[27PO6-am1] Regulatory sciences (pharmaceuticals, etc.)-1

[27PO6-am1-06] Collaborative study of size exclusion chromatography for evaluation of small aggregates in therapeutic monoclonal antibodies

○Hiroko Shibata¹, Akira HARAZONO¹, Masato KIYOSHI¹, Rie TAKESHITA², Teruhisa MANNEN², Tomohiro TAKASUGI³, Yu HAYASHI³, Michiko AKIMARU⁴, Shuntaro SAITO⁴, Tomoko MURAKAMI⁵, Mayumi NAKAKO⁵, Atsushi NAKANO⁶, Takuya SHINDO⁷, Kazuki IWASHITA⁸, Kazumasa YOKOYAMA⁹, Naomi OHBAYASHI¹⁰, Masatoshi YAMADA¹¹, Yukio HARA¹², Junji YAMASHITA¹², Kazuhiro MIYANABE¹³, Takeshi NISHIHAMA¹⁴, Akira MARUYAMA¹⁴, Yuya MIYAHARA¹⁵, Kenji SASAKI¹⁵, Shizuka KUROSAWA¹⁶, Elena KRAYUKHINA¹⁷, Masanori NODA¹⁷, Susumu UCHIYAMA¹⁸, Akiko ISHII-WATABE¹ (1. NIHS, 2. AJINOMOTO CO., INC., 3. Astellas Pharma Inc., 4. Daiichi Sankyo Co., Ltd., 5. Sumitomo Dainippon Pharma Co., Ltd., 6. Japan Blood Products Organization , 7. JCR Pharmaceuticals Co., Ltd., 8. Kyowa Kirin Co., Ltd., 9. Kissei Pharmaceutical Co.,Ltd, 10. Meiji Seika Pharma Co., Ltd., 11. Nippon Kayaku Co., Ltd., 12. NIHON PHARMACEUTICAL CO.,LTD., 13. Ono Pharmaceutical co., ltd., 14. Takeda Pharmaceutical Co., Ltd, 15. Mitsubishi Tanabe Pharma Co,, 16. Toray Research Center, Inc., 17. U-Medico Inc., 18. Grad. Sch. Eng, Osaka Univ.)