Performance of small virus filters during extensive processing

BIOT 130

Kurt Brorson, kurt.brorson@fda.hhs.gov1, Scott Lute, lute@cber.fda.gov1, and Mark Bailey2. (1) Division of Monoclonal Antibodies, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg 64, Rm 1036, 10903 New Hampshire Ave, Silver Spring, MD 20903, (2) Eli Lilly and Co, Indianapolis, IN 46285
Retention of a two small bacteriophages (ÖX-174 and pp7) by small virus filters (Viresolve NFP, Virosart CPV, Ultipor DV20 and Planova 20N) was studied using a commercial process fluid. Virus breakthrough occurred in each filter type, particularly when overloaded. A relationship was noted between flux decline and loss of viral clearance with some filter brands but was less clear with others. A better understanding of the impact of extended processing on filter performance will enable the establishment of meaningful end point definitions for validation studies and large scale processing.
 

FDA Symposium: Process Development and Validation
8:00 AM-11:20 AM, Tuesday, 12 September 2006 Hilton San Francisco -- Imperial A Ballroom, Oral

Division of Biochemical Technology

The 232nd ACS National Meeting, San Francisco, CA, September 10-14, 2006