Monitoring of different factor VIII replacement products using a factor VIII one‐stage clotting assay on cobas t 511/711 analysers

Introduction Recombinant coagulation factor VIII (FVIII) products are the standard of care for patients with haemophilia A. The development of modified FVIII products has provided benefit for patients but presented challenges for monitoring FVIII activity. Aim This single‐centre study evaluated the...

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Bibliographic Details
Published in:Haemophilia : the official journal of the World Federation of Hemophilia 2021-11, Vol.27 (6), p.e704-e712
Main Authors: Ketteler, Carolin, Hoffmann, Ingrid, Davidson, Simon, Tiede, Andreas, Richter, Nina
Format: Article
Language:English
Subjects:
activated partial thromboplastin time
biological assay
Blood Coagulation Tests
Clotting
Coagulation factor VIII
Coagulation factors
drug monitoring
Factor VIII
Fc receptors
Fusion protein
haemophilia A
Hemophilia
Hemophilia A - drug therapy
Hemostatics
Humans
Original
recombinant fusion proteins
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Summary:Introduction Recombinant coagulation factor VIII (FVIII) products are the standard of care for patients with haemophilia A. The development of modified FVIII products has provided benefit for patients but presented challenges for monitoring FVIII activity. Aim This single‐centre study evaluated the Roche FVIII one‐stage clotting assay (OSA) in measuring FVIII activity in plasma samples spiked with seven FVIII products at clinically relevant concentrations. Methods FVIII‐deficient plasma samples were spiked with two batches of recombinant FVIII products (octocog alfa, moroctocog alfa, simoctocog alfa, efmoroctocog alfa, damoctocog alfa pegol, rurioctocog alfa pegol, lonoctocog alfa) at 1–120 IU/dL FVIII activity, according to their labelled potency. Measurement was conducted on the cobas t 511/711 analysers using the Roche FVIII OSA and the Technoclone TECHNOCHROM FVIII:C chromogenic substrate assay (CSA). Results Using the OSA, FVIII activity was close to labelled potency for most analysed FVIII products including a recombinant FVIII Fc fusion protein. PEGylated FVIII product, damoctocog alfa pegol, was marginally above and single‐chain product, lonoctocog alfa, below the predefined acceptance criteria: for FVIII activity 
ISSN:1351-8216
1365-2516
DOI:10.1111/hae.14416