½ÃÇèºÐ¾ß
¹ÙÀÌ¿ÀÀǾàÇ° ¹× ÀÇ·á±â±âÀÇ ¾ÈÀü¼ºÀ» °ËÁõÇÒ ¼ö ÀÖµµ·Ï ü°èÀûÀ¸·Î Áö¿øÇص帳´Ï´Ù
½ÃÇèºÐ¾ß
¤ýCell Line Validation
¤ýMicrobiological Test
¤ýViral Clearance Studies
¤ýOther Services

 

¤ýMicrobiological Test

Microbiological Test

½ÃÇè¼Ò°³

º¹Á¦°¡´É ¹ÙÀÌ·¯½º º¤ÅÍ °ËÃâ½ÃÇè, ¹«±Õ½ÃÇè, ¸¶ÀÌÄÚÇö󽺸¶ ºÎÁ¤½ÃÇè, ¹ÙÀÌ·¯½º ºÎÁ¤½ÃÇè µîÀ» ÅëÇØ ´Ù¾çÇÑ ½ÃÇè¹°ÁúÀÇ ¹Ì»ý¹°ÇÐÀû ¾ÈÁ¤¼ºÀ» °ËÁõÇÑ´Ù.

Àû¿ë¹üÀ§

´ÙÀ½°ú °°Àº ´Ù¾çÇÑ °Ë»ç¹°Áú¿¡ ´ëÇÏ¿© ¹Ì»ý¹°ÇÐÀû ¾ÈÀü¼ºÀ» °ËÁõÇÑ´Ù.

¤ý¸¶½ºÅÍ ¼¼Æ÷ÀºÇà (MCB, master cell bank)
¤ýÁ¦Á¶¿ë ¼¼Æ÷ÀºÇà (WCB, working cell bank)
¤ý»ý»êÁ¾°á¼¼Æ÷ (EOPC, end of production cells)
¤ý¿¬±¸¿ë ¼¼Æ÷ÀºÇà (Research cell bank)
¤ý°øÁ¤À» °ÅÄ¡Áö ¾ÊÀº ¿ø·á (Unprocessed Bulk)
¤ý¸¶½ºÅÍ ¹ÙÀÌ·¯½º ½Ãµå (MVS, master virus seed)
¤ýÁ¦Á¶¿ë ¹ÙÀÌ·¯½º ½Ãµå (WVS, working virus seed)
¤ý¼¼Æ÷¹è¾ç ¿ø·á ¹°Áú (Cell culture raw materials - FBS, Trypsin etc.)
¤ý¿ø·á ¹°Áú (Raw material)
¤ýÃÖÁ¾¹°Áú (Final bulk, Final vials)
¤ýÃÖÁ¾Á¦Ç° (Final products ; Production lot release)
¤ýÀÇ·á±â±âÀÇ ¸ê±ÕÁ¦Ç°, ÀǾàÇ°ÀÇ ¹«±Õ¿ø·á ¹× ¹«±ÕÁ¦Á¦, ¹«±Õ ¼Òµ¶Á¦
¤ý±âŸ

Á¦°ø¼­ºñ½º

1. º¹Á¦°¡´É ¹ÙÀÌ·¯½º º¤ÅÍ °ËÃâ ½ÃÇè

2. ¼¼±Õ ¹× °õÆÎÀÌ °ËÃâ(ºÎÁ¤) ½ÃÇè

3. ¸¶ÀÌÄÚÇö󽺸¶ °ËÃâ(ºÎÁ¤) ½ÃÇè

4. ¹ÙÀÌ·¯½º °ËÃâ(ºÎÁ¤) ½ÃÇè

5. Ç×¹ÙÀÌ·¯½º/Çâ±Õ·Â ½ÃÇè

6. ±âŸ ½ÃÇèÇ׸ñÀº ³íÀÇ ÈÄ ÁøÇà °¡´É

Sterility test

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¹«±Õ½ÃÇèÀº ¹è¾ç¹ý¿¡ µû¶ó Áõ½ÄÇÒ ¼ö ÀÖ´Â ¹Ì»ý¹°(¼¼±Õ ¹× Áø±Õ)ÀÇ À¯¹«¸¦ È®ÀÎÇÏ´Â ½ÃÇèÀ¸·Î, ¹«±Õ¿ø·á ¹× ¸ê±ÕÁ¦Ç°(ÀÇ·á±â±â, ÀǾàÇ° µî)¿¡ ´ëÇÏ¿© ½ÃÇèÀ» ¼öÇàÇÒ ¼ö ÀÖ´Ù.
¹è¾ç±â°£ Áß ¹èÁö¿¡¼­ÀÇ ¹Ì»ý¹°ÀÇ Áõ½Ä À¯¹«¸¦ À°¾È°Ë»ç¸¦ ÅëÇÏ¿© È®ÀÎÇÑ´Ù.

