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[±¹¿ÜÀ¯°ü±â°ü] AAV Gene therapy products °ü·Ã USP Expert panel ¸ðÁý ¾È³» (~1/28)
ÀÛ¼ºÀÚ : °ü¸®ÀÚ (info@carm.or.kr) µî·ÏÀÏ : 2022-01-12  Á¶È¸¼ö : 55  
¹Ì±¹ ¾àÀüÀ§¿øȸ(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 ºÎŹµå¸³´Ï´Ù.

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[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§¿øȸ)
¢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¦½ÃÇÏ°í 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¯ÇÏ°í, ½ÇÇè½Ç °£ ¿¬±¸ µ¥ÀÌÅ͸¦ °ËÅäÇÔ
¢Á È°µ¿°èȹ
: monthly teleconferences¸¦ ÅëÇÑ ¹ÌÆà ÁøÇà
(EP È°µ¿ ±â°£ µ¿¾È Rockville¿¡¼­ face-to-face ¹ÌÆà 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


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