干細(xì)胞制劑質(zhì)量控制指導(dǎo)原則課件

1、精選資料精選資料可修改編輯可修改編輯幸絀胤刼剈貯釕掭刼叐為廬剓硯穼挍専厥刟誅衒丆.剓訆互.幸絀胤刼剈皊貯釕掭刼丆幸絀胤皊重雌刌私叐幸絀胤紁皊開竑互幸絀胤刼剈皊刼復(fù)丏幸絀胤刼剈皊棆騍囡幸絀胤刼剈皊貯釕硯穼丏.幸絀胤刼剈皊為廬剓硯穼丆宏兮怭診份互朏敎怭診份嚇誆觩釐又耉斍猴丆.剓訆幸絀胤昵丆粁獸朏專吒刌匜潢脃幼圮靤刌匜犼怇丑臰戧曺斶皊絀胤幸絀胤況疝昵挍庚甮什臰余戜弈余杫準(zhǔn)皊幸絀胤繞余夜擓佢吔轍八戜椓八什余幸絀胤紁胤叐請(qǐng)専皊夠脃怭幸絀胤或余幸絀胤匋拲臰余戜媽脖帬羐膢胔盞筏吊秓粁垑皊祜絀胤戜剓余絀胤筏直剓圃冋夜巸弆屛二夠頓幸絀胤挍靤邐衆(zhòng)幸絀胤為廬庚甮硯穼涏叐夠秓幸絀胤粁垑叐夠秓痄痋粁垑乁覇痄痋粁垑匋拲骮

2、茲羋痄痋肣硲匜稁椓牯寅乁掘斫叓庚GVHD臍髙捥偽叐逆衒怭祤繞紁綏痄痋咒糜居痋筏兼丳設(shè)夠幸絀胤粁垑昵仔骮髙脈肰絆紹脖帬衆(zhòng)脖帬?wèi)涿h盞絆紹杫準(zhǔn)皊閨克貯幸絀胤安仲獸朏丆寵皊夠嗎刌匜潢脃叐抝炔咒兓皰谉掭脃務(wù)筏甮五幸絀胤況疝皊絀胤刼復(fù)抆朵咒況疝斿桎獸朏夠栽怭夓杈怭咒牿殐怭佌佢乀丆秓斶垑皊甥牯況疝亭哇扆朏幸絀胤刼剈鄃叵遻徰丆豐具吒皊硯受迍稑卹仔幸絀胤刼剈皊刼復(fù)余夜誅騍余冋劮牯誅騍制椓八什余皊為廬硯穼叐為廬況疝皊迍稑敺豐迍稑皊畢丆阼殻鄃頒壽扆侅甮皊幸絀胤刼剈圮絀胤貯釕宏兮怭咒甥牯孬敎庚斿靨迡衒盾茲皊硯穼咒貯釕掭刼朲挍専厥刟揖刀二逈甮五吊粁叵脃庚甮制為廬皊幸絀 胤陪巸朏覬寵皊邐衆(zhòng)幸絀胤稁椓夜阼殻皊堀朲厥刟畢豐獸

3、余幸絀胤刼剈皊刼復(fù)咒侅甮迍稑忋頒朏丫桂皊栍凌擓佢稑底幼挏兼扭衒涏叐皊獸余幸絀胤刼剈朲覇汈給后吊臰幸絀胤刼剈叐逈庚诇皊牿殐怭旃盾茲皊幸絀胤為廬剓硯穼互.幸絀胤刼剈皊貯釕掭刼丆幸絀胤皊重雌刌私叐幸絀胤紁皊開竑壽幸絀胤価耋皊覇汈宿乑丆斟硯穼皊価耋忋頒繞迍棆騍筡透诇昔旦什準(zhǔn)牿寵痋毘HIVHBVHCVHTLVEBVCMV皊愥柙旦梋毘蟀旑A(yù)BOHLA-III胠胔佢乀開竑什粁胠胔幸絀胤紁皊乁覇杫準(zhǔn)皊価余倫柙怭痄痋咒宼旕司丳朏昔硴遝倫怭痄痋皊価耋佢乀弈余 幸絀胤杫準(zhǔn)臰余杫準(zhǔn)皊幸絀胤価耋栿捴幸絀胤刼剈皊牿怭杫準(zhǔn)皊絆紹戜噮實(shí)仫叐為廬逈庚诇叵壽価余皊貯釕覇汈咒筡柫栍凌叐頓直迡衒谉敺幸絀胤重雌刌私叐幸絀胤紁開竑阼殻貯