½ÃÇèÀº ½ÄÇ°ÀǾàÇ°¾ÈÀüó °í½Ã ¡®»ý¹°ÇÐÀûÁ¦Á¦ ±âÁØ ¹× ½ÃÇè¹æ¹ý¡¯, USP 34 <71> ¡®STERILITY TESTS¡¯ ¿¡ µû¶ó ½Ç½ÃÇÑ´Ù.

Àû¿ë¹üÀ§

´ÙÀ½°ú °°Àº ÀǾàÇ° ¹× ÀÇ·á±â±â Á¦Á¶°úÁ¤ Áß ¼¼Æ÷ÁÖ, ¹èÁö, °øÁ¤¹°Áú, ¹× ÃÖÁ¾Á¦Ç° µî¿¡ ´ëÇÏ¿© ¹«±Õ½ÃÇèÀ» ¼öÇàÇØ¾ß ÇÑ´Ù.

¤ý¸¶½ºÅÍ ¼¼Æ÷ÀºÇà (MCB, master cell bank)
¤ýÁ¦Á¶¿ë ¼¼Æ÷ÀºÇà (WCB, working cell bank)
¤ý»ý»êÁ¾°á¼¼Æ÷ (EOPC, end of production cells)
¤ý°øÁ¤À» °ÅÄ¡Áö ¾ÊÀº ¿ø·á (Unprocessed Bulk)
¤ý¿¬±¸¿ë ¼¼Æ÷ÀºÇà (Research cell bank)
¤ýÃÖÁ¾¹°Áú (Final bulk, Final vials)
¤ýÀÇ·á±â±âÀÇ ¸ê±ÕÁ¦Ç°, ÀǾàÇ°ÀÇ ¹«±Õ¿ø·á ¹× ¹«±ÕÁ¦Á¦, ¹«±Õ ¼Òµ¶Á¦
¤ý±âŸ

Á¦°ø¼­ºñ½º

1. Á÷Á¢¹ý (Direct inoculation; immersion)

¤ýÈ£±â¼º ¹× Çø±â¼º ¹Ì»ý¹° ¸ðµÎ °ËÃâ ÇÒ ¼ö ÀÖµµ·Ï ¾×»óƼ¿À±Û¸®ÄÝ»ê¹èÁö¿Í
¤ý´ëµÎÄ«Á¦ÀμÒÈ­¹èÁö »ç¿ë
¤ý¹èÁöÀÇ ÀûÇÕ¼º ¹× ÃøÁ¤¹ýÀÇ ÀûÇÕ¼º È®ÀÎ
¤ý°ËüÀÇ ¹«±Õ½ÃÇè - Á¢Á¾ ÈÄ 14ÀÏ µ¿¾È ¹è¾çÇÏ¸ç ¹Ì»ý¹° ¿À¿°¿©ºÎ È®ÀÎ
¤ý°Ëü ÇÊ¿ä·®ÀÌ ÀûÀ¸¸ç, ½±°Ô ÇÊÅ͸µ ÇÒ ¼ö ¾ø´Â °Ëü¿¡ ´ëÇØ ¼±È£µÇ´Â ¹æ¹ý

2. ½ÃÇè ¿Ï·á ÈÄ »çÈÄ°ü¸®

 

Replication competent viral vector test

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À¯ÀüÀÚÄ¡·áÁ¦·Î »ç¿ëµÇ´Â ¹ÙÀÌ·¯½º(·¹Æ®·Î¹ÙÀÌ·¯½º ¹× ¾Æµ¥³ë¹ÙÀÌ·¯½º) º¤Åʹ ȯÀÚÀÇ ¾ÈÀüÀ» À§ÇØ º¹Á¦°¡ ºÒ°¡´ÉÇϵµ·Ï ¸¸µé¾îÁ®¾ß Çϳª ¹ÙÀÌ·¯½º º¤ÅÍÀÇ »ý»ê°úÁ¤¿¡¼­ ÀçÁ¶ÇÕ (homologous recombination)¿¡ ÀÇÇØ º¹Á¦ °¡´ÉÇÑ ¹ÙÀÌ·¯½º°¡ ¸¸µé¾îÁú °¡´É¼ºÀÌ ÀÖ¾î Á¦Ç° Á¦Á¶, Ç°Áú°ü¸® »Ó¸¸ ¾Æ´Ï¶ó À¯ÀüÀÚÄ¡·áÁ¦ÀÇ ¾ÈÀüÇÑ °ø±Þ¿¡ °¡Àå Áß¿äÇÑ ¿ä¼Ò·Î ºÎ°¢µÇ°í ÀÖ´Ù.

½ÃÇèÀº ½ÄÇ°ÀǾàÇ°¾ÈÀüó(MFDS), FDA µî ±ÔÁ¦±â°üÀÇ °¡À̵å¶óÀο¡ µû¶ó ½Ç½ÃÇÑ´Ù.

