±³À°¸í | [Merck] Best practices of pDADMAC Flocculation for a successful GMP biomanufacturing | ºÐ·ù | ¼¼¹Ì³ª |
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½ÅûÀÏÁ¤ | 2023.02.13~2023.03.24 | Çà»çÀÏÁ¤ | 2023.03.28~2023.03.28 |
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✅ ÁÖÁ¦: Best practices of pDADMAC Flocculation for a successful GMP biomanufacturing
✅ ÀÏÁ¤: 2023³â 3¿ù 28ÀÏ(È) ¿ÀÈÄ 3½Ã-4½Ã (KST)
pDADMACÀº ³ôÀº ¼¼Æ÷ ¹Ðµµ ¹è¾ç¿¡ µû¸¥ Ãß°¡ Á¤Á¦ °øÁ¤À» ¿¹¹æÇÒ ¼ö ÀÖ´Â »õ·Î¿î ¼Ö·ç¼ÇÀÌ µÉ ¼ö ÀÖ½À´Ï´Ù.
º» ¿þºñ³ª¸¦ ÅëÇØ ¼º°øÀûÀÎ GMP Á¦Á¶ °øÁ¤À» µÞ¹ÞħÇÏ´Â QbD, DoE, ICH-Q3A¿¡ ±â¹ÝÇÑ À§Çè Æò°¡ ¹× pDADMACÀÇ clearance test¿¡ ´ëÇØ ¾Ë¾Æº¸¼¼¿ä!
¿þºñ³ª¿¡¼´Â ´ÙÀ½°ú °°Àº ³»¿ëµéÀ» ´Ù·ç°íÀÚ ÇÕ´Ï´Ù:
l Design of Experiments for pDADMAC use in GMP biomanufacturing
l Risk assessment strategies for pDADMAC use in GMP biomanufacturing
l Clearance testing of residual pDADMAC for GMP manufacturing
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