Abstract
On the development of subcutaneous injection form of antibody drugs, small injection volume (i.e. 1mL) is the key achievement for enabling subcutaneous injection. Therefore, stable formulation and manufacturing process of highly concentrated/viscous antibody solution should be established for reducing injection volume. For the treatment of chronic diseases, pre-filled syringe or autoinjector is expected to improve the quality of life of patients. Considering these requirements and circumstances, we have established the drug product of ACTEMRA® 162mg Syringe and Auto-Injector for SC Injection. This paper describes the approach for establishing ACTEMRA® SC injection.
The contents in this paper is mainly disclosed in Pre-filled Syringe Seminar 2016 Tokyo (May 17-18, 2016) by PDA Japan Chapter and includes the additional information of formulation and manufacturing process investigation.
