Industrial scale harvest of proteins from mammalian cell culture by tangential flow filtration.

An industrial-scale methods for harvest of biologically active proteins form mammalian cell culture has been developed using tangential flow filtration. A robust and economical process capable of processing approximately 5000 L conditioned media/h with protein yields in excess of 99% has been achieved. A completely contained system has been designed in which total cell number and viability are maintained throughout the process. The process has successfully been implemented at 1.25 x 10(4) L scale for the recovery of kilogram quantities of pharmaceutical proteins such as recombinant tissue type plasminogen activator (rt-PA).