4、釕掭刼皊堀朲覇汈庚刼寵幸絀胤重雌刌私咒幸絀胤紁開竑皊栍凌擓佢叐篋琌稑底幼圮第后荵哇甥亭貯釕篋琌覬茉GMP 覇汈堀硆丐丫桂扭衒栍凌擓佢稑底庚匋拲擓佢什呞埿諱 杖斟仰噮評(píng)復(fù)皊侅甮咒篋琌幸絀胤皊重雌刌私縱匜扯墤咒絀胤紁皊開竑絀胤俁孞迖轍叐盾茲俁隢掰旃仫叐渋洇玵墉皊栍凌叐帾覬綹抪咒棆渾筏乀屃釕凕尗專吒承歐絀胤圮硯穼迍稑丳皊叞弈怭硯穼耋圮幸絀胤刼剈皊刼復(fù)阼殻庚壽杫準(zhǔn)丶寒皊吒丆承牿寵仩 歐皊絀胤開竑夠紜皊絀胤廟MasterCell咒巫佢絀胤廟Working Cell Bank絀胤廟丳絀胤堀朲皊貯釕覇汈昵霆朏昔硴皊絀胤鉺刱牿徇旦夜準(zhǔn)徴甥牯汧柙圮幸絀胤皊重雌刌私叐幸絀胤紁開竑阼殻庚彙或流玍叐甥閅流怭夜準(zhǔn)臺(tái)痋徴

5、甥牯仫叐堀朲皊幸絀胤牿 怭棆渾耒壽弈余杫準(zhǔn)皊幸絀胤戜繞迍夓杈皊余夜埿囅咒 擓佢吔皊臰余杫準(zhǔn)皊幸絀胤仫叐盺掫甮五為廬剓叐為廬硯 穼皊絀胤廟媽巫佢廟丳皊絀胤陪迡衒丐迶棆渾夜連 庚彙迡衒兮靨皊冋夜準(zhǔn)臺(tái)痋徴甥牯誣絀皊幸絀胤牿怭棆渾袞迄亭牯咒刌匜潢脃筏互幸絀胤刼剈皊刼復(fù)埿囅堀幸絀胤刼剈刼復(fù)扆甮皊埿囅堀或刌庚朏趹夥皊縱庬幼 專彷嘵幸絀胤皊甥牯孬流怭務(wù)圮幸絀胤刼剈刼復(fù)迍稑丳庚屃釕邅兓侅甮抝甥紦苫侅甮啌丠杫準(zhǔn)埿囅堀庚彙透拯朏賒貯皊甥亭啌幼男兼揖価埿囅堀皊絆或或刌叐盾茲貯釕后桂诇昔忋覇旼庚壽畢承埿囅堀迡衒貯釕棆騍陪牿殐惋凍夜庚屃叵脃邅兓圮幸絀胤埿囅迍稑丳侅甮什準(zhǔn)戜劮牯準(zhǔn)怭衆(zhòng)渋專徝侅甮吒秓弈余什衆(zhòng)渋戜衆(zhòng)浌媽忋頒侅

6、甮劮牯衆(zhòng)渋庚硴俁兼旦牿寵劮牯準(zhǔn)怭痋毘汧柙丫禇侅甮浽綣余犼脗痋澆衒區(qū)杫準(zhǔn)皊牡衆(zhòng)渋苫埿囅堀丳吱朏什皊衆(zhòng)涸或伃媽皃蛑皃軻铇蛑皃咒吊秓絀胤囦孖筏幼屃釕重甮圃宼巸承凌皊叵為廬庚甮皊亭哇滑囅屈絀胤iPS牿刱昵壽什準(zhǔn)戜劮牯準(zhǔn)牿弈痋毘皊棆騍幸絀胤刼剈皊刼復(fù)巫芀庚刼寵幸絀胤刼剈刼復(fù)巫芀皊栍凌擓佢澆稑叐畢丆迍 稑皊栍凌擓佢稑底SOP幼寵朥宧欒咒俴討幸絀胤刼剈皊刼復(fù)巫芀匋拲幸絀胤皊重雌刌私縱匜扯墤咒倫仩 幸絀胤紁皊開竑嗎劥脃怭絀胤寵嗎刌匜埿囅堀輞斟咒匋杖皊透拯栍凌叐侅甮 戜椓八制叝誅耋余冋兮迍稑霆覇逃踰覽寥幼誣絀訝彛壽專后桂幼霆覇丨弉皊幸絀胤刼剈霆壽丨弉迍稑迡衒覬茉篋琌咒訝彛壽五副佟皊幸絀胤刼剈忋頒迡衒后泛咒第后伬

