PROCESS TO PURIFY A PROTEIN OF INTEREST FROM A FLUID HYPEROGENIC TISSUE CULTURE MIXTURE AND APPLIANCE TO SEPARATE A PROTEIN OF INTEREST OF THE FLUID HETEROGENIC TISSUE CULTURE

摘要

"Devices and methods for continuous integrated manufacturing of biological molecules". This invention relates to a process and apparatus for purifying a molecule of interest from a heterogeneous clarified fluid mixture. The apparatus of the invention generally consists of a continuous perfusion fermentation system, a continuous particulate removal system integrated with the perfusion fermentation system; and a continuous purification system integrated with the particulate removal system, which is maintained under sterile conditions. The process consists of filtering a clarified and heterogeneous fluid mixture by continuous ultrafiltration at a specific flow rate below the transition point of the molecule of interest in the flow region that depends on the pressure relative to the tmp curve, where the flow rate is kept considerably constant throughout continuous ultrafiltration.