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 technologies.
High-density cell storage technology: compared to the traditional technology, cell storage density is increased by more than 10 times from 10E7 per mL, and the cell viability has reached above 98%.
Main bioreactor production process: the main bioreactor repeats the incubation start-up time cycle, reduced from the current 20 days to 10 days.
Through the new generation of high-efficiency cell culture production technology, we have made a comprehensive innovation in the upstream production process of biopharmaceuticals, so that the production process of biopharmaceuticals in China has reached the highest level worldwide. The overall efficiency of the upstream process of biopharmaceutical production increases by more than 25% overall, the production cycle will be shortened by 30%, and the production cost will be reduced.
B. Rapid Single-Cell Screening Platform Technology
BiBo Pharma’s rapid single-cell high expression screening platform utilizes a combination of advanced processes and equipment, that allows one round of single-cell screening with regulatory compliance, resulting in a nearly 30% reduction in cell line development cycle time (6 weeks less 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.