BiBo Milestone | 147 days of speed and passion: the first fully integrated biopharmaceutical GMP production platform in China - BiBo Biotech Lingang Phase I Project (P02) was officially delivered

Time: 2021-05-23  /  View: 4,140 times

After 147 days of efforts by all staffs of Shanghai BiBo, on May 20, 2021, Shanghai BiBo Biopharmaceuticals large-scale CDMO integrated production platform Lingang Phase I (P02), was officially handed over from BiBo Engineering Department to Manufacture Department, marking the verification and commissioning stage of the very few among the world, and the first full-technology integrated biopharmaceutical GMP production platform in China. BiBo Lingang Phase I fully-technology integrated platform covers mammalian cell culture (2000L SUB), microbial fermentation (2000L s.s.), gene therapy (BSL2, 500/2000L) and formulation filling (lyophilization, liquid vial, pre-filled syringe) production lines with a total capacity of over 15,000 liters.

At the handover ceremony, Dr. Jiao Peng, CEO of the BiBo Pharma, said, "Since the construction started on December 24, 2020, the BiBo Lingang Phase I project has been completed in a record of 147 days, under many external factors such as the raging epidemic, extremely tight global supply chain and lots of days that not suitable for constructions, which fully reflects the ability to plan, manage, and execute projects, also the strong and mature technical engineering expertise accumulated by the BiBo team over the years. It is the result of the successful implementation of BiBo's own innovative PanFlex® engineering system in Shanghai Lingang."

During the implementation of BiBo Lingang Phase I project, thirteen sub-project modules were started in time, worked parallelly and completed at the same time with efficient integration at multiple scales and latitudes, ensuring that the project was completed with the fastest speed and high quality in international scale with an innovative biopharmaceutical engineering implementation system. The implementation of this project also fully demonstrates BiBo's strong deployment capability in the global biologics supply chain. BiBo's advanced engineering system has received international and domestic recognition and positive response: in the face of the challenges of the new COVID epidemic, domestic and international suppliers (e.g. from US and Germany) actively promoted the opportunity to cooperate with BiBo's advanced system, and overcame the challenges of their own capacity shortage to set up a special team to give the highest priority to BiBo's project for engineering construction arrangements and equipment production. This is the result of BiBo's advanced engineering system being recognized by international and domestic suppliers, which ensured the smooth progress of the project.

BiBo also focuses on supporting quality domestic equipment partners; promoting the improvement and consecutive development of domestic equipment in practical application scenarios.

The first phase of the Lingang project implemented in BiBo's PanFlex® engineering system will be used as an international advanced engineering case to made up a teaching video for MIT (Massachusetts Institute of Technology) and will be kept in the MIT teaching system.

P02Live scene
SHOTS

The efficient and successful implementation of BiBo Lingang Phase I project has been highly praised and supported by the leaders of Shanghai and the Lingang Administrative Committee. For this reason, the leaders of Lingang Administrative Committee decided to accelerate the support of BiBo Lingang Phase II project implementation.

On April 30, Zhu Zhisong, member of the Standing Committee of Shanghai Municipal Committee, Secretary of the Party Working Committee of Lingang New Area and Executive Deputy Director of the Management Committee, and Wu Xiaohua, member of the Party Working Committee of Lingang New Area and full-time Deputy Director of the Management Committee, investigated the first phase of BiBo Lingang project. Secretary Zhu expressed his appreciation for the project of BiBo Lingang Phase I for pushing forward the project with great difficulties and creating amazing construction speed. He hoped that the company would seize the development opportunities and industrial "window period", continue to strengthen the leading edge of PanFlex® engineering technology, and continuously improve the core competitiveness of the enterprise; break through the monopoly of key technologies, build a leading company of international CDMO industry, and set a world-leading industry benchmark.
The excellent implementation of BiBo Lingang Phase I project has laid a solid foundation for the construction of Phase II project. The second phase of the project (P03) will build up the first and largest 30,000L mammalian stainless steel production platform in the world, filling the core key gap in the industrialization of biological drugs in China, solving the problem of the production of biological drugs in China, and realizing the vision of making drugs available, affordable and accessible (easily obtained, affordable and high-quality) to the people of China and the world.

P03project
Launching ceremony

Lingang phase II project (P03) is planned to be completed and put into operation by the end of 2022.