Activity measurements of dalcinonacog alfa.

Haemophilia : the Official Journal of the World Federation of Hemophilia
Stella C Williams, Elaine Gray

Abstract

Many recombinant and modified FIX products have been, and continue to be, developed with the aim of improving treatment for patients with haemophilia B. One such new product is dalcinonacog alfa, a recombinant FIX with modifications to provide improved features such as subcutaneous administration. In view of previously observed assay discrepancies with modified FIX therapeutics, the aim of this study was to assess potential discrepancies in potency measurement of dalcinonacog alfa between and within different assay methods. Potency of dalcinonacog alfa was measured against the 5th International Standard (IS) for FIX Concentrate and the 4th IS for FIX Plasma by One-Stage Clotting Assay, using 9 different APTT reagents and 2 commercially available FIX chromogenic kits. Plasma-derived concentrate and recombinant FIX samples were also included for comparison in every assay. Substantial discrepancies were observed when assaying dalcinonacog alfa using the one-stage clotting assay against both standards. No statistically valid results were obtained when testing dalcinonacog alfa using either chromogenic kit. Increasing the incubation time with the activation reagent in both chromogenic kits resulted in valid assays and increased the ...Continue Reading

References

Jun 30, 2010·Haemophilia : the Official Journal of the World Federation of Hemophilia·T W Barrowcliffe
Jun 29, 2012·Haemophilia : the Official Journal of the World Federation of Hemophilia·T W BarrowcliffeS Kitchen
Sep 18, 2012·International Journal of Laboratory Hematology·I MackieUNKNOWN British Committee for Standards in Haematology
Feb 15, 2013·Journal of Thrombosis and Haemostasis : JTH·A R HubbardUNKNOWN Factor VI I I and Factor IX Subcommittee of The Scientific and Standardisation Committee of The International Society on Thr
Apr 26, 2014·Haemophilia : the Official Journal of the World Federation of Hemophilia·S KitchenK Mertens
May 8, 2014·Haemophilia : the Official Journal of the World Federation of Hemophilia·H V WilmotE Gray
Jan 28, 2015·Haemophilia : the Official Journal of the World Federation of Hemophilia·J DodtG Silvester
Jul 14, 2016·Haemophilia : the Official Journal of the World Federation of Hemophilia·S KitchenS Tiefenbacher
Mar 7, 2017·Seminars in Thrombosis and Hemostasis·Steve KitchenRobert Gosselin
Mar 1, 2018·Haemophilia : the Official Journal of the World Federation of Hemophilia·G W KershawT-L Khoo
Jul 27, 2018·Research and Practice in Thrombosis and Haemostasis·Egon Persson, Carsten La Cour Christoffersen
Jul 28, 2018·Haemophilia : the Official Journal of the World Federation of Hemophilia·Helen V Wilmot, Elaine Gray
Dec 12, 2018·International Journal of Laboratory Hematology·Annette E BowyerMike Makris
Jan 23, 2019·Journal of Thrombosis and Haemostasis : JTH·Guy A YoungUNKNOWN International Prophylaxis Study Group (IPSG)

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Citations

May 8, 2021·Haemophilia : the Official Journal of the World Federation of Hemophilia·Johnny MahlanguFrank Del Greco
Jun 20, 2021·Journal of Thrombosis and Haemostasis : JTH·Mikhail V OvanesovTimothy K Lee

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Methods Mentioned

BETA
ChA

Software Mentioned

Combistats
GraphPad
GraphPad Prism
Catalyst

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