Provided herein are anti-Factor IX Padua binding constructs, e.g., antibodies and antigen-binding fragments thereof. Related polypeptides, conjugates and kits are also provided. The inventions may be used in methods of detecting Factor IX Padua in a sample.

Embodiments of the disclosure concern methods of determining the effectiveness of immune cells, such as T cells, with particular chimeric antigen receptors. In specific embodiments, a synapse between the CAR and the tumor antigen is measured for structure, signaling, and functionality by imaging. As such, the quality of the synapse is determined and positively correlates with effectiveness of the particular CAR immune cells.

The present invention provides methods of dosing Factor VIII or Factor IX chimeric and hybrid polypeptides. The present invention further provides high-sensitivity methods of quantifying an amount of activated FIX protein in a test sample.

Embodiments of the disclosure concern methods of determining the effectiveness of immune cells, such as T cells, with particular chimeric antigen receptors. In specific embodiments, a synapse between the CAR and the tumor antigen is measured for structure, signaling, and functionality by imaging. As such, the quality of the synapse is determined and positively correlates with effectiveness of the particular CAR immune cells.

The present invention relates to variants of factor IX (F.IX) or activated factor IX (F.IXa), wherein the variant is characterized in that it has clotting activity in absence of its cofactor. The present invention furthermore relates to variants of factor IX (F.IX) or activated factor IX (F.IXa), wherein the variant is characterized in that it has increased F.IX clotting activity compared to wildtype. The present invention furthermore relates to the use of these variants for the treatment and/or prophylaxis of bleeding disorders, in particular hemophilia A and/or hemophilia B or hemophilia caused or complicated by inhibitory antibodies to F.VIII. The present invention also relates to further variants of factor IX (F.IX) which have desired properties and can, thus be tailored for respective specific therapeutic applications.

The present invention relates to variants of factor IX (F.IX) or activated factor IX (F.IXa), wherein the variant is characterized in that it has clotting activity in absence of its cofactor. The present invention furthermore relates to variants of factor IX (F.IX) or activated factor IX (F.IXa), wherein the variant is characterized in that it has increased F.IX clotting activity compared to wildtype. The present invention furthermore relates to the use of these variants for the treatment and/or prophylaxis of bleeding disorders, in particular hemophilia A and/or hemophilia B or hemophilia caused or complicated by inhibitory antibodies to F.VIII. The present invention also relates to further variants of factor IX (F.IX) which have desired properties and can, thus be tailored for respective specific therapeutic applications.

Provided is a blood coagulation reaction analysis method. The method includes measuring a blood coagulation reaction of a subject specimen and acquiring first data for calculating a blood coagulation time of the subject specimen and second data for estimating a blood coagulation abnormality factor of the subject specimen, wherein the acquiring of the second data includes: obtaining a first derivative V(i) of a coagulation reaction curve R(i); and determining a point p.sub.k where V(i) assumes X.sub.k before reaching a maximum value of V(i), Vmax, and a point q.sub.k where V(i) assumes X.sub.k after reaching Vmax.

Provided herein are anti-Factor IX Padua binding constructs, e.g., antibodies and antigen-binding fragments thereof. Related polypeptides, conjugates and kits are also provided. The inventions may be used in methods of detecting Factor IX Padua in a sample.

Provided herein are anti-Factor IX Padua binding constructs, e.g., antibodies and antigen-binding fragments thereof. Related polypeptides, conjugates and kits are also provided. The inventions may be used in methods of detecting Factor IX Padua in a sample.

The present disclosure provides methods and compositions for diagnosing and treating subject having a bleeding disorder. The disclosed methods comprise contacting a sample, e.g., a blood or plasma sample obtained from the patient, with an activation mixture comprising an activated coagulation factor and a phospholipid mixture, wherein the activation mixture is dried onto a solid substrate. Also provided is a global hemostasis test based on the integration of clotting time (Ct) and pharmacokinetics data. The methods and compositions presented can be applied to point-of-care diagnostic systems.