References

We continuously participate in research studies and collaborations. It’s important for us to contribute to increased knowledge and deeper understanding of hemostasis assay methodology. Please find below a selection of publications related to our products.

Scientific publications

Rox Factor IX

Lengler JK, Coulibaly S, Gruber B, Hoellriegl W, Falkner FG, Rottensteiner HP. Development of an In Vitro biopotency assay for an AAV8 hemophilia B gene therapy vector suitable for clinical product release. Mol Therapy Methods & Clin Development 2020. Open access

Williams SC, Gray E. Activity measurements of dalcinonacog alfa. Haemophilia 2020; 26 (2): 346-353.

Rosén S, Bryngelhed P. FIX potency of rFIX-Albumin fusion protein is underestimated by one-stage methods using silica-based APTT reagents. Haemophilia 2020; 26 (2): 340-345.

Ettingshausen CE, Hegemann L, Simpson ML, Cuker A, Kulkarni R, Garly M-L, Meldgaard RM, Persson P, Klamroth R. Favourable pharmacokinetics in hemophilia B for nonacog beta pegol versus recombinant FIX-Fc fusion protein: A randomised trial. Res Practice Thromb Haemost 2019; 3 (2): 268-276.

Kershaw GW, Dissanayake K, Chen VM, Khoo T-L. Evaluation of chromogenic factor IX assays by automated protocols. Haemophilia 2018; 24 (3): 492-501.

Tiefenbacher S, Bohra R, Amiral J, Bowyer A, Kitchen S, Lochu A, Rosen S, Ezban M. Qualification of a select one-stageactivated partial thromboplastin time-based clotting assay and two chromogenic assays for the post-administration monitoring of nonacog betapegol. J Thromb Haemost 2017; 15: 1901–12. Open access

DeRosa F, Guild B, Karve S, Smith L, Love K, Dorkin JR, Kaufmann KJ, Zhang J, Yahalom B, Anderson DG, Heartlein MW. Therapeutic efficacy in a hemophilia B model using a biosynthetic mRNA liver depot system. Nature Gene Therapy 2016; 23: 699-707.

Rosén P, Rosén S, Ezban M, Persson E. Overestimation of N-glycoPEGylated factor IX activity in a one-stage factor IX clotting assay owing to silica-mediated premature conversion to activated factor IX. J Thromb Haemost 2016; 14 (7): 1420-1427. Open access

Bowyer AE, Hillarp A, Ezban M, Persson P, Kitchen S. Measuring factor IX activity of nonacog beta pegol with commercially available one-stage-clotting and chromogenic assay kits: A two-center study. J Thromb Haemost 2016; 14 (7): 1428-1435.

Gray E, Hogwood J, Dougall T, Rigsby P. Collaborate study report on blood coagulation factor IX. Value assignment of the 5th International Standard for Blood Coagulation Factor IX Concentrate and the 3rd Ph Eur BRP for human Factor IX Concentrate. WHO 2015; WHO/BS/2015.2261: 1-70.

Rox FIX-A

Turecek P L et al. Nonacog gamma, a novel recombinant factor IX with low factor IXa content for treatment and prophylaxis of bleeding episodes. Expert Review of Clinical Pharmacology, March 2015; 8 (2): 163 – 177.

Schrenk G et al. Baxter Innovations GmbH, Vienna, Austria. Does the factor IXa content of factor IX products impact function, safety and efficacy. Poster Presented at the Bari International Conference (8th BIC) 2014 in Bari, Italy, Oct 3-5.

​Wilmot HV, Hogwood J, Gray E. Recombinant factor IX: discrepancies between one-stage clotting and chromogenic assays. Haemophilia 2014; 20: 891-897.

Böhm E, Dockal M, Pilz J, Schrenk G, Varadi K, Scheillinger F. Superiority of the chromogenic assay specific for activated factor IX (FIXa) over the non-activated partial thromboplastin time (NAPTT) clotting assay in detecting FIXa in recombinant FIX (rFIX) preparations. XXIV ISTH Congress 2013; Poster PB1.39-6.

Rox Factor XIa

Alonso W, Vandeberg P, Lang J, Yuziuk J, Silverstein R, Stokes K, McBride D, Cruz M, Burns D, Merritt WK, Willis T, Jorquera JI. Immune globulin subcutaneous, human 20% solution (Xembify®), a new high concentration immunoglobulin product for subcutaneous administration. Biologicals 2020; 64: 34-40. Open access

Persson E, Foscolo T, Hansen M. Reagent- specific underestimation of turoctocog alfa pegol (N8- GP) clotting activity owing to decelerated activation by thrombin. Res Pract Thromb Haemost. 2019; 3: 114–120. Open access

Stroo I, Marquart JA, Bakhtiari K, Plug T, Meijer AB, Meijers JCM. Chemical Footprinting Reveals Conformational Changes Following Activation of Factor XI. Thromb Haemost 2018; 118(02): 340-350.