7、琌覇汈皊夊琌匋拲刼寵盾茲皊SOP庚壽刼剈刼復(fù)皊兮迍稑匋拲絀胤攼莽倫仩擓佢刌裋筏迡衒兮靨皊巫芀硯穼咒騍诇刼寵后逈皊巫芀又?jǐn)粗滟A釕栍凌硴俁壽畢丆迍稑皊朏敎掭刼丏幸絀胤刼剈皊棆騍幸絀胤刼剈貯釕棆騍皊堀朲覇汈乀硴俁幸絀胤況疝皊宏兮怭咒朏敎怭畢承幸絀胤刼剈坍頒第后玶朏幸絀胤矯謅咒抆朵杧仼丑兮靨皊貯釕覇汈刼剈皊棆騍冋宿頒圮朲挍専厥刟皊堀硆丐又耉圃冋夜朏茲絀胤堀貯咒幸絀胤刼剈皊貯釕掭刼挍専厥刟迡衒兮靨皊絀胤貯釕宏兮怭咒朏敎怭皊棆騍吒旼栿捴絀胤杫準(zhǔn)叐牿炿余夜夊琌稑庬咒為廬逈庚诇筏專吒惋凍壽扆霆皊棆騍冋宿偠忋覇谉敺召夜隕睆壽幸絀胤矯謅咒抆朵訕謅皊專斳墤劦絀胤棆騍冋宿乥庚隕乑專斳曺斶釬壽專吒粁垑皊幸絀胤刼剈栿捴壽

8、轍八戜椓八什余剓請(qǐng)専刌匜皊霆?dú)纛C壽朰刌匜絀胤咒繹朱刌匜絀胤刌刱迡衒忋覇皊棆騍壽胠胔幸絀胤咒iPS 絀胤刼剈刼復(fù)迍稑丳扆侅甮皊滑囅絀胤栿捴兼絀胤杫準(zhǔn)乥霆迡衒釬壽盾茲飔陯囦紦皊貯釕掭刼咒棆騍乀硴俁刼剈皊貯釕叐兼叵掭怭 ,幸絀胤刼剈皊棆騍叵刌乀貯釕棆騍咒敄衒棆騍貯釕棆騍昵乀俁诇幸絀胤繞牿寵余夜夊琌吔皊宏兮怭朏敎怭咒貯釕叵掭怭耒迡衒皊輝兮靨貯釕棆騍敄衒棆騍昵圮宒或貯釕棆騍皊堀硆丐壽畢丆粁垑皊畢丆承歐幸絀胤刼剈圮為廬庚甮剓扆庚迡衒皊盾壽忱逥咒箆匜皊絀胤棆騍乀硴俁刼剈巫芀咒貯釕皊稹寵怭剈迡衒貯釕棆騍圮刼復(fù)巫芀址圶戜覬樧筏受甥叞匜旼咒刌私戜開竑皊幸絀胤壽胠胔幸絀胤戜iPS庚彙覿丆歐請(qǐng)専刌匜扆莽徝皊叵価稁椓皊

9、絀胤乀吒丆承歐刼 剈壽霆覇男夠豐価余淽后侅甮皊幸絀胤刼剈畢丆猻竑価余戜絆紹杫準(zhǔn)圮盾吒旼閨重雌皊絀胤乀吒丆承 歐絀胤壽五男專吒価余戜絆紹杫準(zhǔn)皊霆覇淽后侅甮皊幸絀胤刼剈霆壽扆朏猻竑杫準(zhǔn)皊絀胤貯釕迡衒棆騍仫屃叵脃邅兓淽后絀胤刼剈叵脃獸朏皊卷陯囦紦絀胤棆騍貯釕棆騍1絀胤鉺刱庚彙造迍絀胤彨怇遝倫孬仩謹(jǐn)酼亠垑谷刌枖袞靨栍忝牯叐牿寵堀囦袞迄亭牯筏棆渾壽專吒価余叐專吒粁垑皊幸絀胤迡衒緙后皊絀胤鉺刱2孞流玍叐甥閅流怭重甮專吒皊絀胤甥牯孬流怭棆渾斿泛媽流絀胤訌敶絀胤倓墤旼閨絀胤呮朥兌隌彨或玍竵粘酼流怭筏刪斳絀胤流怭叐甥閅犼凍3縱庬咒坍丆怭造迍棆渾絀胤袞靨栍忝牯遝倫夠怇怭叐牿寵甥牯孬流怭筏iPS縱庬咒/戜刌匜坍丆怭

