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.

The present invention provides an application of neuregulin protein in the preparation of drugs for preventing, treating or delaying human heart failure, and a use method of the drugs for preventing, treating or delaying human heart failure. The method comprises: testing a patient first before treatment, the testing comprises detecting the plasma level of NT-proBNP or BNP; and then providing appropriate treatment on the basis of the test result. When the test result is within an optimal treatment range, the patient is suitable for the treatment of heart failure by administering an effective dose of neuregulin.

Provided herein are methods for determining the functional status of a cellular pathway in a diseased cell sample obtained from an individual subject. These methods involve contacting a diseased cell sample obtained from the subject with a perturbing agent (e.g., an activating agent) known to perturb a specific cellular pathway when the pathway is functioning normally. A change in one or more physiological response parameters in the presence of the perturbing agent indicates that the cellular pathway targeted by the perturbing agent is functional in the individual subject. Methods of selecting a targeted therapeutic agent for an individual subject are also provided.

A diagnostic method for predicting quantitatively whether a human tumor will be sensitive or resistant to treatment with an ERBB3 inhibitor, e.g, an anti-ERBB3 antibody, is disclosed. The method is based on measurement of NRG1 expression at the RNA level, or at the protein level, in a tissue sample from the tumor.

The present invention relates to administering glial growth factor 2 (GGF2) to a patient in need thereof, to achieve serum levels of GGF2 within a desired therapeutic window determined based on the disease or disorder afflicting the patient. In a particular embodiment, the patient is suffering from a disease or disorder associated with reduced levels of myelination and the GGF2 is administered to promote myelination in the patient.

Provided herein are methods for promoting differentiation of cardiac progenitor cells toward myocytes and suppressing the conversion of cardiac progenitor cells into fibroblasts and myofibroblasts cells in a subject determined to have cardiac progenitor cells in or around the heart, by administering a therapeutically effective amount of an NRG-1 peptide or functional variant or fragment thereof. The methods disclosed herein can be used to treat, prevent, or delay the progression of cardiac injury, for example heart failure or myocardial infarction.

A cell culture comprising a mammalian cell line which is modified to express a heterodimer consisting of a progranulin polypeptide and a prosaposin polypeptide.

Assays to analyze quality and quantity attributes of fixed dose combinations are provided. In particular, assays for fixed dose combinations of two anti-HER2 antibodies, and for subcutaneous formulations comprising pertuzumab and trastuzumab are described herein.

Disclosed is a use of a proBDNF regulator in B cell-related diseases. Specifically, disclosed is a use of a reagent which suppresses or activates proBDNF activity or proBDNF signaling pathways in preparing a regulator which regulates B lymphocyte function. Also disclosed is a use of a regulator in preparing a drug which treats B lymphocyte dysfunction-related diseases, a use of an antibody in preparing a reagent or reagent kit which detects/treats B lymphocyte dysfunction-related diseases, and a method for predicting a treatment or prevention effect of treating or preventing B lymphocyte dysfunction-related diseases.

The present invention relates to administering glial growth factor 2 (GGF2) to a patient in need thereof, to achieve serum levels of GGF2 within a desired therapeutic window determined based on the disease or disorder afflicting the patient. In a particular embodiment, the patient is suffering from a disease or disorder associated with reduced levels of myelination and the GGF2 is administered to promote myelination in the patient.