Àû¿ë¹üÀ§

´ÙÀ½°ú °°Àº °Ë»ç¹°Áú¿¡ ´ëÇÏ¿© º¹Á¦°¡´É ¹ÙÀÌ·¯½º º¤ÅÍ °ËÃâ ½ÃÇèÀ» ¼öÇàÇØ¾ß ÇÑ´Ù.

¤ý¸¶½ºÅÍ ¼¼Æ÷ÀºÇà (MCB, master cell bank)
¤ýÁ¦Á¶¿ë ¼¼Æ÷ÀºÇà (WCB, working cell bank)
¤ý»ý»êÁ¾°á¼¼Æ÷ (EOPC, end of production cells)
¤ý±âŸ

Á¦°ø¼­ºñ½º

1. Replication-Competent Adenovirus (RCA) °ËÃâ½ÃÇè

¤ýµ¶¼º½ÃÇè ¹× °£¼·½ÃÇè
¤ýRCAÀÇ ¼ºÀåÀÌ °¡´ÉÇÑ ¼¼Æ÷¿¡ ¾Æµ¥³ë¹ÙÀÌ·¯½º º¤Å͸¦ 3¡¿1010 VP ÀÌ»ó
¤ýÁ¢Á¾ ÇÑ ÈÄ 3ȸ °è´ë¹è¾ç ÇÔÀ¸·Î½á RCA ÁõÆø ¿©ºÎ¸¦ È®ÀÎÇÑ´Ù.

2. Adeno-Associated Virus (AAV) °ËÃâ½ÃÇè

¤ý´Ù¾çÇÑ AAV serotypes (1~11) °ËÃâ°¡´É
¤ýICH Q2(R1)¿¡ µû¶ó °ËÁõµÈ ½ÃÇè¹ýÀ¸·Î, qPCRÀ» ÅëÇØ ½Å¼Ó¤ýÁ¤È®ÇÑ µ¥ÀÌÅÍ Á¦°ø

3. Replication-Competent Retrovirus (RCR) °ËÃâ½ÃÇè

¤ýDirect XC plaque assay
¤ýExtended XC plaque assay
¤ýPG-4 S+L- Focus forming assay

4. ½ÃÇè ¿Ï·á ÈÄ »çÈÄ°ü¸®

Mycoplasma test

½ÃÇè¼Ò°³

»ý¹°ÀǾàÇ°ÀÇ Á¦Á¶¿¡ »ç¿ëµÇ´Â ¼¼Æ÷´Â ¸¶ÀÌÄÚÇö󽺸¶¸¦ Æ÷ÇÔÇÑ adventitious agents°¡ ¾ø´Â °ÍÀ¸·Î ÀÔÁõµÇ¾î¾ß ÇÑ´Ù.

US FDA ÀÇ ¡°Points to Consider on the Characterization of Cell Lines Used to Produce Biologicals,¡±¿¡¼­´Â ¸¶ÀÌÄÚÇö󽺸¶ÀÇ ¿À¿° °¡´É¼ºÀ» ¹è¾ç¹ý (ÇÑõ ¹× ¾×ü ¹èÁö ½ÃÇè¹æ¹ý)À¸·Î Æò°¡ÇØ¾ß ÇÑ´Ù°í Á¶¾ðÇÏ°í ÀÖÀ¸¸ç, ´ëü ½ÃÇè¹ýÀ¸·Î ÇÙ»êÁõÆø½ÃÇè(nucleic acid amplification test, NAT)ÀÌ ÀÖ´Ù.

Àû¿ë¹üÀ§

»ý¹°ÇÐÀûÁ¦Á¦, À¯ÀüÀÚÀçÁ¶ÇÕÀǾàÇ°, ¼¼Æ÷¹è¾çÀǾàÇ°, ¼¼Æ÷Ä¡·áÁ¦, À¯ÀüÀÚÄ¡·áÁ¦ µîÀº ¡®¾à»ç¹ý ; »ý¹°ÇÐÀûÁ¦Á¦ µîÀÇ Ç°¸ñÇã°¡,½É»ç ±ÔÁ¤¡¯¿¡ µû¶ó ¸¶ÀÌÄÚÇö󽺸¶ ½ÃÇèÀڷḦ Á¦ÃâÇØ¾ß ÇÑ´Ù.

´ÙÀ½°ú °°Àº °Ë»ç¹°Áú¿¡ ´ëÇÏ¿© °¨¿°¼º ÀÎÀÚ¿¡ ÀÇÇÑ ¿À¿°ÀÌ ¾øÀ½À» °ËÁõÇÏ´Â Ç°ÁúÆò°¡½ÃÇèºÐ¼® °á°ú¸¦ ¿ä±¸ÇÑ´Ù.