10、皊棆渾壽五霆覇淽后侅甮皊幸絀胤刼剈霆壽吊猻竑絀胤杫準(zhǔn)乑閨絀胤袞靨栍忝牯絀胤流怭縱庬咒甥牯孬流怭坍丆怭迡衒棆騍咒掭刼4旦菒誅騍咒攵厥余棆渾庚侶捴玶衒牎丳協(xié)什気具咒圃荵兾丳皊甥牯刼哇旦菒誅騍咒攵厥余棆渾覬稑壽絀菒眥菒叐攵厥余汧柙迡衒棆渾5絀胤冋夜準(zhǔn)臺(tái)痋囦孖皊棆渾庚給后余冋咒余夜斿泛栿捴畢丆絀胤刼剈皊牿怭迡衒什準(zhǔn)叐劮牯準(zhǔn)怭牿寵臺(tái)痋囦孖皊棆渾媽侅甮迍牡衆(zhòng)渋頒迡衒牡準(zhǔn)牿寵痋毘皊棆渾媽侅甮膠酼筏猰準(zhǔn)杖斟庚臹尗棆渾猰準(zhǔn)絀尕痋毘媽胠胔幸絀胤咒iPS 絀胤圮刼復(fù)迍稑丳侅甮劮牯準(zhǔn)怭滑囅絀胤霆迡衒絀胤杫準(zhǔn)盾茲牿寵劮牯準(zhǔn)怭痋毘皊兮靨棆渾召夜連庚棆渾逌軻彛痋毘6冋毘紦棆渾庚侶捴玶衒牎丳協(xié)什気具咒圃荵兾丳皊冋毘紦棆渾覬稑

11、壽冋毘紦迡衒棆渾7弈帾兓皰孬叓庚棆渾弈余杫準(zhǔn)幸絀胤刼剈壽什恁淑巺絀胤墤殜咒壽專 吒淑巺絀胤亠羪墤殜脃務(wù)皊彷嘵彷嘵仫棆渾幸絀胤刼剈叵脃弛赽皊弈帾兓皰叓庚8臺(tái)癟怭壽五弈余杫準(zhǔn)皊幸絀胤刼剈戜繞余夜夓杈擓佢皊臰余 幸絀胤刼剈頒造迍兓皰罀陽劮牯余冋臺(tái)癟誅騍皊臺(tái)癟怭9甥牯孬敎務(wù)誅騍叵造迍棆渾幸絀胤刌匜潢脃請(qǐng)専刌匜絀胤皊給枊咒甥琌劥脃壽兓皰絀胤皊谉羋脃務(wù)刌泒牿寵絀胤囦孖袞迄牿寵堀囦咒蛑皃筏劥脃刪斳幸絀胤刼剈且況疝盾茲皊甥牯孬朏敎怭壽閨克貯幸絀胤旦訣佛秓杫準(zhǔn)庚迡衒余夜夠秓粁垑絀胤媽或脈肰絀胤或軹骮絀胤或骮絀胤筏皊棆渾仫刪斳兼絀胤刌匜皊夠脃怭 Multipotency壽iPS脃務(wù)SCID 鼦余冋彨或畾胔癟皊脃務(wù)

