IMMUNOLOGY AND PARTICULATES IN THERAPEUTICS: A MODERN GORDIAN KNOT





Ãâó : American Laboratory (www.americanlaboratory.com)

ÀúÀÚ : Dr. StevensonÀº American LaboratoryÀÇ ¸í¿¹ editor·Î 1960³â´ë ÈĹݺÎÅÍ Varian, Altex, Bio-Rad ¹× TosoHaas¿¡¼­ °èÃø ¹× ¾îÇø®ÄÉÀÌ¼Ç °³¹ß¿¡ Âü¿©ÇØ¿Ô½À´Ï´Ù. ±×´Â 1968³âºÎÅÍ American Laboratory¿¡ Á¤±âÀûÀ¸·Î ±â°íÇßÀ¸¸ç, »õ·Î¿î technology¿Í applications¿¡ °üÇÑ 450¿© ÆíÀÇ ³í¹®À» Àú¼úÇß½À´Ï´Ù. ( rlsteven@yahoo.com )

The Next Generation Protein Therapeutics

¡®Protein aggregatoin, stability, and solubility¡¯¸¦ ÁÖÁ¦·Î ÇÑ ¡®The Next Generation Protein Therapeutics Summit¡¯ (2014. 6. 4-6)Àº IBC Life Sciences (Westborough, MA)¿¡ ÀÇÇØ San Francisco¿¡¼­ ÁøÇàµÇ¾ú½À´Ï´Ù.

ÀÌ ¹ÌÆÿ¡¼­´Â »ý¹°ÇÐ Á¦Á¦ÀÇ ¹Ì°³Ã´ ¿µ¿ª¿¡ µµÀüÇÏ°í ÀÖ´Â Àü¹®°¡µé·ÎºÎÅÍ ¹Ì·¡¿¡ ´ëÇÑ ÀÇ°ßÀ» µéÀ» ¼ö ÀÖ¾úÀ¸¸ç, ³íÀÇµÈ ÁÖÁ¦´Â ´ÙÀ½°ú °°½À´Ï´Ù.

ÀÇ·áºÐ¾ßÀÇ ÁÖ¿ä ¿ä±¸¸¦ ÃæÁ·ÇÒ ¼ö ÀÖ´Â ´Ü¹éÁú scaffolds¿¡ °üÇÑ ÀÓ»ó ¿¬±¸ÀÇ ÃֽŠ¼º°ú
¼¼Æ÷¿¡ ´Ü¹éÁúÀ» Àü´ÞÇϱâ À§ÇÑ ¼º°øÀû Á¢±Ù ¹æ¹ý
È¿À², ¼Óµµ, Ç°Áú °³¼±À¸·Î ¿¬°áµÇ´Â °øÇÐ ¼³°èÀÇ µ¶Ã¢Àû Á¢±Ù ¹æ¹ý
Â÷¼¼´ë Ç×ü ¾à¹° °áÇÕü (ADC)ÀÇ °³¹ßÀ» °¡´ÉÇÏ°Ô ÇÏ´Â »õ·Î¿î conjugation, linker, payload ±â¼ú
¾Ï°ú ¹ÙÀÌ·¯½º¼º Áúȯ Ä¡·á¸¦ À§ÇÑ »õ·Î¿î ¸é¿ª Ä¡·á ¼³°è ¹× °³¹ß
Ç÷Àå ¹Ý°¨±â¸¦ ¿¬ÀåÇÒ ¼ö ÀÖ´Â ¼º°øÀûÀÎ PEG ´ëü ¹°Áú °³¹ß