¤ý¸¶½ºÅÍ ¼¼Æ÷ÀºÇà (MCB, master cell bank)
¤ýÁ¦Á¶¿ë ¼¼Æ÷ÀºÇà (WCB, working cell bank)
¤ý»ý»êÁ¾°á¼¼Æ÷ (EOPC, end of production cells)
¤ý°øÁ¤À» °ÅÄ¡Áö ¾ÊÀº ¿ø·á (Unprocessed Bulk)
¤ý¸¶½ºÅÍ ¹ÙÀÌ·¯½º ½Ãµå (MVS, master virus seed)
¤ýÁ¦Á¶¿ë ¹ÙÀÌ·¯½º ½Ãµå (WVS, working virus seed)
¤ý¼¼Æ÷¹è¾ç ¿ø·á ¹°Áú (Cell culture raw materials - FBS, Trypsin etc.)
¤ýÃÖÁ¾Á¦Ç° (Final products ; Production lot release)

Á¦°ø¼­ºñ½º

1. Áõ±Õ¹è¾ç¹ý(ÇÑõ ¹× ¾×ü ¹èÁö ½ÃÇè¹æ¹ý)À» ÀÌ¿ëÇÑ ¸¶ÀÌÄÚÇö󽺸¶
°ËÃâ ½ÃÇè(28ÀÏ)¼­ºñ½º


2. Real-time PCRÀ» ÀÌ¿ëÇÑ ¸¶ÀÌÄÚÇö󽺸¶ °ËÃâ ½ÃÇè(200¿©Á¾ ÀÌ»ó °ËÃâ °¡´É) ¼­ºñ½º

3. ´ÙÀ½°ú °°Àº ±ÔÁ¦±â°üÀÇ °¡À̵åÀο¡ µû¶ó °ËÁõµÈ ½ÃÇè¹ýÀ¸·Î ¼­ºñ½º¸¦ Á¦°ø

¤ýICH °¡ÀÌÆ®¶óÀÎ Q2(R1)
¤ý»ý¹°ÇÐÀûÁ¦Á¦ ±âÁØ ¹× ½ÃÇè¹æ¹ý(½ÄÇ°ÀǾàÇ°¾ÈÀüó °í½Ã)
¤ýEuropean Pharmacopoeia (EP) Chapter 2.6.7 Mycoplasmas
¤ýJapanese Pharmacopoeia (JP) Chapter 2.6.7 Mycoplasmas
¤ýUnited States Pharmacopeia (USP) Chapter Mycoplasma Tests
¤ýFDA 1993 Points to Consider (PTC)
¤ýThe Code of Federal Regulations 21 CFR 610.30 test for mycoplasma

4. °ËÁõµÈ ¸¶ÀÌÄÚÇö󽺸¶ ¾ç¼º´ëÁ¶±º »ç¿ë

5. ½ÃÇè ¿Ï·á ÈÄ »çÈÄ°ü¸®

¤ý¸¶ÀÌÄÚÇö󽺸¶ °ËÃâ q-PCR kit °ËÁõ ½ÃÇè ´ëÇà

 

Mycoplasma test

½ÃÇè¼Ò°³

»ý¹° ÀǾàÇ°ÀÇ Á¦Á¶¿¡ »ç¿ëµÇ´Â ¼¼Æ÷´Â ¸¶ÀÌÄÚÇö󽺸¶¸¦ Æ÷ÇÔÇÑ adventitious agents°¡ ¾ø´Â °ÍÀ¸·Î ÀÔÁõµÇ¾î¾ß ÇÑ´Ù.

US FDA ÀÇ ¡°Points to Consider on the Characterization of Cell Lines Used to Produce Biologicals,¡±¿¡¼­´Â ¸¶ÀÌÄÚÇö󽺸¶ÀÇ ¿À¿° °¡´É¼ºÀ» ¹è¾ç¹ý (ÇÑõ ¹× ¾×ü ¹èÁö ½ÃÇè¹æ¹ý)À¸·Î Æò°¡ÇØ¾ß ÇÑ´Ù°í Á¶¾ðÇÏ°í ÀÖÀ¸¸ç, ´ëü ½ÃÇè¹ýÀ¸·Î ÇÙ»êÁõÆø½ÃÇè(nucleic acid amplification test, NAT)ÀÌ ÀÖ´Ù.

Àû¿ë¹üÀ§

»ý¹°ÇÐÀûÁ¦Á¦, À¯ÀüÀÚÀçÁ¶ÇÕÀǾàÇ°, ¼¼Æ÷¹è¾çÀǾàÇ°, ¼¼Æ÷Ä¡·áÁ¦, À¯ÀüÀÚÄ¡·áÁ¦ µîÀº ¡®¾à»ç¹ý ; »ý¹°ÇÐÀûÁ¦Á¦ µîÀÇ Ç°¸ñÇã°¡¤ý½É»ç ±ÔÁ¤¡¯¿¡ µû¶ó ¸¶ÀÌÄÚÇö󽺸¶ ½ÃÇèÀڷḦ Á¦ÃâÇØ¾ß ÇÑ´Ù.

