Clearing trace HCP, DNA and viruses in the manufacture of biologics: A novel single use anion exchange membrane adsorber

BIOT 255

Alejandro Becerra-Arteaga1, Jim Neville, jim_neville@millipore.com1, and Michael W. Phillips, michael_phillips@millipore.com2. (1) BioProcess Engineering Group, Millipore Corporation, 900 Middlesex Turnpike, Billerica, MA 01821, (2) Research and Technology Development, Millipore Corporation, 80 Ashby Road, Bedford, MA 01730
Purification of greater protein mass, from higher fermentation titers can lead to bottlenecks downstream both in terms of unit operations capacity and subsequent preparations of buffers. A unique disposable flow through anionic membrane adsorber, is described .This is designed to replace the anion exchange column in a traditional chromatography polishing template. The characteristics of the support membrane, unique gel surface coating and device flow distribution are described. A unique feature of the membrane chemistry is the ability to bind impurities at high conductivities (14mS) eliminating the need for cation pool dilution .Data is shown from MAB feedstocks where purity targets of HCP to <10 ppm, DNA >3 LRV, Virus >4 LRV were achieved.
 

Downstream Processing: Emerging Technologies for Downstream Processing
8:30 AM-11:25 AM, Tuesday, August 19, 2008 Philadelphia Marriott -- Franklin 3, Oral

Division of Biochemical Technology

The 236th ACS National Meeting, Philadelphia, PA, August 17-21, 2008