Protein characterization

¸é¿ª°ú °ü·ÃµÈ ´Ü¹éÁúÀ» ¿¬±¸ÇÔ¿¡ À־ ´Ü¹éÁúÀÇ Æ¯¼º ºÐ¼®ÀÌ ¸Å¿ì Áß¿äÇÕ´Ï´Ù. Arvinte ±³¼ö´Â (University of Geneva, Switzerland) °­ÀÇ¿¡¼­ ´Ü¹éÁúÀÇ Æ¯Á¤ ¼ºÁú°ú drug delivery systemsÀ» ºÐ¼®ÇÏ´Â ¸ñÀû¿¡ ¸Â´Â ºÐ¼® ¹æ¹ýÀÇ Çʿ伺ÀÌ °­Á¶ÇÏ¿´½À´Ï´Ù. ƯÈ÷ ´Ü¹éÁúÀÇ aggregation Ư¼º°ú °ü·ÃµÇ¾î, aggregationÀ» ÀÏÀ¸Å°´Â ¿äÀÎ/º¯¼ö´Â ¸Å¿ì ¸¹À¸¸ç ÀÌ Æ¯¼ºÀ» ¹àÈ÷´Â Á¤ÀÇµÈ ±â¼úÀº ¾ø´Ù´Â Á¡ÀÌ ¾ð±ÞµÇ¾ú½À´Ï´Ù.

Several lectures on protein aggregation

»ç¶÷µéÀº ´ëºÎºÐ ¾î¶»°Ô Çϸé aggregationÀ» ÇÇÇÒ ¼ö ÀÖÀ»Áö¿¡ °ü½ÉÀ» º¸ÀÔ´Ï´Ù. ±×·¯³ª Arvinte ±³¼ö´Â ÀϺΠdrugs´Â ü³»¿¡¼­ aggregationÀÌ ÀϾÀ» ¶§ ´õ È¿°úÀûÀÏ ¼ö ÀÖ´Ù°í ÁöÀûÇϸç, ±× ¿¹·Î Human calcitonin°ú long-acting insulin anlogs¸¦ ¾ð±ÞÇÏ¿´½À´Ï´Ù. ÀÌ ¿Ü¿¡µµ ´Ü¹éÁú aggregation ¸ÞÄ¿´ÏÁò¿¡ ´ëÇÑ ¿©·¯ °­ÀÇ°¡ ÁøÇàµÇ¾ú´Âµ¥, ´Ü¹éÁúÀÇ biotherapeutics¸¦ Çâ»ó½ÃÅ°±â À§ÇØ °ü·ÃµÈ ¹®Á¦¸¦ ÇØ°áÇÏ°í È­ÇÐÀû ¹æ¹ýÀ» »ç¿ëÇÏ´Â ´ë¾È °³¹ß¿¡ ´ëÇÑ ³»¿ëÀ̾ú½À´Ï´Ù.

Measurement of particle size distribution

Dr. StevensonsÀº ´Ü¹éÁú aggregates À̽´¿¡ ´ëÇÑ »ç¶÷µéÀÇ ¸¹Àº °ü½ÉÀ» ¸ñ°ÝÇÏ¿´À¸¸ç ±âÁ¸¿¡ °³¹ßµÈ ±â±â°¡ ´Ü¹éÁú aggregatesÀÇ Æ¯¼ºÀ» ºÐ¼®Çϱâ À§ÇÑ ¸ñÀûÀ¸·Î »ç¿ëµÉ ¼ö ÀÖ´ÂÁö ±Ã±ÝÇß½À´Ï´Ù. ¸¶Ä§ Denise Nawrocki (Department of Viral Vaccine Research, Merck Research Laboratories, Merck & Co., West Point, PA)ÀÇ °­ÀÇ¿¡¼­ particle size distributionÀ» ÃøÁ¤Çϴµ¥ »ç¿ëµÇ´Â LUMiSizer¢ç (LUM GmbH, Berlin, Germany) ±â±â°¡ ¼Ò°³µÇ¾ú½À´Ï´Ù. µ¶ÀÏ LUM»çÀÇ LUMiSizer´Â 80% solids°¡ ¿ëÇØ/ÇöŹµÇ¾îÀÖ´Â °í³óµµÀÇ ¿ë¾×¿¡µµ Àû¿ë°¡´ÉÇÏ´Ù°í ÇÏ¿´½À´Ï´Ù. Arvinte ±³¼öÀÇ °æÇè¿¡ µû¸£¸é paints, polymers¸¦ ºñ·ÔÇÑ ´Ù¸¥ suspension¿¡µµ Àû¿ë °¡´ÉÇÔÀ» º¸ÀåÇÑ´Ù°í ÇÏ¿´½À´Ï´Ù.