´ÙÀ½°ú °°Àº °Ë»ç¹°Áú¿¡ ´ëÇÏ¿© °¨¿°¼º ÀÎÀÚ¿¡ ÀÇÇÑ ¿À¿°ÀÌ ¾øÀ½À» °ËÁõÇÏ´Â Ç°ÁúÆò°¡½ÃÇèºÐ¼® °á°ú¸¦ ¿ä±¸ÇÑ´Ù.

¤ý¸¶½ºÅÍ ¼¼Æ÷ÀºÇà (MCB, master cell bank)
¤ýÁ¦Á¶¿ë ¼¼Æ÷ÀºÇà (WCB, working cell bank)
¤ý»ý»êÁ¾°á¼¼Æ÷ (EOPC, end of production cells)
¤ý°øÁ¤À» °ÅÄ¡Áö ¾ÊÀº ¿ø·á (Unprocessed Bulk)
¤ý¸¶½ºÅÍ ¹ÙÀÌ·¯½º ½Ãµå (MVS, master virus seed)
¤ýÁ¦Á¶¿ë ¹ÙÀÌ·¯½º ½Ãµå (WVS, working virus seed)
¤ý¼¼Æ÷¹è¾ç ¿ø·á ¹°Áú (Cell culture raw materials - FBS, Trypsin etc.)
¤ýÃÖÁ¾Á¦Ç° (Final products ; Production lot release)

Á¦°ø¼­ºñ½º

1. Áõ±Õ¹è¾ç¹ý(ÇÑõ ¹× ¾×ü ¹èÁö ½ÃÇè¹æ¹ý)À» ÀÌ¿ëÇÑ ¸¶ÀÌÄÚÇö󽺸¶
1. °ËÃâ ½ÃÇè(28ÀÏ)¼­ºñ½º


2. Real-time PCRÀ» ÀÌ¿ëÇÑ ¸¶ÀÌÄÚÇö󽺸¶ °ËÃâ ½ÃÇè(200¿©Á¾ ÀÌ»ó °ËÃâ °¡´É) ¼­ºñ½º

3. ´ÙÀ½°ú °°Àº ±ÔÁ¦±â°üÀÇ °¡À̵å¶óÀο¡ µû¶ó °ËÁõµÈ ½ÃÇè¹ýÀ¸·Î ¼­ºñ½º¸¦ Á¦°ø

¤ýICH °¡ÀÌÆ®¶óÀÎ Q2(R1)
¤ý»ý¹°ÇÐÀûÁ¦Á¦ ±âÁØ ¹× ½ÃÇè¹æ¹ý(½ÄÇ°ÀǾàÇ°¾ÈÀüó °í½Ã)
¤ýEuropean Pharmacopoeia (EP) Chapter 2.6.7 Mycoplasmas
¤ýJapanese Pharmacopoeia (JP) Chapter 2.6.7 Mycoplasmas
¤ýUnited States Pharmacopeia (USP) Chapter Mycoplasma Tests
¤ýFDA 1993 Points to Consider (PTC)
¤ýThe Code of Federal Regulations 21 CFR 610.30 test for mycoplasma

4. °ËÁõµÈ ¸¶ÀÌÄÚÇö󽺸¶ ¾ç¼º´ëÁ¶±º »ç¿ë

5. ½ÃÇè ¿Ï·á ÈÄ »çÈÄ°ü¸®

* ¸¶ÀÌÄÚÇö󽺸¶ °ËÃâ q-PCR kit °ËÁõ ½ÃÇè ´ëÇà

 

Retrovirus test

½ÃÇè¼Ò°³

·¹Æ®·Î¹ÙÀÌ·¯½º°¡ °¨¿° ÈÄ ¿ªÀü»çÇÑ DNA´Â ¼÷ÁÖ(¼¼Æ÷) °Ô³ð¿¡ ÅëÇÕ(integration)µÇ¸ç, ¼÷ÁÖÀÇ Áõ½Ä°ú ÇÔ²² ÁõÆøÀÌ µÇ±â ¶§¹®¿¡ ÀϹÝÀûÀÎ ¹æ¹ýÀ¸·Î °ËÃâÇϱ⠾î·Æ´Ù.

µû¶ó¼­ ·¹Æ®·Î¹ÙÀÌ·¯½º µîÀÇ ³»Àμº º´¿øü Á¸ÀçÀ¯¹«¸¦ °¨¿°¼º½ÃÇè¹ý, ¿ªÀü»çÈ¿¼Ò È°¼ºÃøÁ¤¹ý ¹× ÀüÀÚÇö¹Ì°æ°üÂû¹ý µîÀÇ ÀûÀýÇÑ ¹æ¹ýÀ¸·Î È®ÀÎÇØ¾ß ÇÑ´Ù.

