Shanghai Bailun Biotechnology Co., Ltd.
Applications
Gene Therapy
Bailun Biotech focuses on the clinical transformation of viral vectors and gene editing technologies, providing safe and controllable gene therapy product development services for monogenic genetic diseases, tumors and rare diseases. Based on AAV vector optimization, lentiviral vector packaging and CRISPR/Cas9 gene editing technology, we have built a full-chain technology platform from target design, vector production to functional verification, strictly following GMP specifications and the "Technical Guidelines for Pharmaceutical Research and Evaluation of Gene Therapy Products" to ensure that the vector titer, purity and gene editing specificity meet clinical quality standards. Through the independently developed targeted delivery system and tissue-specific promoter, the transduction efficiency of gene drugs in target organs such as the retina, nervous system and liver is significantly improved. At the same time, the off-target effect detection and immunogenicity evaluation system are used to comprehensively reduce the treatment risk. At present, the technical solution has been applied to the development of therapeutic drugs for diseases such as hereditary retinopathy and hemophilia B. Among them, the recombinant AAV vector production process has passed the compliance verification of the China National Institute for Inspection and Quarantine, supporting the production of drugs for multiple clinical trials, and providing key technical support for the industrialization of gene therapy and the improvement of patient accessibility.
Shanghai Bailun Biotechnology Co., Ltd.
Liu Xiang Road 6848， Hua Ting Town, Jiading District, Shanghai
