È¿¼ÒÀÇ Ç°Áúµî±Þ RUO/HQ/GMP
- ¹é½Å ¿¬±¸ ¡¤ Ä¡·áÁ¦µîÀÇ ÀǾàÇ° °³¹ß µî¿¡¼ ½ºÄÉÀÏ ¾÷ ¹× ÇÁ·Î¼¼½º °³¹ß ½Ã ´Ü°èº°·Î »ç¿ë
´ç»ç´Â ÀÏ¹Ý ¿¬±¸¿ë ½Ã¾à (RUO grade) ¿Ü¿¡µµ Ä¡·áÁ¦ ¹× ¹é½ÅÀÇ Á¦Á¶ °øÁ¤ ÇÁ·Î¼¼½º °³¹ßÀ» ¸ñÀûÀ¸·Î ÇÑ High Quality (HQ) grade¿Í Ä¡·áÁ¦³ª ¹é½ÅÀÇ ¿øÀç·á·Î »ç¿ëÇÒ ¸ñÀûÀÇ GMP grade µî °¢ °³¹ß ´Ü°è¿¡ ¸Â°Ô »ç¿ë °¡´ÉÇÑ È¿¼Ò¸¦ ÆǸÅÇÏ°í ÀÖ´Ù. ÀÌ·¯ÇÑ È¿¼ÒµéÀº Á¦Á¶ ½ºÄÉÀÏ¿¡ ¸Â°Ô ´ë¿ë·® Ä¿½ºÅÒ Á¦Ç°À¸·Î ÁÖ¹®, ±¸¸ÅÇÒ ¼ö ÀÖÀ¸¸ç, ¿¬±¸ ¹× ¸ñÀû¿¡ ¸Â°Ô ¾Æ·¡¿Í °°ÀÌ ¼±ÅÃÇÏ¿© »ç¿ëÇÒ ¼ö ÀÖ´Ù.
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Research |
Development |
Manufacturing |
Quality feature |
Evaluation stage |
RUO grade |
HQ grade |
GMP grade |
Exonulclease/Endonuclease free |
Final formulation |
¥´ |
¥´ |
¥´ |
Purity testing
- Endotoxin, bioburden
- Host cell-derived DNA/RNA contamination |
Final formulation |
- |
¥´ |
¥´ |
AOF: Animal- and human-origin free |
Final formulation |
- |
¥´ |
¥´ |
Raw materials |
- |
- |
¥´ |
¥â-lactam free |
Final formulation |
- |
¥´ |
¥´ |
Raw materials |
- |
- |
¥´ |
Ç¥ 1. ´ç»çÀÇ RUO, HQ, GMP grade ¾È³». HQ grade´Â ´Ù¼öÀÇ Ç׸ñ¿¡¼ GMP grade¿Í °°Àº Ç°Áú·Î °ü¸®Çϸç, RUOº¸´Ù ´õ¿í ´Ù¾çÇÑ Ç׸ñÀ» °ü¸®ÇÑ´Ù.
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Research |
Development |
Manufacturing |
Evaluation stage |
RUO grade |
HQ grade |
GMP grade |
Raw materials |
ISO 9001:2015 |
ISO 9001:2015 |
PIC/S GMP |
Manufacturing process |
ISO 9001:2015 |
ISO 9001:2015 |
PIC/S GMP |
Ç¥ 2. °¢ RUO, HQ, GMP gradeÀÇ ±Ù°Å±ÔÁ¤.
- RUO grade :
ÀÏ¹Ý ¿¬±¸¿ë ½Ã¾à°ú µ¿µîÇÑ Ç°Áú°ü¸®
- HQ grade :
GMP grade¿Í µ¿ÀÏÇÑ Ç°Áú°ü¸®¸¦ ÇÏ°í, µ¿µîÇÑ ¿øÀç·á¿Í °øÁ¤À» »ç¿ëÇÏ¿© Á¦Á¶.*
¹é½Å Á¦Á¶ °øÁ¤ÀÇ °³¹ß µîÀÇ ¸ñÀûÀ¸·Î »ç¿ë °¡´É.
* GMP ½Ã¼³¿¡¼ Á¦Á¶µÇÁö´Â ¾ÊÀ½.
- GMP grade :
PIC/S (Pharmaceutical Inspection Agreement and Pharmaceutical Inspection Joint Scheme)ÀÇ GMP °¡À̵å¶óÀο¡ µû¶ó Á¦Á¶ ¹× Ç°Áú½ÃÇèÀ» ÁøÇà. ÀǾàÇ°ÀÇ ¿ø·á Á¦ÀÛ¿¡ »ç¿ë °¡´É
HQ grade ¹× RUO grade Á¦Ç° ¸®½ºÆ®
High Quality (HQ) grade È¿¼Ò´Â °øÁ¤ °³¹ß »Ó ¾Æ´Ï¶ó ¿£µµÅå½Å °ü¸®°¡ ÇÊ¿äÇÑ GLP/µ¿¹°½ÇÇè ¹× ¿¬±¸ °³¹ß (¶Ç´Â RUO bulk)¿¡µµ ÀÌ¿ëÇÒ ¼ö ÀÖ½À´Ï´Ù. HQ grade Á¦Ç° °ü·Ã ¹®ÀÇ»çÇ×Àº ´ÙÄ«¶óÄÚ¸®¾Æ °í°´Áö¿ø (TEL. 02-2081-2510, Email.
support@takara.co.kr)À¸·Î ¿¬¶ô ÁÖ¼¼¿ä.