Shanghai Bailun Biotechnology Co., Ltd.
Applications
Monoclonal Antibodies
Bailun Biotech has built a full life cycle service system covering antibody discovery, process development and GMP production, providing high-affinity, low-immunogenicity monoclonal antibody solutions for tumor treatment, autoimmune diseases and targeted drug development. We achieve efficient development of antibody candidate molecules through hybridoma technology, phage display library and single B cell screening platform; based on mammalian cell expression system, we optimize cell line construction, serum-free suspension culture and continuous flow purification process to ensure that the antibody product meets the international pharmacopoeia standards in key quality attributes such as glycosylation modification and polymer control. For complex molecules such as bispecific antibodies and ADC drugs, we develop site-specific coupling, stability enhancement and formulation optimization technologies, and provide more than 30 quality control tests such as host protein residues and endotoxins to fully meet the regulatory requirements of FDA/EMA and NMPA. At present, we have completed the development of multiple therapeutic antibody projects including PD-1/PD-L1 inhibitors and IL-6R antagonists. The process system has been verified by commercial production of cooperative pharmaceutical companies, providing reliable technical guarantee for the clinical transformation and large-scale supply of innovative antibody drugs.
Shanghai Bailun Biotechnology Co., Ltd.
Liu Xiang Road 6848， Hua Ting Town, Jiading District, Shanghai
