Shanghai Bailun Biotechnology Co., Ltd.
Applications
Cell Therapy
Bailun Biotech focuses on the field of immune cell and stem cell therapy, providing full-process solutions that meet international standards for tumors, degenerative diseases and immune system diseases. Based on T cell enrichment and activation, CAR gene vector construction and stem cell directed differentiation technology, we have established a closed-loop process system from cell collection, functional modification to cryopreservation and resuscitation, strictly following GMP specifications and pharmacopoeia guidelines, and ensuring the clinical safety of products through more than 50 quality control nodes such as cell identity identification, microbial safety testing and genetic stability analysis. In the direction of immune cell therapy, we optimize the CAR-T cell viral transduction process and NK cell expansion program, and provide a cytokine release syndrome (CRS) risk assessment model to significantly improve the response rate of solid tumor treatment; in the field of stem cell therapy, we use mesenchymal stem cell serum-free expansion and iPSC directed differentiation technology to support clinical needs such as bone and joint repair and myocardial regeneration. The exosome freeze-dried preparations developed by us break through the liquid storage limitations, and the activity retention rate is at the industry-leading level. At present, the technological achievements have been successfully applied to the process development of CD19 CAR-T drugs and the production of drugs for clinical trials in tertiary hospitals. The key quality control indicators have been reviewed by the China National Institute for Food and Drug Control, helping cooperative pharmaceutical companies to achieve industrialization from process development to large-scale production, providing patients with more accessible and safer cell therapy options.
Shanghai Bailun Biotechnology Co., Ltd.
Liu Xiang Road 6848， Hua Ting Town, Jiading District, Shanghai
