We choose packaging materials conform with requirements of Ch-P, EP, and USP. Formulation process of drug substance will sustain adequate stability at 10-50mg/ml under various manufacturing stresses. Formulation study is designed to address potential stability issues at high concentration by selecting appropriate excipient and monitoring critical product quality attributes in designed formulation matrix under accelerated storage conditions. A number of other product quality attributes will be evaluated: viscosity, particles, visual appearance, charge isoforms, aggregation and degradations. Formulation process of drug product  will sustain adequate stability at 10-100mg/ml in FDA/EMA/NMPA registered containers under various manufacturing stresses.