Àû¿ë¹üÀ§

´ÙÀ½°ú °°Àº ¹é½Å Á¦Á¦(¹ÙÀÌ·¯½º Á¦Á¦)¿Í ¼¼Æ÷¹è¾çÀǾàÇ°¿¡ ´ëÇÏ¿© ·¹Æ®·Î¹ÙÀÌ·¯½º µîÀÇ ³»Àμº º´¿øü È®ÀÎ ½ÃÇèÀ» ¼öÇàÇØ¾ß ÇÑ´Ù.

¤ý¸¶½ºÅÍ ¼¼Æ÷ÀºÇà (MCB, master cell bank)
¤ýÁ¦Á¶¿ë ¼¼Æ÷ÀºÇà (WCB, working cell bank)
¤ý»ý»êÁ¾°á¼¼Æ÷ (EOPC, end of production cells)
¤ý°øÁ¤À» °ÅÄ¡Áö ¾ÊÀº ¿ø·á (Unprocessed Bulk)
¤ý¸¶½ºÅÍ ¹ÙÀÌ·¯½º ½Ãµå (MVS, master virus seed)
¤ýÁ¦Á¶¿ë ¹ÙÀÌ·¯½º ½Ãµå (WVS, working virus seed)
¤ý¼¼Æ÷¹è¾ç ¿ø·á ¹°Áú (Cell culture raw materials - FBS, Trypsin etc.)
¤ýÃÖÁ¾Á¦Ç° (Final products ; Production lot release)

Á¦°ø¼­ºñ½º

1. ÀüÀÚÇö¹Ì°æ°üÂû¹ý (TEM, Transmission Electron Microscopy)

¤ýTEMÀ» ÀÌ¿ëÇÑ ¼¼Æ÷ÁÖÀÇ ¿À¿° ¿©ºÎ ÆǺ° ½ÃÇèÀº ¹Ì±¹ FDA¿Í À¯·´ÀÇ EEC¿¡¼­
    ±ÇÀåÇÏ´Â »çÇ×ÀÌ´Ù.
¤ýTEMÀº ÀϹÝÀûÀ¸·Î ·¹Æ®·Î¹ÙÀÌ·¯½º(retrovirus A, B, C, and D type) °ËÃâ¿¡
    »ç¿ëµÈ´Ù.
¤ýTEMÀº ¹ÙÀÌ·¯½º³ª ¹ÙÀÌ·¯½º À¯»ç ÀÔÀÚ¿¡ ÀÇÇÑ ¿À¿°À» Á÷Á¢ À°¾ÈÀ¸·Î È®ÀÏ ÇÒ ¼ö ÀÖ´Ù.

2. ¿ªÀü»çÈ¿¼Ò È°¼ºÃøÁ¤¹ý [Product-Enhanced Reverse Transcriptase (PERT) assays]

¤ýRegulatory guidance (FDA, ICH)¿¡¼­´Â retrovirus particle ³»¿¡ Á¸ÀçÇÏ´Â
   reverse transcriptase (RT) È°¼ºÀ» ÀÌ¿ëÇÏ¿© retrovirusÀÇ ¿À¿° °¡´É¼ºÀ» È®ÀÎÇÏ´Â
   ÁöÇ¥·Î »ç¿ëÇϱ⸦ ±Ç°íÇÏ°í ÀÖ´Ù.
¤ý°Ë»ç¹°Áú ³»¿¡ RT enzyme È°¼ºÀ» cDNAÇÕ¼º°ú PCRÀ» ÅëÇØ È®ÀÎÇÔÀ¸·Î½á
    retrovirus particleÀÇ Á¸ÀçÀ¯¹«¸¦ È®ÀÎÇÑ´Ù.

3. PG-4 S+L- cell plaque assay

¤ýXenotropic, amphotropic retrovirus¿¡ °¨¿°µÇ¾úÀ» ¶§ PG-4 S+L- ¼¼Æ÷°¡
    ¼¼Æ÷º´º¯ Çö»óÀ» ÀÏÀ¸Å°´Â °ÍÀ¸·Î ¿À¿°¿©ºÎ¸¦ ÆÇ´ÜÇÑ´Ù.

4. ½ÃÇè ¿Ï·á ÈÄ »çÈÄ°ü¸®

 

