“With this, we have opened up scaled-up commercialization for our clients,” said John Lim, vice president at Samsung BioLogics, who is in charge of Plant No. 3.
|Plant No. 3 (Samsung BioLogics)|
The South Korean contract manufacturing organization will customize its cell-culturing methods for each client, expanding the portfolio of bio drugs that Samsung BioLogics can manufacture, he added.
The adoption of N-1 Perfusion in a large manufacturing facility like Samsung BioLogics’ Plant No. 3 is a rare case, the company said. The plant’s production capacity is 362,000 liters.
The “N-1” in the technology’s name signifies “the step before N,” with N representing the final stage of cell culturing for the manufacturing of a bio drug. As cells grow, N-1 Perfusion filters out impurities simultaneously. With a longer N-1 period, more cells can grow, leading to greater density and enhanced productivity.
This new method compensates for a technical drawback that had limited the amount of cell culturing that could be carried out due to the accumulation of waste inside the incubator. N-1 Perfusion has been used on a smaller scale so far, to manufacture drugs for clinical trials. But it will also be applicable for Samsung’s commercialization-scale production.
Plant No. 3, which began operation in October 2018, boasts the biggest cell-culturing facility in the world so far, with a total manufacturing capacity of 362,000 liters in a single generation. The new plant had considered the adoption of N-1 Perfusion technology from the blueprint stage, Samsung BioLogics said.
By Lim Jeong-yeo (email@example.com)