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US 12,274,738 B2Granted
FX activation process and its use in the preparation of a FXa composition
AssigneeOctapharma AG
InventorsJuergen Roland Roemisch, Katharina Pock, Petra Schulz, Silvio Wuschko, Michael Andesner, Andrej Muranyi
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Abstract
The invention relates to a high purity Coagulation Factor Xa (FXa or activated Coagulation Factor X) preparation and an activation and purification process to obtain said FXa of high purity and high degree of activation without addition of proteinaceous activators during manufacturing.
Claims20
A process for activating Coagulation Factor X (FX) to activated Coagulation Factor X (FXa), wherein the process is performed in vitro and comprises the following steps:
- a. providing a composition containing FX and FII;
- and
- b. contacting said composition with phosphatidylserine (PS) and calcium to form an activation composition;
- and
- c. incubating the activation composition to allow a conversion from FX to FXa, wherein the yield of conversion from FX to FXa is in the range of 20%-100%, and
- wherein before, during and after incubation no proteinaceous activator is added to the composition(s).
3 more elements
Dependencies are inferred from the claim text.