Abstract: Low-viscosity nucleic acid compositions that can be administered by oral or multiple parenteral routes may allow for less frequent dosing than nucleic acid products currently on the market. In particular, low-viscosity defibrotide formulations for subcutaneous, intramuscular, intradermal, and intraperitoneal administration are more convenient to the patient and/or are administered outside of the hospital setting. Formulations of the invention may be used for the treatment of numerous conditions including for example, treatment of peripheral arteriopathies, treatment of acute renal insufficiency, treatment of acute myocardial ischemia, and treatment and prevention of sinusoidal obstruction syndrome or VOD.

Abstract: Systems and methods for preparing a therapeutic protein solution, reducing its viscosity, and administering it to a subject are provided herein. Methods provided herein are particularly useful for preparing a therapeutically effective concentration of Neublastin for subject administration.

Abstract: The present disclosure provides high concentration low viscosity defibrotide formulations administered via an automated injection device. The device is calibrated for optimum flow rate and administration of the high concentration low viscosity formulation.

Abstract: Low-viscosity, high concentration nucleic acid compositions that can be administered by multiple parenteral routes may allow for less frequent dosing than nucleic acid products currently on the market. In particular, low-viscosity defibrotide formulations for subcutaneous, intramuscular, and intraperitoneal administration are more convenient to the patient and/or are administered outside of the hospital setting. Formulations of the invention may be used for the treatment of numerous conditions including for example, treatment of peripheral arteriopathies, treatment of acute renal insufficiency, treatment of acute myocardial ischemia, and treatment and prevention of sinusoidal obstruction syndrome or VOD.

Abstract: Low-viscosity, high concentration nucleic acid compositions that can be administered by multiple parenteral routes may allow for less frequent dosing than nucleic acid products currently on the market. In particular, low-viscosity defibrotide formulations for subcutaneous, intramuscular, and intraperitoneal administration are more convenient to the patient and/or are administered outside of the hospital setting. Formulations of the invention may be used for the treatment of numerous conditions including for example, treatment of peripheral arteriopathies, treatment of acute renal insufficiency, treatment of acute myocardial ischemia, and treatment and prevention of sinusoidal obstruction syndrome or VOD.

Abstract: Provided herein, in some aspects, are methods of developing a biological therapeutic product. The methods can be used to formulate a biological therapeutic agent or screen biological therapeutic agents.

Abstract: Systems and methods for preparing a therapeutic protein solution, reducing its viscosity, and administering it to a subject are provided herein. Methods provided herein are particularly useful for preparing a therapeutically effective concentration of Neublastin for subject administration.

Abstract: The present invention relates to a stable, low viscosity antibody formulation, wherein the formulation comprises a high concentration of anti-IL6 antibody. In some embodiments, the invention is directed to a stable, low viscosity antibody formulation comprising about 50 mg/mL to about 400 mg/mL of an anti-IL6 antibody, and arginine, wherein the antibody formulation is in an aqueous solution and has a viscosity of less than 20 cP at 23° C. Also provided are methods of making and methods of using such antibody formulations.