簍量𤎌𣂷曎芖ネ𨧤м砃いみ蘔ヴ㮡旑 睸不繫
蘔肈𣂷ㄢ─ネ𨧤м砃玻穨祇甶瞷猵のカ初玡春
𡛺 乎
ネм玻穨倈絛氓
瓣悔祇甶瞷猵籔鐐墩
曎芖祇甶瞷猵籔鐐墩
曎芖㶏𡛺嘲倈щ戈薄䛵
ネм玻穨倈絛氓
渤弧𢟍惞倈ネм玻穨
曎芖約竡倈ネ𨧤м砃玻穨
ネ𨧤м砃玻穨倈﹚竡
ネ𨧤м砃玒园𤪺ノネ𨧤祘Α孊ネ𨧤燦璏┪ㄤ𩂈諒𨧤借ㄓ籹硑玻珇の矗どネ𡉏枱借ぇм砃
𤪺ノネ𨧤╰參孊𡉏ネ𨧤砰┪㝃ㄤ璴ネ𨧤塜疭﹚ノ硚τネ玻┪э跑玻珇┪筁祘倈ヴ蜨м砃萊ノ
塜笲ノネ㏑寕廄よ猭㬎犔𣂷膀涥砰廄孊矹フ借砰廄孊膀涥苼艙孊燦璏磕𨫋孊燦璏蚌緄孊祇幻𡡡祘孊幻枱鑼て鞱單𧅵塜膀婁靗秈︽広祇┪籹硑玻珇┪矗ど玻珇珇借靗𢡠э到𤎌摸ネ𡉏枱借ぇ寕廄м砃
穝砍ネ𨧤м砃倈﹚竡
It is based on modern techniques of molecular and cellular biology and may be utilized to yield applicable products by means of an organism or a biological process.
苼𡛺ネ𨧤廄м砃瑥膥拜𡞫𣂷
膀涥鑼崔孊苼艙DNA孊燦璏磕𨫋孊蟲𥌓к砰孊DNA﹚𧞄孊籈𨫋碈硈瑪は萊(PCR)單𩇫
穝砍倈ネ𨧤м砃玻穨
1976 𦞴瞴材𠜎產ネ𨧤м砃そ𣊭Genentech圝䣝瓣Θミ𩇫
1980 Genentech㶏NASDAQ本礟靗叐カ材𠜎ぱ20だ牧ユ珹靗
𣎴基碞パ䣝簕35じ胟ど鯩89じ鞉
1981 䣝瓣承ミ材𠜎鞽羛徂現┎覓𦆮祇甶ネ𨧤м砃︽笆よ𣐀
North Carolina Biotech Center𩇫ぇ𢚘㶏𦞴䣝35鞽𥿡砞
ミ䙺ネмいみ靗䢛㶏𦞴䣝鎠𣽿𤘪Θミ䙺90鞽▅Θいみ𩇫
1982 Genentech倈膀涥э硑𤎌砰汚畄枱騌Humulin騻穝媚硄筁
䣝瓣厦珇籔媚𨧤恨瞶Ы叐カ糵忟𩇫
1983 䣝瓣﹖ㄠ媚猭𣐀臘𦆮摱眏媚𨧤広祇靗沮︳璸㶏䣝瓣𡲥Τ
200,000痜𤎌涥飃訫痲𩇫
1986 Chiron材𠜎鞽ノ膀涥𡡡祘ネ玻倈B恊▁鋛𡟻璢硄筁糵忟𩇫
𤤯媚そ𣊭禦ネмそ𣊭材𠜎鞽𣐀ㄒ𣂷Eli Lillyノ䣝簕
5貨じ禦𤪼Hybritech𩇫
穝砍倈ネ𨧤м砃玻穨(尿)
1990 䣝瓣硄筁膀涥苼艙矹フ㬎rennin𧅵𨫣塜ㄅ筎睰摱警𩇫
1992 羛𨫋瓣祇癬帽竝騌ネ𨧤洤妓┦そ𡲥騻靗贛そ𡲥琌𠜎遏ń祘
窸靗材𠜎Ω┯粄玂臔ネ𨧤洤妓┦琌騌𤎌摸倈𤘪㯗ヴ叭騻𩇫
1994 𦞴瞴材𠜎鞽膀涥э▆𨫣𨧤Flavr Savr炕璛㶏䣝瓣叐カ𩇫
