May 20, 2021
147 days after the hard work of all employees of BiBo Pharma, the Lin-Gang Phase I Project (P02) of large-scale CDMO integrated production platform for biologics of BiBo Pharma was officially completed by the BiBo Engineering Department. This marks China’s first and one of the only technically-integrated GMP production platform for biologics in the world to enter the stage of verification and trial operation. BiBo Pharma Lin-Gang Phase I technically-integrated GMP production platform covers mammalian cell culture (2,000L one-time), microbial fermentation (2,000L stainless steel), gene therapy (BSL2, 500/2,000L) and preparation filling (freeze-dried injection, water injection, pre-filling injection) production line. The total capacity is more than 15,000 liters.
At the opening ceremony, Dr. Jiao Peng, Chairman and CEO of BiBo Pharma, said, “Since the commencement of construction on December 24, 2020, the BiBo Pharma Lin-Gang Phase I Project has been completed in a record-breaking 147 days in the face of epidemic situation, extreme tension of global supply chain, various holidays and many other external troubles, which fully reflects the deep technical engineering foundation accumulated by the BiBo team over the years and its strong project planning, organization and implementation ability. This is the result of the successful implementation of the PanFlexTM project system independently innovated by BiBo in Shanghai.”
With the implementation process of BiBo Pharma Lin-Gang Phase I Project, 13 sub-project modules started in time, and completed at the same time, with multi-scale and multi-latitude efficient integration. The project was completed with fastest speed and highest quality in the world with the innovative implementation system of biologics engineering. The construction and implementation of this project also fully demonstrates the strong deployment ability of BiBo Pharma in the global biologics supply chain.
BiBo’s advanced engineering technology system responded well to many challenges including COVID-19, domestic and foreign suppliers (such as from the United States and Germany) actively promoting the opportunity to cooperate with the advanced system of BiBo, overcoming their own capacity shortage, and organizing a special team to give priority to the construction and equipment production of the project. It showcased the advanced technology of the BiBo engineering system that has been recognized by international and domestic suppliers, which ensures the smooth progress of the project.
BiBo also focuses on supporting high-quality domestic equipment partners; promoting domestic equipment improvement and iterative development in practical application scenarios.
As an international advanced engineering case, the BiBo Pharma Lin-Gang Phase I Project implemented by PanFlexTM engineering system will be used in an MIT (Massachusetts Institute of Technology) teaching video and included in its teaching system.
The efficient and successful implementation of BiBo Pharma Lin-Gang Phase I Project has been highly praised and supported by Shanghai municipal leaders and Lin-Gang Special Areas Administration. Therefore, the leaders of the Lin-Gang Special Areas Administration decided to accelerate the support for the implementation of the Phase II Project.
On April 30, Zhu Zhisong, Member of the Standing Committee of Shanghai Municipal Party Committee, Secretary of Party Working Committee and Executive Deputy Director of Lin-Gang Special Areas Administration, and Wu Xiaohua, Member of Party Working Committee and Full-time Deputy Director of Lin-Gang Special Areas Administration, visited the BiBo Pharma Lin-Gang Phase I Project.
Secretary Zhu expressed his appreciation to BiBo Pharma Lin-Gang Phase I Project for overcoming difficulties, promoting the project, and working with amazing construction speed. He hoped that BiBo would seize the development opportunities and the “window period” of the industry, continue to strengthen the leading edge of PanFlexTM engineering technology, and continuously enhance the core competitiveness of the enterprise as well as break through the monopoly of key technologies, build an international CDMO industry leader, and set a world leading industry benchmark.
The excellent implementation of BiBo Pharma Lin-Gang Phase I Project has laid a solid foundation for the construction of the Phase II Project. The BiBo Pharma Lin-Gang Phase II Project (P03) will build the world’s first largest single tank, a 30,000-liter stainless steel production platform, which will fill the key gap in the process of biologics industrialization in China, answer the problems in biologics production in China, and realize the vision that people in China and even the world can use and afford quality medicines.
P03 project Launching Ceremony Lin-Gang Phase II Project (P03) is scheduled to be completed and put into operation by the end of 2022.