LUMiSizer´Â ¿ø½ÉºÐ¸® ¿ø¸®¸¦ »ç¿ëÇϸç Àü¿ë sample tubeÀÎ cellÀ» ¼öÆòÀ¸·Î LUMiSizer ³»ºÎÀÇ rotor¿¡ ÀåÂøÇÕ´Ï´Ù. Rotor°¡ µ¹¸é¼­ ¿ø½É·ÂÀ¸·Î »ùÇà ³» ÀÔÀÚ¸¦ ÃþºÐ¸®½ÃÅ°°Ô µË´Ï´Ù. ½Ã·á°¡ ´ã±ä cellÀÌ È¸ÀüÇÒ ¶§, laser´Â cellÀÇ major axis¸¦ µû¶ó optical profile (ºû Åõ°úµµ)À» ÃøÁ¤ÇÕ´Ï´Ù. »ùÇà ³» ÀÔÀÚÀÇ ±¸Á¶¿¡ µû¶ó ´Ù¸¥ optical profileÀÌ ±â·ÏµË´Ï´Ù.





Nawrocki´Â LUMiSizer¿Í light scattering (LS)ÀÇ °á°ú¸¦ ºñ±³ÇÏ¿´½À´Ï´Ù. LUMiSizer¿¡¼­ ÃøÁ¤µÇ´Â »ùÇÃÀÇ ÃÖ¼Ò ³óµµ´Â 0.00015 vol %ÀÌ°í, ºÎÇÇ´Â 0.05 ~ 2.0 mL ÀÔ´Ï´Ù. ÃøÁ¤ ½Ã°£Àº 1ÃÊ ~ 99 ½Ã°£À̸ç, rotor´Â 1ȸ¿¡ 12°³ »ùÇÃÀ» ó¸® ÇÒ ¼ö ÀÖ½À´Ï´Ù. »ùÇÃÀ» cell¿¡ loadingÇÏ°í rotor¿¡¼­ ȸÀü½ÃÅ°¸é¼­ ÃøÁ¤ µÇµµ·ÏÇϸç, »ùÇÃÀº ȸ¼ö °¡´ÉÇÏ°í Àç È¥ÇÕ µÉ ¼ö ÀÖ½À´Ï´Ù. ÀÌ »ç·Ê ¿¬±¸¿¡¼­, LS´Â Å« ÀÔÀڵ鿡 Àß ¹ÝÀÀÇÏ¿©, ÀϹÝÀûÀ¸·Î LUMiSizerº¸´Ù 10¹è ´õ Å« particle/polymer¿¡ ´ëÇÑ °ªÀ» Á¦°øÇÏ´Â °ÍÀ¸·Î ³ªÅ¸³µ½À´Ï´Ù. LUMiSizer´Â ÀÛÀº ÀÔÀÚ (40nm~)±îÁö ÃøÁ¤ÇÒ ¼ö ÀÖÀ¸¸ç, LS¿Í ÃøÁ¤ÇÏ´Â ÀÔÀÚ Å©±âÀÇ Â÷ÀÌ¿¡µµ ºÒ±¸ÇÏ°í LUMiSizer´Â µ¿ÀÏÇÑ Á¤¼º °á°ú¸¦ Á¦°øÇÏ¿´½À´Ï´Ù.

