Shanghai Bailun Biotechnology Co., Ltd.
Applications
Biosimilars
Bailun Biotech is committed to providing a full-process solution for biosimilars such as antibody drugs and recombinant proteins, from reference drug characterization analysis, process development to commercial production. We analyze the key quality attributes (CQA) of the original drug through reverse engineering, and combine the independently constructed high-expression cell line library and the step-by-step purification process development platform to ensure that the candidate molecules of generic drugs are highly consistent with the original drug in core indicators such as amino acid sequence, glycosylation modification, and biological activity. For production process optimization, we develop a cell culture parameter control, virus inactivation verification, and formulation stability research system based on quality by design (QbD), with more than 50 physical, chemical and functional tests, fully covering the review requirements of FDA, EMA and NMPA for biosimilars. At present, the process development of several blockbuster drugs such as trastuzumab and adalimumab has been successfully completed, and the key quality data have been reviewed by a third-party authoritative agency, helping pharmaceutical companies to break through the original research technology barriers, accelerate the listing of cost-effective biological drugs, and provide affordable clinical drug options for patients with tumors, autoimmune diseases, etc.
Shanghai Bailun Biotechnology Co., Ltd.
Liu Xiang Road 6848， Hua Ting Town, Jiading District, Shanghai
