Shanghai BioEngine Sci-Tech Co., Ltd.

Shanghai BioEngine Sci-Tech Co., Ltd was founded on December 24, 2014, in Shanghai China. We specialize in providing high-quality & cost-effective cell culture media and related technical services in antibody, vaccine, and cell & gene therapy fields. Our headquarters and R&D center are located in Shanghai Zhangjiang Hi-Tech Park, and Our Phase II manufacturing site (Shanghai Beijin Biotech Co., Ltd.) is located in Jinshan, Shanghai.

Since the establishment of BioEngine in 2014, we have grown rapidly and developed nearly 100 types of serum-free media for different cell lines, including Eden series serum-free medium for CHO cells, HIPP series serum-free medium for immune effector cells for cell therapy, serum-free medium for vaccine production of Vero, HEK293, MDCK, PK15, BHK, MDBK, insect cells, etc. Our media supports high-density cell culture and efficient expansion, outperforming other well-known media products. Our products make cell products easier to be purified and processed in downstream process, which is effectively improving the safety and yield of cell products, as well as significantly reducing production costs for customers. Our product quality and technical service level have outperformed similar imported products and are highly appreciated by domestic biopharmaceutical companies.

Up to now, BioEngine has supported more than 80 clinical projects in the biopharma industry, including antibodies, vaccines, and cell and gene therapy, and has provided nearly 100 cell culture technology services, with many "first in China" and "first in the world" project achievements. In the field of antibody, BioEngine helps customers to launch the antibody fusion protein drug, which is the first domestic application of domestic culture medium formulation and process. In the field of vaccine, the company has completed the world's first and launched project of producing human/avian influenza vaccine based on MDCK cell serum-free suspension culture technology, the first domestic human vaccine (phase III clinical) project based on VERO cell serum-free culture technology. In the field of cell therapy, BioEngine has independently developed the HIPP-T009 series immune effector cell culture medium. It has become the first completely serum-free medium launched in China for high-density culture and maintenance of CAR-T cells and NK cells, which is also the first domestic culture medium used for cell therapy clinical trial declaration (CTA) and passed the CDE audit in China.

In the end of 2021, the Phase II culture media production base (Shanghai Beijin Biotech Co., Ltd) commenced full operation. This production base is a world-class factory that is built according to ISO13485:2016 quality management system, GMP, and MDSAP multi-system requirements, using the Lean Six Sigma (LSS) system for production management. The production base has realized the consistency amplification of the low-temperature CMPM (Cone Mixing/ Pin Mill) powder process at the level of 1,000 liters, 10,000 liters, and 100,000 liters, and the maximum production batch can reach 100,000 liters. The annual capacity of the powder medium is 55 million liters, and the annual capacity of the liquid medium is 250,000 liters. Our products meet the requirements of culture media for US FDA certification and EU product registration declaration and other related regulations.

BioEngine is dedicated to empowering local innovative biopharmaceutical products such as antibodies, vaccines, and cell therapies to go abroad and realize the dual declarations of China-US and China-EU with our stable and reliable high-quality culture media.

BioEngine is committed to empowering the development and production of innovative biopharmaceutical products with consistent and reliable high-quality culture media products and services for the benefit of human health worldwide.

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