CONCLUSION
The application of the STIC membrane adsorber enables an alternative polishing platform for monoclonal antibodies. An operating
window of STIC in a flowthrough mode has been established through the use of high throughput screening and optimization on
96-well plates in a relatively short time frame. Acceptable product recovery and efficient clearance of host cell proteins,
leached protein A, DNA, and high molecular weight species have been demonstrated on STIC Nano using four model proteins.
The possible implication of HMW removal through STIC has been addressed. This simple and efficient polishing step can be integrated
into current mAb production platforms.
ACKNOWLEDGMENTS
The authors would like to thank Greg Liebisch of the Cell Expression/Scale-up team for providing harvested cell culture fluid
used in this study. The authors also thank David Zhou, Dr. Yujing Yang and Dr. Uwe Gottschalk at Sartorius Stedim Biotech
for providing STIC 96-well plates and for helpful discussion.
Yun (Kenneth) Kang* is a principal scientist and head of the Purification Team in BioProcess Sciences; Stanley Ng is a principal research associate in BioProcess Sciences; Julia Lee is a senior research associate in BioProcess Sciences; Josaih Adaelu is a principal research associate in Process Development; Bo Qi is a director in Process Development; Kris Persaud is a director in BioProcess Sciences; Dale Ludwig is a vice president in BioProcess Sciences; and Paul Balderes is a director in BioProcess Sciences, all at ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, New York,
NY. *To whom correspondence should be addressed, yun.kang@imclone.com
.
PEER REVIEWED
Article submitted: Oct. 4, 2011.
Article accepted: Oct. 28 2011.
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