2020
DOI: 10.1016/j.biologicals.2020.07.009
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Summary of the WHO hearing on the development of product-specific reference materials for coagulation factor VIII and factor IX products

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Cited by 3 publications
(25 citation statements)
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“…One should keep in mind that, in contrast to TGA, some very common routine assays such as aPTT which are considered to give reliable readouts equally lack standardization 62 . Also, issues related to consistently and reliably measure coagulation factors VIII and IX have been subject to scientific debates over the last 20+ years and now more than ever are continuously discussed by scientific boards and drug regulatory agencies (e.g 63‐65 …”
Section: Discussionmentioning
confidence: 99%
“…One should keep in mind that, in contrast to TGA, some very common routine assays such as aPTT which are considered to give reliable readouts equally lack standardization 62 . Also, issues related to consistently and reliably measure coagulation factors VIII and IX have been subject to scientific debates over the last 20+ years and now more than ever are continuously discussed by scientific boards and drug regulatory agencies (e.g 63‐65 …”
Section: Discussionmentioning
confidence: 99%
“…15 Indeed, traceability of product unitage to a single plasma IS should not be construed to mean biological or biochemical equivalency between the factor protein in normal plasma and the protein in the recombinant or plasma-derived factor concentrates. 11 By design, the manufacturing processes for plasma-derived and recombinant proteins select for a more homogenous distribution of protein isoforms (e.g., by removing protein variants with different charges, sizes, or binding properties than the desired protein product). At the same time, certain manufacturing steps may inadvertently modify the protein (e.g., viral inactivation treatment).…”
Section: Role Of the Internati Onal S Tandardmentioning
confidence: 99%
“…[44][45][46][47][48][49][50] It remains a challenge for all stakeholders to reconcile the assay results and resolve this situation. 11…”
Section: A Ssay D Iscrepan Cie S For Con Centr Ate S Of F Viii and Fixmentioning
confidence: 99%
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