Hiroaki Nagashima

Biography

Process Development Research Scientist Company Name Chugai Pharmaceutical Co., Ltd. Dates Employed Apr 2016 – Present Employment Duration 1 yr 6 mos Location Within 23 wards, Tokyo, Japan [API Process Development Department (Bio Technology) (2016-)] 1. Cell culture process development 2. Quality by Design approach Manager Company Name Roche Dates Employed Oct 2014 – Mar 2016 Employment Duration 1 yr 6 mos Location Penzberg, Germany [Development Recovery & DSP, Pharma Technical Development Europe (2014-)] 1. Process development for API in late stage. 2. Collaboration with Chugai for a systematic and comprehensive process development (Quality by Design approach). 3. Collaboration with Genentech for a Quality by Design approach. Scientist Company Name Chugai Pharmaceutical Co., Ltd. Dates Employed Apr 2006 – Sep 2014 Employment Duration 8 yrs 6 mos Location API Process Development Department [API Process Development Department (Bio Technology) (2009-2014)] 1. Cell culture process (a) Platform chemically defined media development with a foreign company (Leader on Chugai side, 6 members on Chugai side). (b) Cell line characterization by a metabolic approach with a foreign company (Leader on Chugai side, 4 members on Chugai side). (c) Cell culture process development for monoclonal antibody production (Statistical adviser). 2. Quality by Design approach (a) Establishment and implementation for monoclonal antibody production (Leader, 6 members & 3 directors) (b) Establishment and implementation for antibody quality (Leader, 8 members & 7 managers). (c) Collaboration with Roche (Leader on Chugai side, 5 members & 4 directors on Chugai side). (d) Reviews of new drug applications from Roche and Genentech. [Biotechnology and Research Department (2006-2009)] 1. Cell culture process development for monoclonal antibody production. 2. Process characterization and process validation of cell culture process for commercial production. 3. Establishment of a statistical material use program which controls lot-to-lot variability for commercial production (Leader, 5 members). -Scientific literature (First author) 1. Application of a Quality by Design Approach to the Cell Culture Process of Monoclonal Antibody Production, Resulting in the Establishment of a Design Space, J Pharm Sci, 2013;102(12):4274-83.

Research Interest

Pharmaceutical Science