의약품 안정성시험 및 바이오의약품 분석지원센터 구축 연구

Abstract

This study was undertaken to suggest the necessity of establishing stability test and biopharmaceutical analysis support center. Feasibility study on center establishment was performed as online survey to factory manager and person in charge in 39 pharmaceutical companies in Korea. More than seventy percent of 39 companies responded that they need to establish it. Eighty percent of respondents answered that they would entrust the entire test items of stability test and 71.8% of respondents answered that they would entrust biopharmaceutical cell bank and protein analysis. The construction cost of two centers with 2 stories and 1 basement floor and 3000m2 was 6.37 billion won. The stability test center need to 173 EA of 71 types of equipment and 4.086 billion won in budget for equipment purchases. The biopharmaceutical analysis support center need to 169 EA of 77 types of equipment and about 7.2 billion won in budget for equipment purchase. Total cost for construction and equipment purchase was 17.65 billion won. The establishment of two centers with expertise and efficiency would provide the competitiveness of the pharmaceutical industry in Korea.