Conclusion
The novel approach of using a short, disk-like column with a resin capable of operating at high flow rates for AEX flow-through
polish chromatography delivers increased flexibility when designing a purification scheme. This format is ideal for rigid
resins with flow rate independent performance driven by the convective properties of the base bead. The properties of POROS
HQ, for example, drive increased throughput and smaller column sizes, and ultimately a column that can be sized based on capacity
for impurities. In addition, POROS HQ has been shown to have high impurity binding capacity and clearance over a range of
process conditions, including high conductivity conditions (data not shown). This decreases the need for dilution of the feed
stream or inclusion of a diafiltration step prior to loading on the HQ column, making the process more efficient and cost-effective.
If disposability is a factor, Life Technologies now offers Go-Pure Pre-Packed Chromatography Columns for maximum convenience,
providing faster time to process and faster time between processes.
This new approach to AEX FT polish chromatography increases process development flexibility and offers a more cost effective
approach to this process step as compared to improperly, oversized soft gel columns, and membranes with limited sizes and
expensive formats at larger scale. This study shows that a high performance AEX resin competes well with the performance of
membranes, providing similar processing times and the added benefits of reusability, which decreases material costs with increased
cycles as modeled in Table 4. In addition, ease of packing at different scales in various column formats and the ability to
implement initial process design from early phase manufacturing to commercial manufacturing reduces overall process development
costs and decreases time to market.
For Research Use Only. Not intended for animal or human therapeutic or diagnostic use.
Acknowledgments
The authors would like to thank Susanne Alexander, Roger Decker, and Elliot Haimes for assistance with the execution of these
studies.
SHELLY COTE PARRA, MS, is a senior field applications scientist in the POROS Applications group at Life Technologies, shelly.cote@lifetech.com
. CHRISTINE GEBSKI, MS, is the director of POROS R&D and Applications at Life Technologies, Bedford, MA, christine.gebski@lifetech.com
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