| [±¹¿ÜÀ¯°ü±â°ü] AAV Gene therapy products °ü·Ã USP Expert panel ¸ðÁý ¾È³» (~1/28) | |
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| ÀÛ¼ºÀÚ : °ü¸®ÀÚ (info@carm.or.kr) | µî·ÏÀÏ : 2022-01-12 Á¶È¸¼ö : 202 |
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¹Ì±¹ ¾àÀüÀ§¿øÈ¸(USP)¿¡¼ AAV Gene therapy products °ü·Ã Expert panelÀ» ¸ðÁýÇÑ´Ù°í ÇÏ¿© ¾Æ·¡¿Í °°ÀÌ ¾È³» µå¸®¿À´Ï, ȸ¿ø»ç ¿©·¯ºÐÀÇ ¸¹Àº °ü½É°ú ½Åû ºÎʵ右´Ï´Ù. - ¾Æ ·¡ - [USP AAV Gene therapy products EP ¸ðÁý °³¿ä] ¢Á ¸ðÁýºÐ¾ß : the Adeno-associated virus (AAV) Gene Therapy Expert Panel (EP) ¢Á ¸ðÁý±â°ü : USP (¹Ì±¹ ¾àÀüÀ§¿øÈ¸) ¢Á Role(s) : - AAV vector design, manufacturing, quality control, regulatory considerations¿¡ ´ëÇÑ USP General Chapter¸¦ ÁýÇÊÇÔ - the Biologics and Biothechnology 5 Monographs (Dr. Mehrshid Alai°¡ ÀÇÀåÀ¸·Î ÀÖ´Â Advanced Therapies Expert Committee) ÀÇ Áö½Ã¿¡ µû¶ó ±Ç°í¾ÈÀ» Á¦½ÃÇϰí ÀÛ¾÷À» ¼öÇàÇÔ - Àü¹®¼ºÀ» ¹ÙÅÁÀ¸·Î general chapterÀÇ sections ÀÛ¼º ¹× ´Ù¸¥ sectionsÀÇ ÆíÁý¿¡µµ Àû±ØÀûÀ¸·Î ±â¿©ÇÔ - physical reference standards¸¦ °³¹ßÇÏ´Â µ¿¾È ÇöÀçÀÇ °üÇàÀ» °øÀ¯Çϰí, ½ÇÇè½Ç °£ ¿¬±¸ µ¥ÀÌÅ͸¦ °ËÅäÇÔ ¢Á Ȱµ¿°èȹ : monthly teleconferences¸¦ ÅëÇÑ ¹ÌÆÃ ÁøÇà (EP Ȱµ¿ ±â°£ µ¿¾È Rockville¿¡¼ face-to-face ¹ÌÆÃ ÁøÇà ¿¹Á¤) ¢Á Expertise Required : - Nucleic acid technology analytics for viral genome titer, mutation analysis, and residual quantitation - Analytics for biophysical assessment of AAV particles, including empty/full ratio and aggregation - Vector and capsid design for mitigation or pre-existing immunity and for establishing cell and tissue targeting - Manufacturing and purification of AAV using insect cell lines and baculovirus - Manufacturing and purification of AAV using helper virus - AAV genotoxicity and genome integration ¢Á ¸ðÁý±â°£ : ~ 2022. 1. 28.(±Ý) ¢Á ½Åû¹æ¹ý : ¾Æ·¡ ȨÆäÀÌÁö¿¡¼ °¡ÀÔ ÈÄ ½Åû °¨»çÇÕ´Ï´Ù. |
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| ÀÌÀü±Û | ¹ÙÀÌ¿ÀÄÚ¸®¾Æ 2022 (BIO KOREA 2022) Àü½ÃºÎ½º Âü¿© ±â¾÷ ¸ðÁý ¾È³» (~ 2/25) |
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| ´ÙÀ½±Û | [ݵͱ] ¹ÝÁÖ¿¬ ¿î¿µÆÀÀå ¸ðÄ£»ó ¾È³» |
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