CENTRIFUGE/FILTRATION SYSTEM OR BIOPROCESS CLARIFICATION

DESCRIPTION (applicant's abstract): This project proposes to build and verify a highly efficient lab scale centrifuge with a sterile disposable liner incorporating a sub-micron filter element within the centrifuge to create a very robust method to clarify and sterilize cell cultures used in the manufacture of recombinant biopharmaceuticals. The efficiency and speed of the centrifugation process for a cold mix of cells and medium has been predicted using fluid dynamics modeling. Throughputs of 81i/min using a 5 liter lab scale device are attainable with 10,000 g's. The device and methods proposed will produce a very fast and thorough purification and clarification of product laden growth media. Cell lysis will be minimized due to the relative speed of the process and the low shear and heating environment. With this process very clean product may be produced. Lab Scale test with yeast, bacterial and mammalian cell cultures will be performed by Dr. Alexander Dilorio, Director of Bioprocessing Laboratory at Worcester Polytechnic Inst. to demonstrate the usefulness of the new equipment and process. Comparative testing versus existing methods of filtering and centrifugation will be performed using established assay methods for the presence of cells and cell debris as well as indicators of cell lysis. PROPOSED COMMERCIAL APPLICATION: Proposed device and methods are applicable to the clarification and sterilization needs of recombinant biopharmaceutical processing at the lab scale. It will be possible to scale up the device for pilot scale and manufacturing needs.