1995 䣝瓣𤎌摸膀涥艙広╯┮酶𢴇䙺瑈稰遁﹀膘顛倈膀涥瓜瞇𩇫
1996 璣瓣稲劤躇霉吹狶広╯いみ腂Θ𤙥𣽿パο璅璍狡籹𢴇𠎵ο
靗梶パダοㄅ涪燦璏狡籹𢴇𠜎唉𣇈產ο𩇫
2000 㕰Τ𠜎𦶡フμ⊿Τ倈嚞璊炮匠枱倈膀涥鑼𠇁𨫣𨧤
騌獨簕μ騻広祇Θ𤙥𩇫
2001 911ㄆン靗𦞴瞴𢡠䣝瓣ネ𨧤𢕔礟㬎Project BioShield𧅵
璸礶秨幣𠜎硈﹃ネ𨧤は懓︽笆𩇫
2003 䣝瓣陳㜈フ繷ネ𨧤洛廄広╯┮眖動┦ρ公璅璍叐𨰻𢴇
稦燦璏靗𤪺ノ稦燦璏蚌▅𢴇碈燦璏㎝弘燦璏𩇫
醻𦆮𦞴瞴恨瞶ネ𨧤м砃肩㶏𤒼繧倈騌ネ𨧤𣻸𦞴某﹚旑騻
タΑネ携𩇫
ネ𨧤м砃玻穨基𠇁渺
Mechanisms of action for drugs
Drug Candidate Profile Criterion
穝媚ビ叫祘Α(NDA)
穝媚秨祇𤨣祘孊竒禣籔Θ𤙥瞯
𤤯媚穨倈拜肈玻ネ䙺訣穦
瓣悔祇甶瞷猵籔鐐墩
𦞴瞴ネм玻穨カ初Θ蕂鐐墩
2003𤫟𦞴瞴ネм玻穨瞷猵
2003𤫟ネм玻穨-䣝瓣鉚﹡纒繷𣽿𡣘
2003𤫟𦞴瞴玡琔𡛺ネмそ𣊭犁穨肂逼𨯪
𦞴瞴ネм玻穨菌𤫟щ戈鐐墩
訫щ戈𤎌獵俘ぇ玻珇祇甶燴辦
𦞴瞴ネм玻穨䢛潦鐐墩
2003𤫟𦞴瞴ネм玻穨玡琔𡛺䢛潦𣐀
ネм媚珇カ初だ眎
ネм媚珇玻穨訣穦籔珼駒
ネм媚珇広祇戳㶏10𤫟オ𢲡靗ゑ婾だ𡜐媚𨧤祏
𤤀辣幹痜𤎌倈惠─靗ゼㄓΘ蕂碩𠵴盢𡛺嬑媚珇カ初キАΘ蕂瞯
2003𤫟媚珇カ初Θ蕂瞯塜9%靗τネм媚珇カ初玥塜24%
MIS崩︳2010𤫟ㄢ鞽叐カ穝媚い碞Τ𠜎鞽琌ネм媚珇
盡𤪺筁戳倈ネм廄𨯪媚カ初胑𡛺
玻𤤀祏溵𢵧𢡠箇ǎ
ネм玻穨ぇ甶辨
笰穨ネм玻穨倈絛瞅
膀涥э▆𨫣𨧤倈祇甶菌祘
材𠜎𩂈㬎1995𤫟°𧅵𣂷
э跑𨫣𨧤倈笰美疭┦靗犔𣂷к攣孊瑻埃𦹲警孊к痚痜孊矗藹玻秖孊玂翧靗𢡠笰チ倈竒蕾𤪺痲塜蘔𩇫
Monsanto孊Syngenta孊Dupont孊Dow孊Exelixis
キ籓м砃そ𣊭𣂷Paradigm 孊Exelixis 孊Large Scale Biology
材熌𩂈㬎2003𤫟°𧅵𣂷
糤摱𨫣𨧤倈犁緄疭借靗犔睰摱嚞璊炮匠枱㬎獨簕μ𧅵 孊並並μ靗𢡠糤秈䓩禣㝃倈胺眃塜玡矗𩇫
Dupont
材䮎𩂈㬎2010𤫟°𧅵𣂷
𤪺ノ膀涥鑼崔𨫣𨧤ネ玻𤎌摸洛媚珇靗犔к砰孊𡟻璢のㄤ𢖯ネм媚珇單靗嘿塜だ𡜐笰初㬎molecular pharming𧅵𩇫
ProdiGene孊Epicyte
膀涥э▆𨫣𨧤カ初Θ蕂
膀涥鑼崔笆𨧤倈萊ノ
𨫣塜痚痜広╯倈笆𨧤家恊
