PROFILE

권오석 보건연구관

Regulatory Process and Requirements for Biological Products

This lecture will inform the regulatory process for biological products in Korea and provide the data requirements in terms of quality, safety, and efficacy

식품의약품안전처 유전자재조합의약품과

EDUCATION

Korea University Ph.D. 2019 Biotechnology
Gwangju Institute of Science and Technology M.S. 2001 Life Science
Korea University B.S. 1999 Biology

Positions Held

2006-Present Quality assessor for biological products including recombinant protein products, biosimilars, and vaccines, MFDS
2004-2006 Researcher, R&D for Biotech Pharmaceuticals, LG Life Science Inc.
2001-2003 Researcher, R&D for Bio-Diagnosis Kit, Metabolab Inc.

Publications

1.“Validation of monosaccharide composition assay using HPLC-UV platform for monoclonal antibody products in compliance with ICH guideline,” Bulletin of the Korean Chemical Society, 39(12) (2018), 1394-1399 (with I.U. Oh, M.J. Oh, S.H. Hong, C.W. Kim and H.J. An).
2.“Research on the advancement of standards and specifications of biologics in Korea,” Biologicals, 53 (2018), 76-77 (with J. Son, C. Kim and H. Cho).
3.“Considerations of critical quality attributes in the analytical comparability assessment of biosimilar products,” Biologicals, 48 (2017), 101-108 (with J. Joung, Y. Park, C.W. Kim and S.H. Hong).
4.MFDS Research Project, 09121MFDS371, “Studies on the establishment of methods and guidance for analysis of N-glycan in recombinant protein products”, 2009.
5.MFDS Research Project, 08121MFDS291, “Studies on guidance of biotechnological products and quality aspects of recombinant protein products”, 2008.