Integrated Continuous Manufacturing of Therapeutic Protein Drug Substances



A U.S. Patent for “Integrated Continuous Manufacturing of Therapeutic Protein Drug Substances” was awarded to Sanofi on July 14th, 2020. The present invention isa process for manufacturing a drug substance comprising a recombinant .alpha.-galactosidase-A, the process comprising: (a) culturing cells in a perfusion bioreactor comprising a liquid culture medium under conditions that allow the cells to secrete the recombinant .alpha.-galactosidase-A into the medium, wherein at least 90% cell-free volumes of the medium are continuously or periodically removed from the perfusion bioreactor and fed into a periodic counter current… Learn More