BIOENFINE

Shanghai Beitongji Biotechnology Co., Ltd. (BIOENFINE) was founded in December 2014 by Professor Tan Wensong's team from East China University of Science and Technology. It focuses on large-scale, high-density serum-free suspension culture technology services for animal cells and the development and manufacturing of raw materials. The company provides high-quality one-stop services to biopharmaceutical enterprises, ranging from cell culture process development and optimization, medium formulation design to medium processing and manufacturing. The company’s headquarters and R&D center are located in Shanghai Zhangjiang Med Valley, while its Phase II production base (Shanghai Beijin Biotechnology Co., Ltd.) is situated in Jinshan, Shanghai. Since its establishment in 2014, BIOENFINE has grown rapidly and independently developed nearly a hundred catalog-type serum-free media for different cells. These include the Eden series of CHO cell serum-free media for antibody protein expression, the HIPP series of immune effector cell serum-free media for cell therapy, and serum-free media for vaccine production such as Vero, HEK293, MDCK, PK15, BHK, MDBK, and insect cells. These products support high-density cell culture and efficient expansion with superior performance compared to other well-known media products, making purification and downstream processing easier. They effectively enhance the safety and yield of cell products while significantly reducing production costs for customers. The quality of the products and technical service levels surpass imported counterparts, earning widespread recognition and praise from companies in China's biopharmaceutical industry. To date, BIOENFINE has supported over 80 clinical submission projects in the fields of antibodies, vaccines, and cell/gene therapies, providing nearly a hundred cell culture technical services and achieving numerous breakthrough project results both domestically and internationally. In the field of antibodies, BIOENFINE has helped domestic clients bring antibody fusion protein drugs using locally produced medium formulations and processes to market. In the vaccine field, it completed an already marketed human/avian influenza vaccine project based on serum-free suspension culture technology for MDCK cells in 2016, and a human vaccine project (Phase III clinical) based on serum-free culture technology for Vero cells in 2019. In the area of cell therapy, the HIPP-T009 series of immune effector cell culture medium independently developed by BIOENFINE as early as 2019 became a truly serum-free medium suitable for high-density culture and maintenance of CAR-T cells and NK cells. It was also the first domestically produced medium used for clinical trial applications in cell therapy and approved by the CDE. By the end of 2021, BIOENFINE’s Phase II medium production base (Shanghai Beijin Biotechnology Co., Ltd.) was fully operational. This facility was constructed according to the ISO13485:2016 quality management system, GMP, and MDSAP multi-system requirements and uses the LSS Lean Six Sigma system for production management. It achieved consistent scale-up of low-temperature needle grinding powder processes at the thousand-liter, ten-thousand-liter, and hundred-thousand-liter levels, with a maximum batch size of 100,000 liters, an annual production capacity of 55 million liters of powdered medium, and 250,000 liters of liquid medium. BIOENFINE’s products meet the requirements of US FDA certification and EU product registration submissions related regulations for media. BIOENFINE is committed to supporting the research and production of innovative biopharmaceuticals such as antibodies, vaccines, and cell therapies worldwide with stable and reliable high-quality medium products and services, contributing to human health.