의약품 안정성시험 및 바이오의약품 분석지원센터 구축 연구

Abstract

This study was undertaken to suggest the necessity of establishing stability test and biopharmaceutical analysissupport center. Feasibility study on center establishment was performed as online survey to factory manager and personin charge in 39 pharmaceutical companies in Korea. More than seventy percent of 39 companies responded that they needto establish it. Eighty percent of respondents answered that they would entrust the entire test items of stability test and71.8% of respondents answered that they would entrust biopharmaceutical cell bank and protein analysis. The constructioncost of two centers with 2 stories and 1 basement floor and 3000m2 was 6.37 billion won. The stability test center needto 173 EA of 71 types of equipment and 4.086 billion won in budget for equipment purchases. The biopharmaceuticalanalysis support center need to 169 EA of 77 types of equipment and about 7.2 billion won in budget for equipmentpurchase. Total cost for construction and equipment purchase was 17.65 billion won. The establishment of two centers withexpertise and efficiency would provide the competitiveness of the pharmaceutical industry in Korea.