Patent ID: 8758747
Filing Date: 2014-06-24
Classification: A61K,A61P,C07K

Abstract:
1. A process for the production of a lyophilized pharmaceutical preparation of monoclonal or polyclonal antibodies, comprising a) producing an aqueous preparation comprising a monoclonal or polyclonal antibody as the active substance at a concentration up to 20 mg/ml, sucrose in a concentration of 35 mg/ml to 75 mg/ml, an amino acid selected from the group consisting of arginine or ornithine in a concentration of 10 mg/ml to 25 mg/ml and a surfactant selected from the group consisting of Tween 20 (Polyethylene glycol sorbitan monolaurate) and Pluronic F68 (polyoxyethylene-polyoxypropylene polymer) in a concentration of 0.1 mg/ml, and b) lyophilizing said aqueous preparation.