Rosén S. New Tools to Study Contact Activation. Front. Med. 2016; 3: 58. Open access

Park DH, Kang GB, Kang DE, Hong JW, Lee MG, Kim KY, Han JW. A new manufacturing process to remove thrombogenic factors (II, VII, IX, X and XI) from intravenous immunoglobulin gamma preparations. Biologicals 2016. Open access

Rosén P, Rosén S, Ezban M, Persson E. Overestimation of N-glycoPEGylated factor IX activity in a one-stage factor IX clotting assay owing to silica-mediated premature conversion to activated factor IX. J Thromb Haemost 2016; 14 (7): 1420-1427. Open access

Hansson KM, Nielsen S, Elg M, Deinum J. The effect of corn trypsin inhibitor and inhibiting antibodies for FXIa and FXIIaon coagulation of plasma and whole blood. J Thromb Haemost 2014; 12: 1678–86. Open access

Persson E, Foscolo T, Hansen M. Reagent- specific underestimation of turoctocog alfa pegol (N8- GP) clotting activity owing to decelerated activation by thrombin. Res Pract Thromb Haemost. 2019; 3: 114–120. Open access

Rox Factor VIII

Bryngelhed P, Rosén P. Characterization of a new chromogenic Factor VIII assay containing human FIXa and bovine FX. 13th EAHAD 2020; Poster P021. Download

Rox Prothrombin

Lövgren A. Recombinant snake venom prothrombin activators. Bioengineered  2013; 4 (3): 153-157.

Brenden N, Madeyski-Bengtson K, Martinsson K, Svärd R, Albery-Larsdotter S, Granath B, Lundgren H, Lövgren A. A triple-transgenic immunotolerant mouse model. J Pharm Sci  2013; 102 (3): 1116-1124.

Phospholipid, Phospholipid-TGT

Biltoft D, Gram JB, Larsen A, Münster A-MB, Sidelmann JJ, Skjödt K, Palarasah Y. Fast form alpha-2-macroglobulin: A marker for protease activation in plasma exposed to artificial surfaces.  Clin Biochem 2017; 50 (18): 1203-1218.

Lövgren A, Deinum J, Rosén S, Bryngelhed P, Rosén P, Hansson KM. Characterization of thrombin derived from human recombinant prothrombin. Blood Coagul Fibrinol 2015; 26 (5): 545-555.

Pahl S, Pavlova A, Driesen J, Müller J, Pötzsch B, Oldenburg J. In vitro charcácterization of recombinant factor VIII concentrates reveals significant differences in protein content, activity and thrombin activation profile. Haemophilia 2013; 19 (3): 392-398.

Sandberg H, Kannicht C, Stenlund P, Dadaian M, Oswaldsson U, Cordula C, Walter O. Functional characteristics of the novel, human-derived recombinant FVIII protein product, human-cl rhFVIII. Thromb Res 2012; 130 (5): 808-817.

Shibeko AM, Woodle SA, Lee TK, Ovanesov MV. Unifying the mechanism of recombinant FVIIa action: Dose dependence is regulated differently by tissue factor and phospholipids. Blood 2012; 120 (4):891-899.

Loof TG, Mörgelin M, Johansson L, Oemche S, Olin AI, Dickneite G, Norrby-Teglund A, Theopold U, Herwald H. Coagulation, an ancestral serine protease cascade, exerts a novel function in early immune defence. Blood 2011; 118 (9): 2589-2598.

Blombäck M, He S, Bark N, Wallén HN, Elg M. Effect of fibrin network porosity of anticoagulants with different modes of action and reversal by activated coagulation factor concentrate. Br J Haematol 2011; 152 (6): 758-765.

Winckers K, Siegerink B, Duckers C, Maurissen LF, Tans GT, Castoldi E, Spronk HMH, ten Cate H, Algra A, Hackeng TM, Rosendaal FR. Increased tissue factor pathway inhibitor activity is associated with myocardial infarction in young women: Results from the RATIO study. J Thromb Haemost 2011; 9 (11): 2243-2250.

Duckers C, Simioni P, Spiezia L, Radu C, Dabrilli P, Gavasso S, Rosing J, Castoldi E. Residual platelet factor V ensures thrombin generation in patients with severe congenital factor V deficiency and mild bleeding symptoms. Blood 2010; 115 (4):879-888.

Devreese K, Peerlinck K, Arnouit J, Hoylaerts M. Laboratory detection of the antiphospholipid syndrome via calibrated automated thrombography. Thromb Haemost 2009; 101 (1):185-196.

Gardiner C, Machin SJ, Mackie IJ. Measuring thrombin generation based sensitivity to activated protein C using an automated coagulometer (ACL 9000). Int J Lab Hematol 2008; 30 (4); 261-268.