Research Paper on Characterization of Recombinant Factor IX with a Primary Sequence Corresponding to the Threonine-148 Polymorph, IXINITY„ (Trenonacog Alfa)

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Title: Characterization of Recombinant Factor IX with a Primary Sequence Corresponding to the Threonine-148 Polymorph, IXINITY„ (Trenonacog Alfa)

Abstract: These studies aimed to thoroughly characterize IXINITY (trenonacog alfa [coagulation factor IX (recombinant)], the first recombinant FIX therapeutic corresponding to the threonine-148 (Thr-148) polymorph. Gel filtration, circular dichroism, and gel electrophoresis were used to assess purity and validate structure. The identification and quantification of post-translational modifications was done using mass spectrometry and chromatographic methods. Activity was measured as the capacity to activate factor X (FX) in a standard clotting assay, both with and without factor VIIIa (FVIIIa). A number of lots of testing produced identical results. On Coomassie-stained gels, trenonacog alfa migrated as a single band. Activity assays were normal and revealed 0.002 IU of activated factor IX (FIXa) per IU of FIX. The molecule underwent the proper structural change when it bound calcium ions and is >97% -carboxylated. Factor XIa (FXIa) was used to activate trenonacog alfa normally; once activated, it bound to FVIIIa and FXa. Antithrombin effectively inhibited it when it was activated to FIXa. The literature reports of good pharmacokinetic performance were consistent with the glycosylation patterns of plasma-derived FIX, which had sialic acid content. These studies have demonstrated the high purity of trenonacog alfa and its primary sequence and posttranslational modifications, which are in agreement with the typical Thr-148 polymorphism of plasma-derived FIX.

Paper Quality: SCOPUS / Web of Science Level Research Paper

Subject: Medicine

Sub Category: Hematology

Writer Experience: 20+ Years

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