Nawrocki´Â ¶ÇÇÑ LUMiSizer°¡ Ưº°È÷ ¹é½ÅÀÇ ¾ÈÁ¤¼º Çâ»óÀ» À§ÇÑ Ã·°¡¹°À» Æ÷ÇÔÇÏ´Â formulation ¿¬±¸¿¡ »ç¿ëµÉ ¼ö ÀÖ´Ù°í ÇÏ¿´½À´Ï´Ù. LUMiSizer´Â ºü¸¥ ¼Óµµ·Î ºÐ»ê ¾ÈÁ¤¼ºÀ» ÃøÁ¤ÇÏ¿© LS¿Í ºñ±³ÇÏ¿© ¿¬±¸ ½Ã°£À» 25%³ª ÁÙ¿©ÁÖ¾ú½À´Ï´Ù. À̸¦ ÅëÇØ °¡Àå ¾ÈÁ¤¼ºÀ» º¸À̴ ÷°¡¹°ÀÇ ºñÀ²À» µµÃâÇÒ ¼ö ÀÖ¾úÀ¸¸ç, freeze-thaw stability studyº¸´Ù ÃøÁ¤ ½Ã°£À» 30%³ª ÁÙÀÏ ¼ö ÀÖ´Ù°í ¼Ò°³ÇÏ¿´½À´Ï´Ù.

Benefits of LUMiSizer¢ç

´Ù¾çÇÑ instability mechanism ±¸º° °¡´É
³óÃàµÈ (~90%) »ùÇà ºÐ¼® °¡´É
»ùÇÃÀÇ °íÀ¯ÇÑ figerprints¸¦ ÃøÁ¤
ÀÔÀÚ density ÃøÁ¤ °¡´É
°í³óµµÀÇ »ùÇÿ¡¼­µµ ÀÔÀÚ Å©±â ÃøÁ¤ÀÌ °¡´É
»ùÇÃÀÇ º¯È­¸¦ topºÎÅÍ bottom±îÁö ¿Ïº®ÇÏ°Ô °üÂûÇÒ ¼ö ÀÖÀ½
ºü¸£°í Á÷Á¢ÀûÀ¸·Î ºÐ»ê ¾ÈÁ¤¼ºÀ» ÃøÁ¤
Shelf-lifeÀÇ ºñ±³ ¿¹Ãø °¡´É
±¤¹üÀ§ÇÑ ¿Âµµ ¹üÀ§¿¡¼­ ÃøÁ¤ °¡´É (4 ~ 60 ¢ªC)
12°³ »ùÇÃÀÇ ºÐ»ê ¾ÈÁ¤¼ºÀ» µ¿½Ã¿¡ ÃøÁ¤ °¡´É
ºÐ»êÀÇ ÃÖÀûÈ­¿¡ È°¿ë
ºü¸£°í ½¬¿î Á¶ÀÛ, ºÐ¼®

LumiSizer Dispersion Analyzer




LumiFuge Stability Analyzer




LumiReader PSA Separation Analyzer




 
(ÁÖ)¿µÁøÄÚÆÛ·¹ÀÌ¼Ç   |   ´ëÇ¥ : ÀÌÇü¿­   |   »ç¾÷ÀÚµî·Ï¹øÈ£ : 138-81-34745
±º Æ÷ º» »ç   |   (15853) °æ±âµµ ±ºÆ÷½Ã ÇѼ¼·Î 48 ³²¿øºôµù 2Ãþ   |   ÀüÈ­ : 1577-7956 (1)   |   Æѽº : 031-457-9188   |   À̸ÞÀÏ : info@yjcorp.co.kr
´ë Àü Áö »ç   |   (34036) ´ëÀü½Ã À¯¼º±¸ Å×Å©³ë10·Î 29 ÆÄÅ©ÆÓ¸®½º 2Ãþ   |   ÀüÈ­ : 1577-7956 (2)   |   Æѽº : 042-932-1266   |   À̸ÞÀÏ : info@yjcorp.co.kr