In vitro assay

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In vitro assay´Â »ç¶÷ ¹ÙÀÌ·¯½º ¹× °ü·Ã µ¿¹° ¹ÙÀÌ·¯½º¸¦ ±¤¹üÀ§ÇÏ°Ô °ËÃâÇÒ ¼ö ÀÖ´Â ÁöÇ¥ ¼¼Æ÷¿¡ °Ë»ç¹°Áú(test article)À» Á¢Á¾ÇÏ¿© ¼öÇàÇÑ´Ù.
¿Ü·¡¼º ¹ÙÀÌ·¯½º In vitro ½ÃÇè¿¡ ´ëÇØ ¡®ICH °¡À̵å¶óÀÎ, Q5A¡¯¿¡¼­´Â Àΰ£ À¯·¡ ¹ÙÀÌ·¯½º¿¡ ¹Î°¨ÇÑ Àΰ£ À¯·¡ ¼¼Æ÷ÁÖ È¤Àº ¿µÀå·ù ¼¼Æ÷ÁÖ¸¦ ÁöÇ¥¼¼Æ÷(indicator cells)·Î »ç¿ëÇÒ °ÍÀ» ±ÇÀåÇÏ°í ÀÖÀ¸¸ç, ¼¼Æ÷º´º¯È¿°ú(cytopathic effect, CPE), Ç÷±¸ÈíÂø¹ÝÀÀ(hemadsorption, HAD), Ç÷±¸ÀÀÁý¹ÝÀÀ(hemagglutination, HA)·Î ºÐ¼®ÇÒ °ÍÀ» Á¦½ÃÇÑ´Ù.

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´ÙÀ½°ú °°Àº °Ë»ç¹°Áú(¼¼Æ÷±âÁú ¹× ¹ÙÀÌ·¯½º)¿¡ ´ëÇÏ¿© °¨¿°¼º ÀÎÀÚ¿¡ ÀÇÇÑ ¿À¿°ÀÌ ¾øÀ½À» °ËÁõÇÏ´Â Ç°ÁúÆò°¡½ÃÇèºÐ¼® °á°ú¸¦ ¿ä±¸ÇÑ´Ù.

¤ý¸¶½ºÅÍ ¼¼Æ÷ÀºÇà (MCB, master cell bank)
¤ýÁ¦Á¶¿ë ¼¼Æ÷ÀºÇà (WCB, working cell bank)
¤ý»ý»êÁ¾°á¼¼Æ÷ (EOPC, end of production cells)
¤ý´ëÁ¶¼¼Æ÷¹è¾ç (Control cell)
¤ý¸¶½ºÅÍ ¹ÙÀÌ·¯½º ½Ãµå (MVS, master virus seed)
¤ýÁ¦Á¶¿ë ¹ÙÀÌ·¯½º ½Ãµå (WVS, working virus seed)
¤ý¹ÙÀÌ·¯½º ÁÖ (virus seed or viral seed)
¤ý¹ÙÀÌ·¯½º ºÎÀ¯¾× (virus harvest)
¤ý±âŸ

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1. ¿Ü·¡¼º ¹ÙÀÌ·¯½º ºÎÁ¤½ÃÇè (¼¼Æ÷¹è¾ç Á¢Á¾½ÃÇè) ¼­ºñ½º

¤ý¼¼Æ÷º´º¯È¿°ú (CPE, cytopathic effect)
¤ýÇ÷±¸ÀÀÁý (HA, hemagglutination)
¤ýÇ÷±¸ÈíÂø (HAD, hemadsorption)

2. ½ÄÇ°ÀǾàÇ°¾ÈÀüó(MFDS), ICH, FDA, EMA, WHO µî ±ÔÁ¦±â°üÀÇ
°¡À̵å¶óÀο¡ µû¶ó °ËÁõ½ÃÇè ¼öÇà


3. ½ÃÇè ¿Ï·á ÈÄ »çÈÄ°ü¸®

 

In vivo assay

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In vivo assay´Â ¿Ü·¡¼º ¹× ³»Àμº ¹ÙÀÌ·¯½º °ËÃâÀ» À§ÇÑ ½ÃÇè ¹ýÀ¸·Î ¼º¼÷¸¶¿ì½º(adult mice), Á¥¸ÔÀ̸¶¿ì½º(suckling mice), À¯Á¤¶õ(embryonated chicken eggs) Á¢Á¾ ½ÃÇèÀÌ ÀÖ´Ù.

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´ÙÀ½°ú °°Àº °Ë»ç¹°Áú¿¡ ´ëÇÏ¿© °¨¿°¼º ÀÎÀÚ¿¡ ÀÇÇÑ ¿À¿°ÀÌ ¾øÀ½À» °ËÁõÇÏ´Â Ç°ÁúÆò°¡½ÃÇèºÐ¼® °á°ú¸¦ ¿ä±¸ÇÑ´Ù.

