Abstract: A method of quantitating free (unbound) human C5 complement protein (C5) from a sample comprising: binding biotinylated anti-C5 capture antibody to strepavidin-coated particles; capturing the free (unbound) C5 in the sample; detecting the captured free C5; and quantitating the captured free C5 using laser-induced fluorescence detection; wherein the method is performed in a Gyros Bioaffy 200 CD in a Gyrolab xPlore or a Gyrolab XP instrument.

Abstract: This disclosure relates to novel formulations of bis-choline tetrathiomolybdate useful for treating a copper metabolism-associated disease or disorder, such as Wilson disease (WD). For example, this disclosure relates to low dose formulations of bis-choline tetrathiomolybdate.

Abstract: Provided are methods for clinical treatment of complement-mediated TMA (CM-TMA) (e.g., CM-TMA associated with a trigger, such as autoimmune condition, an infection, a transplant, one or more drugs, or malignant hypertension), using an anti-C5 antibody, or antigen binding fragment thereof, such as ravulizumab (ULTOMIRIS®).

Abstract: Provided herein are methods of performing viral filtration on a fluid including a recombinant antibody, and the use of these methods in methods of manufacturing or producing the recombinant antibody.

Abstract: Provided herein are high throughput methods for measuring the protease activity of the complement C3 convertase by detecting the consumption of C3 or the production of C3a in vivo and in vitro.

Abstract: A method of producing recombinant alkaline phosphatase comprising control of production parameters, particularly harvest clarified culture fluid (HCCF) and filtration pool (UFDF), to provide a defined total sialic acid content.

Abstract: Featured are methods of manufacturing recombinant alkaline phosphatases, such as asfotase alfa, that provide more precise quality control over total sialic acid content (TSAC) concentration in the final product by measuring TSAC concentration during fermentation and adjusting downstream production steps in response.

Abstract: Provided herein are antibodies which bind to ceruloplasmin and are useful for various applications, including detecting ceruloplasmin and immunocapturing ceruloplasmin in biological samples. The antibodies are useful in methods of measuring non-ceruloplasmin-bound copper concentrations and labile-bound copper concentrations in biological samples.

Abstract: Provided herein are methods of treatment designed to prevent or minimize formation of deleterious multivalent immune complexes in a human patient having a complement mediated disorder (e.g., paroxysmal nocturnal hemoglobinuria (PNH) or atypical hemolytic uremic syndrome (aHUS)), who has been or is being treated with a first anti-C5 antibody and is then treated with a second (different) anti-C5 antibody, as well as methods of safely switching a patient from treatment with a first anti-C5 antibody to a second (different) anti-C5 antibody. Also provided are methods for determining an adjusted regimen antibody (e.g., a regimen to prevent or minimize formation of multivalent immune complexes) comprising an adjusted therapeutic dose and/or timing of administration of a second anti-C5 to treat a patient who has been or is being treated with a first anti-C5 antibody.

Abstract: This disclosure relates to methods of diagnosing and treating a copper metabolism-associated disease or disorder, such as Wilson disease (WD).

Abstract: The present disclosure provides methods for manufacturing a fXa derivative protein at large scale leading to high yield of highly pure protein product. The method may include adding a detergent to a sample that contains a polynucleotide construct encoding the protein and purifying the protein through a soybean trypsin inhibitor (STI)-based affinity chromatograph, an ion exchange and mixed mode chromatograph and a hydrophobic interaction.

Abstract: The present invention relates antidotes to anticoagulants targeting factor Xa. The antidotes are factor Xa protein derivatives that bind to the factor Xa inhibitors thereby substantially neutralizing them but do not assemble into the prothrombinase complex. The derivatives describe herein lack or have reduced intrinsic coagulant activity. Disclosed herein are methods of stopping or preventing bleeding in a patient that is currently undergoing anticoagulant therapy with a factor Xa inhibitor.

Abstract: A method of quantitating free (unbound) human C5a complement protein (C5a) from a sample comprising: binding biotinylated anti-C5a capture antibody to strepavidin-coated particles; capturing the free (unbound) C5 in the sample; detecting the captured free C5a; and quantitating the captured free C5 using laser-induced fluorescence detection; wherein the method is performed in a Gyros Bioaffy 200 CD in a Gyrolab xPlore or a Gyrolab XP instrument; wherein human C5 is first removed from the sample.

Abstract: Featured are compositions and methods for treating bone mineralization disorders, such as hypophosphatasia (HPP). In some embodiments, the methods described herein are useful for treating adult subjects with HPP and/or treating or preventing bone fractures.

Abstract: The disclosure provides methods of treating a subject having or suspected of having dermatomyositis using a composition including a bi-specific fusion protein. The composition may be administered using a medical device, such as a wearable injector.

Abstract: The present disclosure relates to, inter alia, compositions containing an inhibitor of human complement and use of the compositions in methods for treating or preventing complement-associated disorders. In some embodiments, the inhibitor is chronically administered to patients. In some embodiments, the inhibitor is administered to a patient in an amount and with a frequency to maintain systemic complement inhibition and prevent breakthrough. In some embodiments, the compositions contain an antibody, or antigen-binding fragment thereof, that binds to a human complement component C5 protein or a fragment of the protein such as C5a or C5b.

Abstract: The present disclosure provides methods and compositions useful for diagnosing and treating activated alternative pathway of complement in a human subject with a SARS-CoV-2 infection. Also provided are methods of treating an infection by a betacoronavirus, e.g., SARS-CoV, MERS-CoV, or SARS-CoV-2, in a human subject. The methods of treatment include administering to the human subject a therapeutically effective amount of at least one complement factor D inhibitor. Also provided herein are compounds for treating an infection by a betacoronavirus and their use in the manufacture in a medicament for treating an infection by a betacoronavirus.

Abstract: Provided are dosages and methods for clinical treatment of C5-mediated glomerular nephritis (GN), including lupus nephritis (LN) and immunoglobulin A nephropathy (IgAN), in human patients using an anti C5 antibody, or antigen binding fragment thereof (e.g., such as ravulizumab (ULTOMIRIS®)), optionally together with background therapy for treating LN (e.g., an immuno-suppressant) or background therapy for treating IgAN (e.g., renin-angiotensin system (RAS) inhibiting medication).

Abstract: Disclosed herein are methods of detecting complement activity in a biological sample. The disclosure also relates to methods for diagnosis or prognostic assessment of a complement-mediated disease in a subject and methods for monitoring response to treatment of a complement-mediated disease with a complement modulator in a subject.

Abstract: Provided herein are antibodies, or antigen binding portions thereof, that bind to CD200. Also provided are uses of these proteins in therapeutic applications, such as the treatment of cancer and in conjunction with organ transplantation. Also provided are nucleic acids encoding the heavy and/or light chain variable regions (or heavy and/or light chains) of the antibodies, vectors comprising the nucleic acids, and cells that produce the antibodies.