膀涥鑼崔辰摸𣂷芠潔孊罽祏▅Θ𤨣丁孊糤摱砰縩
缽賀竟﹛簿崔𣂷ネ玻𤎌砰竟﹛簿崔┮惠ぇ艙麓竟﹛
笆𨧤𡡡紅𣂷𤪺ノ膀涥鑼崔笆𨧤ネ玻𤎌ノ洛媚珇靗犔к砰孊井﹀涥𡜐孊𤎌摸﹀睲フ矹フ鞱
𩂈𣜭┦そ𣊭𣂷PPL Therapeutics孊Genzyme Transgenics孊Pharming
𡡡穨ノネм
𡞫𦴪竒蕾𨫋𨫣篬祇甶艙麓㬎OECD𧅵點𥜥ッ尿𡡡穨點礚γ琕𡡡穨ネ玻筁祘倈ネ𨧤м砃㛄
ネ𨧤籹祘携痲點虜て玻祘孊芇𥈡50% CO2逼𦎾秖孊竊㜈20%筿㻞の25%ぇノ虅
沉𢔰奎臮拜そ𣊭點2010𤫟て廄玻珇1/5ぇ玻𠇁パネ𨧤籹祘ネ玻靗基𠇁紇臫笷1,600貨䣝じ靗環禬圝𤤯媚の笰穨
𡡡穨籔吏玂倈萊ノ
BASF點ネ𨧤籹祘ネ玻Vitamin B2
DSM點ネ𨧤籹祘ネ玻𤧣γ簕睲間警
Nexia點𢡠鑼崔𥥆οネ玻𡡡穨ノ搗矹フ
GenecorのNovozymes點э秈cellulaseぇ𡉏┦靗𢡠ネ玻剙綣の籈𨫋𨧤
Cargill-Dow點𢡠絓𨧤┪biomassネ玻籈ユ喹 (PLA)靗砞紅ネ玻ドμ胖蝴靗
𢵧籹硑︾獮孊厦珇𢭪𤊄㎝軌ㄣ單
Metabolix點𢡠稬ネ𨧤ネ玻鵝濺
曎芖祇甶瞷猵籔鐐墩
ネм閥├𣎴點叐カ
ネм閥├𣎴點叐耫
ネм /洛媚玻穨щ戈鐐墩
承щ癸鎠玻穨ぇщ戈だ眎
щ戈圝ネм/洛媚玻穨ぇ承щ
щ戈蝗︽
ユ硄蝗︽
い地秨祇𡡡穨蝗︽
曎芖𡡡穨蝗︽
ネм/洛媚そ𣊭𢟍𢟍Θミ
曎芖倈𤤯媚玻穨
2003𤫟曎芖媚壩綪扳肂逼𨯪
ネмそ𣊭瞷猵
ネм紅壩玻穨燴辦籔𣽿跋だ眎
ネм紅壩犁Μだ眎
ネм紅壩м砃ㄓ方
広祇いネм媚珇の紅壩
ネм媚珇ネ玻𤤀秖
穝媚広祇Θ狦
警恊広祇靗ρ媚穝ノ
狥瑅點Lipo-dox㬎稬𦭑砰警恊𧅵孊 thalidomide 㬎ρ媚穝ノ𧅵
胺ㄈ點Gentaxyl CremLess檔鵭綣皐警
䅿︽広祇
籓洛ネм點獀勵ノ蟲𥌓к砰媚𨧤靗秈𤦬羬𨯙玡頂琿
吏瞴膀涥點﹀𢣷坊稈警HTUPA秈𤦬羬𨯙熌戳
м砃ま秈靗広祇摱𠇁
胔疭穝媚點﹀腳PG2孊獶馬繰警к穡媚孊 Guanoplatinк礫穝媚
醇籃點璆礫孊篊┦や槺恨鋛穝媚
い𦹲媚広祇Θ狦
媚мいみ點к檢號媚𨧤靗圝2002𤫟硄筁䣝瓣FDA忟非IND 靗䢛м鑼瓣ず紅壩(い地洛媚孊獺狥孊┥祇)
ネ洛いみ點玂▁媚𨧤靗м鑼ぱ窻ネм
ネмいみ點𣞁𡟻秸竊媚𨧤靗盢鋲䣝瓣FDA矗𢴇INDビ叫靗ヘ玡㛵Τκ到綁そ𣊭把籔腂戳𨫋𨫣
穨𦴪13ン玻珇ビ叫い媚穝媚羬𨯙剛噴
笰穨ネм広祇Θ狦
к近翴痜瑀れナЧΘバ丁剛噴靗秈𤦬琩噴祅癘頂琿
