Antibody Formulations And Methods

摘要

The invention provides antibody formulations and methods useful for prophylaxis or treatment of synucleinopathies, including Parkinson's disease.

主权项

1. A pharmaceutical formulation comprising:
(a) a chimeric, veneered, or humanized version of antibody 9E4 (ATCC Accession Number PTA-8221), or a fragment thereof that specifically competes for binding to antigen with 9E4, wherein the antibody is present at a concentration within the range from about 10 mg/mL to about 50 mg/mL; (b) citrate buffer or succinate buffer present at a concentration within the range from about 10 mM to about 30 mM; (c) one or more sugars and polyols (“sugar/polyol”) selected from:
(i) trehalose present at a concentration within the range from about 220 mM to about 260 mM,(ii) sucrose present at a concentration within the range from about 220 mM to about 260 mM,(iii) and a mixture of sucrose present at a concentration within the range from about 20 mM to about 40 mM and mannitol present at a concentration within the range from about 200 mM to about 220 mM; and (d) polysorbate 20 present at a concentration within the range from about 0.005% to about 0.05% by weight; wherein the formulation is characterized by a pH within the range from about 5.5 to about 7.