Abstract: Among other aspects, the present invention relates to cell culture conditions for producing high molecular weight vWF, in particular, highly multimericWF with a high specific activity and ADAMTS13 with a high specific activity. The cell culture conditions of the present invention can include, for example, a cell culture medium with an increased copper concentration and/or cell culture supernatant with a low ammonium (NH4+) concentration. The present invention also provides methods for cultivating cells in the cell culture conditions to express high molecular weight vWF and rA13 having high specific activities.

Abstract: A method of using a device for encouraging adherence to a medication schedule and proper administration technique includes placing the device on a surface. The device includes a body, a timer associated with the body for measuring and displaying an elapsed time since an immediately prior medication dose was administered; and a button on the body that, when depressed relative to the body, resets the timer. The button is sized and shaped for accommodating a medication container used to store or activate the medication. The button and the body are configured for cooperating with the medication container for facilitating mixing of the medication. The method further includes engaging the medication container with the button and resetting the timer.

Abstract: The invention provides peptides, including peptides that bind and, optionally, inhibit Protein S, and compositions thereof. The peptides may be used to, e.g., inhibit Protein S activity, enhance thrombin formation in a subject, increase blood clot formation in a subject, treat a blood coagulation disorder in a subject, purify Protein S, and identify a Protein S binding compound.

Abstract: The present invention provides culture mediums that are useful for the expression of ADAMTS proteins, such as ADAMTS13. Methods for the expression and purification of ADAMTS proteins are also provided. In some embodiments, the mediums and methods of the invention are useful for the expression of ADAMTS proteins having high specific activities. Also provided are ADAMTS, e.g., ADAMTS13, protein compositions with high specific activities, which are expressed and purified according to the methods provided herein.

Abstract: Aspects of the invention include methods for identifying one or more NASP (non-anticoagulant sulfated polysaccharide) compositions that are suitable for treating a subject having a blood coagulation disorder. In practicing methods according to certain embodiments, NASP compositions are evaluated by determining the coagulation activity and chemical makeup of the NASP composition and the molecular structure of the NASP. Systems for practicing methods of the invention as well as compositions suitable for treating a subject having a blood coagulation disorder are also described.

Abstract: Among other aspects, the present invention relates to cell culture conditions for producing high molecular weight vWF, in particular, highly multimeric WF with a high specific activity and ADAMTS13 with a high specific activity. The cell culture conditions of the present invention can include, for example, a cell culture medium with an increased copper concentration and/or cell culture supernatant with a low ammonium (NH4+) concentration. The present invention also provides methods for cultivating cells in the cell culture conditions to express high molecular weight vWF and rA13 having high specific activities.

Abstract: The present invention provides methods for reducing the amidolytic and anti-complement activity (ACA) content of an immunoglobulin composition through the use of cation exchange chromatography. In a specific embodiment, the invention provides methods for reducing the Factor XI and/or Factor XIa and/or ACA content of an immunoglobulin composition by collecting the leading portion of a cation exchange eluate. The present invention also provides immunoglobulin composition having reduced levels of amidolytic activity, Factor XI, and/or Factor XIa, and/or ACA content.

Abstract: The present invention relates to a method for determining the highest temperature that is suitable for performing accelerated protein stability studies, as well as to a method for modeling real-time protein stability from accelerated stability data generated at said temperature.

Abstract: A reconstitution assembly includes a housing including a lower sleeve and an upper sleeve, including a first container and a second container disposed vertically opposite the first container. A transfer set assembly is disposed within the housing between the first container and the second container. The transfer set assembly includes an upper spike housing and a lower spike housing, with a flow path defined through the upper spike housing and the lower spike housing. The transfer set assembly is configured to access contents of the first container and then upon the activation of a triggering mechanism, create a fluid pathway between the first container and the second container. The triggering mechanism ensures the transfer set assembly sequentially accesses the contents of the first container before accessing the contents of the second container. The disposition of the first container activates the triggering mechanism.

Abstract: Culturing heterologous protein-secreting mammalian cells, such as CHO or BHK cells, at 35.1-36.5° C. and/or at pH 7.15-7.20 and/or at a dissolved CO2 concentration of 10% or lower. Preferred heterologous proteins are Factor VIII, ADAMTS-13, furin or Factor VII.

Abstract: The present invention relates to formulations of ADAMTS13 with enhanced or desirable properties. As such, the invention provides liquid and lyophilized formulations of ADAMTS13 that are suitable for pharmaceutical administration. Among other aspects, the present invention also provides methods of treating various diseases and conditions related to VWF and/or ADAMTS13 dysfunction in a subject. Also provided herein are kits comprising ADAMTS13 formulations useful for the treatment of various diseases and conditions.

Abstract: A Factor VIII composition formulated without albumin, comprising the following formulation excipients in addition to Factor VIII: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8.

Abstract: The invention relates to the development of chimeric OspA molecules for use in a new Lyme vaccine. More specifically, the chimeric OspA molecules comprise the proximal portion from one OspA serotype, together with the distal portion from another OspA serotype, while retaining antigenic properties of both of the parent polypeptides. The chimeric OspA molecules are delivered alone or in combination to provide protection against a variety of Borrelia genospecies. The invention also provides methods for administering the chimeric OspA molecules to a subject in the prevention and treatment of Lyme disease or borreliosis.

Abstract: The present invention provides methods for purifying Von Willebrand factor (VWF) for increased removal of non-lipid enveloped viruses.

Abstract: The invention relates to vWF cleaving entities having a molecular weight of 180 kD, 170 kD, 160 kD, 120 kD or 110 kD and an N-terminal amino acid sequence of AAGGILHLELLV, vWF cleaving complexes and methods for their production.

Abstract: The invention relates to the development of chimeric OspA molecules for use in a new Lyme vaccine. More specifically, the chimeric OspA molecules comprise the proximal portion from one OspA serotype, together with the distal portion from another OspA serotype, while retaining antigenic properties of both of the parent polypeptides. The chimeric OspA molecules are delivered alone or in combination to provide protection against a variety of Borrelia genospecies. The invention also provides methods for administering the chimeric OspA molecules to a subject in the prevention and treatment of Lyme disease or borreliosis.

Abstract: The present invention provides methods of treating coagulation disease, including hemophilia and von Willebrand disease by administering recombinant von Willebrand Factor alone or in combination with Factor VIII.

Abstract: The invention relates to the development of in vitro assay systems that force the release of a water-soluble polymer, such as polyethylene glycol (PEG) and polysialic acid (PSA), from proteins modified with a reversibly-linked water-soluble polymer. The invention includes methods for analyzing the release of the water-soluble polymer and measuring regained protein activity. The invention further includes methods appropriate for the quality control of proteins modified with releasable water-soluble polymers, including polymers like PEG and PSA.

Abstract: Aspects of the invention include methods for treating or preventing a thromboembolic disease in a subject. In practicing methods according to certain embodiments, an amount of a low molecular weight heparin (LMWH) and a synergistically effective combination of two or more gastrointestinal epithelial barrier permeation enhancers is orally administered to a subject in a manner sufficient to treat the thromboembolic disease in the subject. Compositions and kits for practicing methods of the invention are also described.

Abstract: The present invention provides a method for preventing or inhibiting allograft rejection by a recipient of that allograft by treating the recipient with a composition comprising Factor H (FH). The invention also encompasses methods in which the recipient is also administered one or more immunosuppressants in addition to the Factor H.