Abstract: Fusion proteins comprising an extracellular domain of PD1 (programmed cell death protein-1) protein and/or an extracellular domain of PD-L1 (programmed cell death-ligand 1 protein (CD274 or B7-H1)) protein. Portions of the extracellular domains are expressed in specific configurations and purified as protein and used in immunoassays to monitor the circulating levels of biotherapeutic antibodies to these proteins. Also described is a method of determining the amount of circulating levels of a biotherapeutic antibody in a biological sample obtained from a patient, wherein a patient has undergone at least one dose of immunotherapy.

Abstract: A composition that binds to an anti-CD38 antibody includes a specific sequence of a recombinant soluble form of an extracellular domain of CD38 and/or a fragment thereof that interferes with binding activity of the anti-CD38 antibody. The composition can be included in a kit for bio-monitoring research and diagnostic assays. The composition can be used to neutralize an anti-CD38 antibody in a sample and/or to select a suitable red blood cell unit for a patient treated with anti-CD38 antibodies.

Abstract: Various aspects of the invention relate to compositions and methods of analyzing blood plasma, blood serum, and manufacturing pools of plasma-derived products wherein an anionic surfactant is added to an aliquot of the blood plasma, blood serum, or manufacturing pool prior to analysis, and the counterion of the anionic surfactant is not sodium ion. The anionic surfactant may be, for example, lauryl sulfate. The counterion of the anionic surfactant may be, for example, lithium ion.

Abstract: Various aspects of the invention relate to recombinant polypeptides that specifically bind human von Willebrand Factor. Such recombinant polypeptides typically include a modified extracellular domain of platelet glycoprotein Ib? that typically comprises at least one mutation selected from G233T, D235V, and K237V, and such recombinant polypeptides optionally include an oligomerization domain.

Abstract: The invention relates to a device for determining a cellular-bound analyte in a liquid sample, comprising a separation matrix with at least one indicator zone. The invention is characterized in that the indicator zone comprises a first antibody directed against the cellular-bound analyte or a fragment thereof and a binding element directed against the first antibody, the first antibody being an incomplete antibody. The separation matrix is preferably designed in the form of the membrane of a lateral flow assay device or as a gel matrix. In a particularly preferable manner, the device comprises a membrane (2) with a charging zone (5) for applying the liquid sample, at least one indicator zone which can interact with the cellular-bound analyte, and at least one absorption region (3) which absorbs the liquid after passing the indicator zone. The indicator zone lies between the charging zone (5) and the absorption region (3).

Abstract: Novel mammalian expressed human immunodeficiency virus envelope Protein antigens Various embodiments of the invention relate to polypeptides comprising 1-10 or more epitopes of the HIV envelope protein and a fusion protein, wherein the polypeptide lacks the transmembrane domain of the HIV gp41 protein. Such polypeptides may be expressed in mammalian cells, such as human cells, to produce, for example, polypeptides that are useful in developing novel anti-HIV antibodies. Polypeptides described herein and novel antibodies developed therefrom are generally useful for medical diagnostics, and they may also be useful in the prophylactic and therapeutic treatment of HIV.

Abstract: Various aspects of the invention relate to compositions and methods of analyzing blood plasma, blood serum, and manufacturing pools of plasma-derived products wherein an anionic surfactant is added to an aliquot of the blood plasma, blood serum, or manufacturing pool prior to analysis, and the counterion of the anionic surfactant is not sodium ion. The anionic surfactant may be, for example, lauryl sulfate. The counterion of the anionic surfactant may be, for example, lithium ion.

Abstract: Fusion proteins comprising an extracellular domain of PD1 (programmed cell death protein-1) protein and/or an extracellular domain of PD-L1 (programmed cell death-ligand 1 protein (CD274 or B7-H1)) protein. Portions of the extracellular domains are expressed in specific configurations and purified as protein and used in immunoassays to monitor the circulating levels of biotherapeutic antibodies to these proteins. Also described is a method of determining the amount of circulating levels of a biotherapeutic antibody in a biological sample obtained from a patient, wherein a patient has undergone at least one dose of immunotherapy.

Abstract: The invention relates to a device for determining a cellular-bound analyte in a liquid sample, comprising a separation matrix with at least one indicator zone. The invention is characterized in that the indicator zone comprises a first antibody directed against the cellular-bound analyte or a fragment thereof and a binding element directed against the first antibody, the first antibody being an incomplete antibody. The separation matrix is preferably designed in the form of the membrane of a lateral flow assay device or as a gel matrix. In a particularly preferable manner, the device comprises a membrane (2) with a charging zone (5) for applying the liquid sample, at least one indicator zone which can interact with the cellular-bound analyte, and at least one absorption region (3) which absorbs the liquid after passing the indicator zone. The indicator zone lies between the charging zone (5) and the absorption region (3).