Traditionally, a biological drug takes up to one and a half years from research and development (R&D) to GMP production. BiBo’s new R&D and manufacturing technologies including ‘Rapid Single-Cell Screening Platform Technology’, ‘High Throughput Process Development’, ‘New Generation High-Efficiency Cell Culture Production Process Technology’, and BiBo’s Grand-CHO platform will speed up the overall development of biopharmaceutical process and enable the manufacturing of the first GMP batch in 9 months, reducing the overall time by more than 50%. 

A. New Generation High-Efficiency Cell Culture Production Technology 

The New Generation High-Efficiency Cell Culture Production Technology includes high-density cell storage technology, primary bioreactor production process, and other production process technology platforms. 

High-density cell storage technology increases cell storage density by more than 10 times compared to traditional methods, reaching 10E7 per mL. Cell viability has also exceeded 98%.

Main bioreactor production process: the main bioreactor repeats the incubation start-up time cycle, reduced from the current 20 days to 10 days. 

We have developed a new generation of high-efficiency cell culture production technology. This has led to comprehensive innovation in the upstream production process of biopharmaceuticals. As a result, China’s biopharmaceutical production process has reached the highest global level. The overall efficiency of upstream production has increased by over 25%. Additionally, the production cycle is shortened by 30%, and production costs are reduced.

B. Rapid Single-Cell Screening Platform Technology

BiBo Pharma’s rapid single-cell high expression screening platform uses advanced processes and equipment. This allows a single round of screening with full regulatory compliance. As a result, cell line development cycle time is reduced by nearly 30%, saving six weeks of development time.). 

C. High Throughput Process Development 

BiBo’s process development utilizes high throughput screening equipment and efficient DoE methodology to achieve high-throughput and rapid process development, resulting in a 30-50% reduction in the R&D timeline.