2023
DOI: 10.3389/fcvm.2023.1253177
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Cation exchange chromatography removes FXIa from a 10% intravenous immunoglobulin preparation

Gil Bu Kang,
Alan Huber,
Jihye Lee
et al.

Abstract: The presence of residual activated coagulation factor XI (FXIa) in some commercial intravenous immunoglobulin (IVIG) products has been identified as the root cause of a small number of thromboembolic events in patients who had received such therapy. Our objectives here were to design and evaluate the manufacturing process of GC5107, a 10% glycine-stabilized IVIG product, for its capacity to remove FXIa. The manufacturing process included a cation exchange chromatography (CEX) step, which employs a resin that b… Show more

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