On July 2, the QbD full life cycle seminar for biopharmaceutical production facilities sponsored by the School of Continuing Education of Shanghai Jiao Tong University was successfully held at Shanghai Jiao Tong University. Ding Zhijie, vice president and chief designer of TIANS Group, was invited to attend and gave a special training on "Engineering Design of Biological Products (Mab, Cell Therapy, Gene Therapy) and Facilities". Focusing on topics such as clean plant design and compliance management, nearly a hundred decision-makers related to R&D, technology, quality, and engineering from major pharmaceutical companies across the country gathered together to seek common development. After the training, they were awarded by Shanghai Jiaotong University. Certificate of completion.

Ding Zhijie combined his years of project design experience, from the characteristics and dosage forms (URS) of biological products (monoclonal antibodies, cell therapy and gene therapy drugs), the regulations that the project needs to comply with (GMP), and the prevention and control of cross-contamination (Risk). Assessment), the impact of the production process on the environment and prevention (EHS), the impact of the production process on the operators and prevention (EHS) and the consideration of biological safety in the design, the setting of the flow of people, logistics, waste flow, and the setting of the purification air conditioning system , Self-control and other five areas of focus have been carefully shared.

As a strategic development industry in my country, biopharmaceuticals have developed vigorously in recent years, and a large number of R&D projects have entered the stage of applying for clinical and applying for production. Monoclonal antibodies, double antibodies, tertiary antibodies and even polyclonal drugs, ADC drugs, CAR-T, CAR-NK and other drugs or therapies have become the fastest growing and most active fields. A group of industry experts including Guo Aijun, chief expert of the American Research Center of the University of International Business and Economics, Ni Jianhong, chief engineer of Shanghai Boehringer Ingelheim Pharmaceuticals, and Zheng Huailiang, vice president of IT of Cinda Biopharmaceutical Group Detailed reports were made on topics such as enterprise informatization construction.

As a leading domestic one-stop solution provider for biomedical engineering projects, TIANS Group has served many leading biopharmaceutical companies such as Junshi Biology, Heyuan Biology, Maiwei Biology, etc., and has many national standard drafters. A team of leading experts in the industry has participated in and led the construction of nearly 100 biopharmaceutical factory facilities that comply with China's new GMP and FDA requirements, and is in an industry leading position in the design and construction of biomedical laboratories.