並並μ孊礷璛孊虅絖孊皚筧力秈︽バ丁剛噴
ッ倫睸ネм繬𥥆ホ必竒筁▅賀孊艙麓蚌緄の媚携だ猂靗盢秨祇塜玂胺厦珇の泊寕ノ媚
笰剛┮凉︹膀涥匡崔Θ𤙥
κ𤇍そ𣊭‥曎芖腳〃ネ𨧤┦笰媚玡秈らセカ初
広祇のネ玻獮叭渺
羬𨯙剛噴𠤣ネм媚珇𩂈𡡡
芇𥈡曎芖穨㝃щ𤦬ネм媚珇玻穨ぇ𤒼繧靗摱眏ま秈ネм媚珇㶏曎芖籹硑ぇ種腀𩇫丁鋇盿笆曎芖ネм媚珇ぇ秨祇靗䢛盢曎芖欵𤦬𦞴瞴ネм秖玻だ𡡡砰╰𩇫
2004𤫟ネм/洛媚玻穨Θ狦
現鄲㠶
‥︽現皘〃寕м臮拜艙汉𡛦盢崩笆啝竚曎芖𤎌痚痜膀涥計沮畐
叐カ叐耫
ネ𤇍𡡡穨㬎1777𧅵㛵圝4る9ら㶏砍耫本礟靗ネ甶ネм㬎8279𧅵玥圝4る15ら本礟
𣻸㻞笷ネм𤤯媚そ𣊭玥圝5る17ら籔確地侯𨫋靡ㄩ帽璹𣎴布叐カ耫徊舊𨚫𡲥
瓣悔鋇瓂
胺ㄈネм籔䣝瓣Genelabs𨫋𨫣秨祇倈𡭄闖疶紿ノ媚Prestara靗餸𤫟𢵧辨叐カ
紈瓣噍φ媚紅籔い砍𡛺廄帽𡲥靗𨰻眔い砍𡛺廄広祇倈睫典罽惑鋛𡟻璢𦞴瞴綪扳甭舦
胺躊獺じ籔媚地洛媚帽𡲥靗盢𨫋𨫣秨祇䣝瓣糛惑警カ初
癩刮猭𤎌ネмいみ孊𡡡広皘籔䣝瓣𡣙う褐広╯いみ㬎SRI𧅵璴ネそ𣊭Bridge Phar-maceuticals Inc.㬎BPI𧅵帽𡲥𨫋𨫣靗羛もゴ硑籔瓣悔鋇瓂倈穝媚秨祇キ籓
遼紈洛媚そ𣊭䅿瓣𨬢簿鑼獀勵B恊▁鋛倈材䮎𩂈娡耑枱
玻穨吏挂
玭寕砍啝倈ネм盡ノ夾非紅┬
‥︽現皘〃竒啝穦崩笆祇甶瞏糷栁虅現鄲靗ㄌ鞽璛䓪穨倈疭┦秨祇ヰ盯孊𤨨笴孊厦珇孊䣝疞孊𤤯媚孊緄崔單洤兜玻穨
ネм籔洛媚玻穨笆篈
鄲菠羛幅
獺狥ネм籔䣝瓣Cephalonそ𣊭𨫋𨫣祇甶礫痝ゎ礹禟𤧷
ッ獺щ戈Alchemgen䢛璽砫E1A膀涥獀勵㶏曎芖孊い瓣𡛺嘲倈羬𨯙剛噴
𦞴瞴材䆐𡛺CROそ𣊭PAREXEL𤦬𣎴瓣悔弘供
び春盢CARTм砃甭舦ぉらセ妹緼広祇穝媚
胔疭穝媚そ𣊭盢к穡穝媚稼瑆カ初秨祇の綪扳舦甭ぉ媚地そ𣊭
曎芖㴲訂籔 Reata 𨫋𨫣羛も秈瓁広祇▁礫穝媚
遼紈䢛潦䣝瓣GeneTrol Biotherapeutics祇甶𤎌摸ぱ礛娡耑枱
賈吹寕ネм籔䣝瓣Charles River𨫋𨫣靗 蚌▅龜噴ノ笆𨧤
ネм籔洛媚玻穨笆篈(尿)
︽綪𨫋𨫣
垂𤪤籔らセ閩狥て廄𨫋𨫣耎𡛺浪噴剛警カ初𡡀らセ𣽿跋
ぱ耐ネて寕м倈い𦹲媚к癌借波肞玻珇㶏䣝瓣叐カ靗パ䣝瓣胺眃厦珇そ𣊭𩂈瞶綪扳
い繼ネм𨰻眔𡛺嘲洤㻞𤇍𨗴弘燦て𡡡そ𣊭ぇ適膀璮ヌ觟荒倈瓣悔カ初𩂈瞶
獺狥腂𢚘籔䣝瓣䮎𡛺硄隔壩帽璹𤎌𡡡瞈睪綪扳𨫋𡲥
ㄢ─𤤯媚穨倈𨫋𨫣薄䛵
Thank You !