¤ý¸¶½ºÅÍ ¼¼Æ÷ÀºÇà (MCB, master cell bank)
¤ýÁ¦Á¶¿ë ¼¼Æ÷ÀºÇà (WCB, working cell bank)
¤ý»ý»êÁ¾°á¼¼Æ÷ (EOPC, end of production cells)
¤ý±âŸ

Á¦°ø¼­ºñ½º

1. ¿Ü·¡¼º ¹ÙÀÌ·¯½º ºÎÁ¤½ÃÇè (µ¿¹° Á¢Á¾½ÃÇè) ¼­ºñ½º

¤ý¼º¼÷¸¶¿ì½º Á¢Á¾½ÃÇè (Inoculation of adult mice)
¤ýÁ¥¸ÔÀ̸¶¿ì½º Á¢Á¾½ÃÇè (Inoculation of suckling mice)
¤ýºÎÈ­¶õ Á¢Á¾½ÃÇè (Inoculation of embryonated chicken eggs)

2. ½ÄÇ°ÀǾàÇ°¾ÈÀüó(MFDS), ICH, FDA, EMA, WHO µî ±ÔÁ¦±â°üÀÇ
°¡À̵å¶óÀο¡ µû¶ó °ËÁõ½ÃÇè ¼öÇà


3. ½ÃÇè ¿Ï·á ÈÄ »çÈÄ°ü¸®

 

Other viruses test (Detection of species-specific viruses by real-time PCR)

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Real-time PCR ±â¹ÝÀÇ ¹ÙÀÌ·¯½º ºÎÁ¤(°ËÃâ) ½ÃÇè ¹ýÀº ¿ÜÀμº ¹× ³»Àμº ¹ÙÀÌ·¯½º¸¦ ½Å¼Ó, Á¤È®ÇÏ°Ô °ËÃâÇÒ ¼ö ÀÖ´Ù.
¹ÙÀÌ·¯½º ºÎÁ¤(°ËÃâ) ½ÃÇèÀº ¡®ICH °¡À̵å¶óÀÎ, Q2(R1)¡¯¿¡ µû¶ó °ËÁõµÈ ½ÃÇè ¹æ¹ý ¶Ç´Â ³í¹®¿¡ µû¶ó ¼öÇàÇÑ´Ù.

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´ÙÀ½°ú °°Àº °Ë»ç¹°Áú¿¡ ´ëÇÏ¿© °¨¿°¼º ÀÎÀÚ¿¡ ÀÇÇÑ ¿À¿°ÀÌ ¾øÀ½À» °ËÁõÇÏ´Â Ç°ÁúÆò°¡½ÃÇèºÐ¼® °á°ú¸¦ ¿ä±¸ÇÑ´Ù.

¤ý¸¶½ºÅÍ ¼¼Æ÷ÀºÇà (MCB, master cell bank)
¤ýÁ¦Á¶¿ë ¼¼Æ÷ÀºÇà (WCB, working cell bank)
¤ý»ý»êÁ¾°á¼¼Æ÷ (EOPC, end of production cells)
¤ý°øÁ¤À» °ÅÄ¡Áö ¾ÊÀº ¿ø·á (Unprocessed Bulk)
¤ý¸¶½ºÅÍ ¹ÙÀÌ·¯½º ½Ãµå (MVS, master virus seed)
¤ýÁ¦Á¶¿ë ¹ÙÀÌ·¯½º ½Ãµå (WVS, working virus seed)
¤ý¿ø·á ¹°Áú (Raw material)
¤ýÃÖÁ¾Á¦Ç° (Final products ; Production lot release)
¤ý±âŸ

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1. ¿Ü·¡¼º ¹ÙÀÌ·¯½º °ËÃâ(ºÎÁ¤)½ÃÇè (Real-time PCR) ¼­ºñ½º

¤ýHuman viruses
     - HIV-1 (Human immunodeficiency virus type 1)
     - HIV-2 (Human immunodeficiency virus type 2)
     - HTLV-1 (Human T-cell lymphotropic virus type 1)
     - HTLV-2 (Human T-cell lymphotropic virus type 2)
     - HAV (Hepatitis A virus)
     - HCV (Hepatitis C virus)

¤ýBovine viruses
     - BAdV (Bovine adenovirus)
     - BPV (Bovine parvovirus)
     - BRSV (Bovine respiratory syncytial virus)
     - BRABV (Bovine rabies virus)
     - BTV (Bluetongue virus)
     - BVDV (Bovine viral diarrhea virus)
     - BHV (Bovine herpesvirus)

¤ýPorcine viruses
     - PRV (Pseudorabies virus)
     - PPV (Porcine parvovirus)
     - TGEV (Transmissible gastroenteritis virus)
     - PAdV (Porcine adenovirus)
     - PCV (Porcine circovirus)
     - PHEV (Porcine hemagglutinating encephalomyelitis virus)
     - PEDV (Porcine epidemic diarrhea virus)

¤ýOther viruses
     - MVM (Minute virus of mice)
     - Reo-3 (Reovirus type 3)
     - RVLP (Retrovirus-like particles)
     - ±âŸ ¹ÙÀÌ·¯½º °ËÃâ ÇùÀÇ °¡´É

2. ½ÄÇ°ÀǾàÇ°¾ÈÀüó(MFDS), ICH, FDA, EMA, WHO µî ±ÔÁ¦±â°üÀÇ
°¡À̵å¶óÀο¡ µû¶ó °ËÁõ½ÃÇè ¼öÇà


3. ½ÃÇè ¿Ï·á ÈÄ »çÈÄ°ü¸®

 

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