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Volume 7, Issue 6(Suppl) J Chromatogr Sep Tech
ISSN: 2157-7064 JCGST, an open access journal
Page 51
Notes:
Separation Techniques 2016
September 26-28, 2016
conferenceseries.com
Separation Techniques
September 26-28, 2016 Valencia, Spain
2nd International Conference and Expo on
Next generation clarification for processing high density cell culture fluids supplemented with a
flocculating agent
Sladjana Tomic Skrbic
Merck KGaA, Germany
The first step in the purification of a therapeutic product is clarification that typically combines multiple separation
technologies such as centrifugation, tangential flow microfiltration and depth filtration. Recent advances in mammalian
expression systems have led not only to very high cell density cultures and increased protein titers, but also for low viability
feed streams with high proportion of solid fraction that made those techniques less attractive. Complexity and issues at scale-
up limits the use of the centrifugation, while clarification of such high density cell harvests solely by depth filtration can be
costly due to high filter areas required. In this study, we present a complete clarification solution that combines cell harvest
pretreatment with a polycationic flocculating agent (pDADMAC), followed by depth filtration using enhanced depth filters
that were specifically developed for filtration of flocculated or precipitated feed streams. Multiple antibody feed streams have
been treated with pDADMAC and filtered using Clarisolve depth filters resulting in improved removal of cells and cell debris,
efficient reduction of DNA and high process yield. Overall, this innovative clarification approach leads to reduced filter area,
enhanced impurity removal and process simplification of high density cell harvests that can be readily incorporated into
current clarification platforms.
Biography
Sladjana Tomic Skrbic has studied Biotechnology at Beuth University of Applied Sciences, Berlin, Germany and completed her PhD at Max-Planck-Institute of
Biochemistry, Germany and Heidelberg University, Germany. She was a Post-doc at the Martin Luther University Halle-Wittenberg, Germany. Presently she is a
Senior Process Development Scientist at Merck KGaA in Darmstadt, Germany, where she provides high quality scientific and technical support to Merck customers
developing or manufacturing biopharmaceuticals. She also publishes and presents at conferences on bioprocess technologies.
Sladjana Tomic Skrbic, J Chromatogr Sep Tech 2016, 7:6(Suppl)