ÃÖ±Ù¿¡ °¡Àå ¸¹ÀÌ °ø±ÞµÈ Top 7°³ ¾àǰ Áß 6°³ÀÇ ¾àǰÀÇ ±¸Á¶(drug formulation)°¡ ´ÜÀÏ °Å¿ï»óÀ̼ºÁúü Á¦Ç°µéÀÏ Á¤µµ·Î, ´ÜÀÏ °Å¿ï»óÀ̼ºÁúü ÀǾàǰ¿ø·á(Single-Enantiomer active pharmaceutical ingredients)´Â ºí·°¹ö½ºÅÍ±Þ ¾àǰµéÀÇ Æ¯Â¡ÀÌ µÇ¾ú´Ù.
ÇöÀç, FDA´Â ÃÖÁ¾ ÀǾàǰ¿ø·áÀÇ Chiral ¼øµµ(purity)¿¡ ´ëÇØ ¾öÁßÇÑ ±ÔÁ¤À» µµÀÔÇß°í ÀÌ·Î ÀÎÇØ, »õ·Î¿î Chiral ¾àǰµéÀÇ °³¹ß¿¡ Å« ¿µÇâÀ» ³¢Ä¡°Ô µÇ¾ú´Ù.
¼ø¼öÇÑ °Å¿ïÀ̼ºÁúüÀÇ »ý¹°ÇÐÀû Ȱµ¿Àº ¾à¹°°³¹ßÀÇ lead optimization ´Ü°èÀÎ ÀüÀÓ»ó½ÇÇè(pre-clinical) ±â°£ Áß¿¡ °¡Ä¡°¡ Æò°¡ µÇ¾îÁö°í, À̶§¿¡ °¢ °Å¿ï»óÀ̼ºÁúüÀÇ ¼Ò·®(miligrams to gram)À» ¾ò°Ô µÈ´Ù.
ÀüÀÓ»ó½ÇÇè ´Ü°è¿¡¼­ ¿ä±¸µÇ´Â Á¤µµÀÇ chiral ¾àǰÀÇ ¾çÀ» ´ë±Ô¸ð·Î Chiral API »ý»ê¿¡ Àû¿ëµÉ ¼ö ÀÖ´Â Method¸¦ ¼Ò°³Çϰï Çß´Ù.
ÀÌ·¯ÇÑ MethodÁß ÇϳªÀÎ The Simulated Moving Bed Chromatography(SMBC) °úÁ¤Àº Á¦¾àºÐ¾ß¿¡¼­ °¡Àå ¸¹Àº ÆÇ¸Å·®À» °¡Áö´Â Pfizer, Zoloft¿¡ ÀÇÇØ Á¦Á¶µÈ ¾àǰµéÀÇ ¿©·¯ ¼ø¼öÇÑ °Å¿ï»óÀ̼ºÁúü ÀǾàǰ¿ø·áÀÇ ´ë±Ô¸ð»ý»ê(Large-scale production)¿¡ ¼º°øÀûÀ¸·Î Ȱ¿ëµÇ¾ú´Ù.
SMBC TechniqueÀÇ °¡Àå Å« Ư¡ Áß Çϳª´Â ÀÛÀº scaleÀÇ Semba OctaveTM Chromatography SystemÀ¸·Î ±âÁ¸ÀÇ ´ë±Ô¸ð chromatography¿Í ¶È°°Àº À̵æÀ» ½ÇÇö½Ãų ¼ö ÀÖÀ» »Ó ¾Æ´Ï¶ó ºÐÃë·®µµ ±âÁ¸ÀÇ Á¦Ç°¿¡ ºñÇØ ¸¹´Ù´Â Á¡ÀÌ´Ù.
¾Æ·¡ÀÇ ¿¹Á¦´Â Semba OctaveTM system°ú Astec CHIROBIOTICTM V2 chiral columnÀ» ÀÌ¿ëÇÏ¿©(+)/(-) 5-methyl 5-phenylhydantoin racemic mixtureÀÇ µÎ °³ÀÇ ¼ø¼öÇÑ °Å¿ï»óÀ̼ºÁúüÀÇ ºÐ¸®µÈ ¿¹¸¦ º¸¿©ÁØ´Ù.

Column : 8 x Astec CHIROBIOTICTM V2, 5 cm x 10 mm, 15 ¥ì
Sample : 5-methyl 5-phenylhydantoin racemate (selectivity = 1.39)
Purification : 3-2-3 SMBC
Feed concentration : 10 mg/ml
Desorbent : 100% MeOH
Recovery : 90%
Productivity : >35 mg/h each enantiomer