318731 Process Development Comparison of Single Use Clarification Technologies for Mammalian Cell Cultures Utilizing a Conventional Two-Stage Depth Filtration, a New Optimized Depth Filter and a Novel Single-Use Fluidized Bed Centrifuge With Depth Filtration

Juan C. Castano1, Matthew M. Westoby2, Sanaa Elouafiq2 and Devin McCann2, (1)Biomanufacturing Science Network (BSN), EMD Millipore Corp., Billerica, MA, (2)Technical Development, Biogen Idec, RTP, NC

Single-use cell culture harvest technologies have been challenged considerably by cell culture development leading to higher productivity and cell densities with equivalent increased impurities and debris. 

Conventional two-stage adsorptive depth filtration is currently used as a single use strategy for cell culture clarification, however, high density cell culture processes and increased batch volumes can impact depth filtration performance and render facility fit limitations. 

A collective evaluation with multiple antibodies was accomplished to make a direct comparison of mammalian cell cultures at native and low pH (acid precipitate to induce flocculation) conditions utilizing a conventional two-stage depth filtration,  two-stage single-use centrifuge with fluidized bed coupled with depth filtration and single-stage new optimized depth filtration. 

This presentation will compare the results for each technology based on their performance at clarifying high-density cell cultures, reduction of impurities, recovery, and depth filtration to depict an optimal and feasible solution for single-use harvesting of high density cell cultures.


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