BiBo Pharma is new to China’s contract development and manufacturing organization (CDMO) industry, but it has ambitions to be a game-changer. The project, named P03 and located in Shanghai, has a total planned minimum capacity of 200,000 liters. It will include “the world's first stainless steel single mammalian cell production line with a capacity of 30,000 litres in total volume,” the company said in late August.
After the completion of the stainless steel mammalian cell culture production line the core key gap in the industrialisation of biopharmaceuticals in China can be bridged.
Last May, the Lingang Phase I Project (P02) of large-scale CDMO integrated production platform for biologics of BiBo Pharma was officially completed by its Engineering Department and handed over to the Production Department. It is one of the few fully-technical integration production platforms in the world and the first in China. The GMP production platform has entered the stage of verification and trial operation. BiBo Pharma Lingang Project Phase I full-technology integrated 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 with a total capacity of more than 15,000 litres.
The ultimate goal of biopharmaceutical process development and production is to deliver high-quality products while reducing costs and time. The significance of a single can of 30,000 litres lies in this.
Since the establishment of the Lingang new area, more and more biopharmaceutical companies have chosen to locate their production bases in the “Life Science Blue Bay ” industrial park, including many CDMO (R&D and Production Outsourcing Organisation) companies with high-tech thresholds.
What they are looking for is not only the strong industrial support policies in the new area, the ample and well-prepared space for advanced manufacturing industries, but also the ever-improving speedy services of the local governments The "spillover effect" brought about by such frontier industrial agglomeration will also bring new momentum to the development of the new area.