Enhanced aggregate removal from bulk biologicals using ion exchange chromatography
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United States of America Patent
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Jan 23, 2001
Grant Date -
N/A
app pub date -
Oct 13, 1998
filing date -
Oct 14, 1997
priority date (Note) -
Expired
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Abstract
Disclosed are methods and processes for removing aggregates and other impurities from partially purified protein bulk product, in particular, from partially purified monoclonal antibody, using anion exchange chromatography. In such methods and processes, the pH of the sample is adjusted to be lower than the isoelectric point of the product, preferably by 0.2 logs, and the sample is passed through an ion exchange matrix which is equilibrated to bind the aggregates and host cell DNA as well as endotoxins in the sample.
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