactors, continuous flow production technology and freeze-dried preparation development experience, it can support seamless connection from preclinical sample preparation to commercial production, and accelerate the research and development process of new vaccines. At present, the process development of multiple projects including influenza virus-like particle vaccine and new crown recombinant protein vaccine has been completed, and the core quality control indicators have been verified by the National Institute for Drug Control, providing reliable technical support for the prevention and control of infectious diseases and the industrialization of new vaccines.
Shanghai Bailun Biotechnology Co., Ltd.
Liu Xiang Road 6848， Hua Ting Town, Jiading District, Shanghai