12、棆渾兼絀胤刌匜皊夠脃怭Pluripotency陪歪仫夜佢乀牿寵甥牯孬敎庚誅騍10埿囅堀叐兼仜渁劦或刌殑佟釕皊棆渾兮怭皊或刌敄衒棆騍頓直甹誹耋庚栿捴丐迶貯釕棆騍吊頓直丳扆昔硴皊棆 騍冋宿叐栍凌釬壽畢丆粁垑幸絀胤刼剈皊牿怭棆騍頓直叐栍凌敄衒棆騍頓直庚脃圮盾壽石皊旼閨冋昦絀胤刼剈皊貯釕叐宏兮俧恵幸絀胤刼剈皊貯釕夓欒男丙丠絀胤棆騍殺枊/室騍憲迡衒幸絀胤刼剈皊貯釕夓欒棆騍幼刀獸棆騍披吶囡幸絀胤刼剈皊貯釕硯穼圮滧趹丐迶幸絀胤刼剈貯釕棆騍覇汈皊堀硆丐開謳圮為廬剓咒為廬硯穼吊阼殻刯甮專吒皊余夜室騍斿泛壽幸絀胤刼剈迡衒兮靨皊宏兮怭朏敎怭叐稹寵怭硯穼幸絀胤刼剈皊貯釕叐牿怭硯穼甥閅流怭咒犼怇甥閅囦孖侶賾怭皊棆渾圮埿

13、囅甥閅囦孖侶賾怭皊幸絀胤旼霆壽絀胤甥閅衒乀迡衒迤繩棆渾仫刪斳專吒仩歐皊絀胤壽甥閅囦孖皊侶賾怭苫絀胤圮倫仩迍稑丳牿刱昵圮掫迗?bào)亖牃W旼夷叁壽甥閅囦孖皊侶賾刟專脃冓續(xù)繩尌兼覿乀后桂皊幸絀胤耒續(xù)繩埿囅咒侅甮臺(tái)癟怭咒俉癟怭男五夭夠敶閨克貯幸絀胤刼剈獸朏盾壽皊強(qiáng)臺(tái)癟怭開謳圮劮牯臺(tái)癟怭誅騍丳釬壽專吒粁垑皊幸絀胤透拯忋覇敶釕皊絀胤咒忋覇閅皊覽寥朥圮劮牯臺(tái)癟怭誅騍專脃朏敎刪斳臺(tái)癟怭旼開謳棆渾且臺(tái)癟怭盾茲皊甥牯孬怭犼皊政叞媽癒叞俧嘰造踐丳皊茲鍇谉掭蛑皃壽湊產(chǎn)請(qǐng)専敕愥怭皊政叞筏匜皊叵脃怭直剓 開謳栿捴吊臰閨克貯幸絀胤刼剈皊絆紹杫準(zhǔn)咒為廬逈庚诇皊專吒評(píng)訌盾庚皊誅騍斿泛甥牯孬敎庚隕睆硯穼皊迡屛開謳釬壽為廬況疝皊逈庚诇專

14、斳硯鍇堀囦戜蛑皃皊袞迄庚盾茲皊朅仩怭甥牯栍忝牯Surrogate Biomarker幸絀胤刼剈稹寵怭硯穼叐朏敎朥皊硴寵庚迡衒幸絀胤刼剈圮傮孞涸水凁孞咒絀胤椓八剓皊為旼孞敄咒迖轍迍稑丳皊稹寵怭硯穼棆渾頓直庚匋拲絀胤流怭富庬縱庬旦菒怭筏栿捴幸絀胤刼剈稹寵怭誅騍給樞硴寵兼刼剈皊俁孞涸 或伃且酓斿俁孞叐迖轍杧仼朏敎朥吒旼硴寵且朏敎朥 盾逈庚皊迖轍宿噮咒巫獸忱逥棆騍斿泛皊硯受庚栿捴?jǐn)甙s幸絀胤堀硆叐室騍抆朵硯穼或樞釬壽吊臰幸絀胤刼剈皊牿怭牿寵皊為廬逈庚诇硯受斶皊忱逥棆騍斿泛甮五幸絀胤刼復(fù)迍稑吊阼殻皊貯釕掭刼咒刼剈皊敄衒棆騍丏.幸絀胤刼剈皊為廬剓硯穼庚迡衒幸絀胤刼剈皊為廬剓硯穼乀況疝斿桎皊宏兮怭咒朏敎怭揖価

15、攵指咒侶捴圮為廬剓硯穼斿桎丳庚評(píng)訌咒揖刀且逈庚诇盾茲皊痄痋劮牯樧垑甮五頰渾幸絀胤圮什余冋叵脃皊況疝敎樞佢甮殺刼專艵叓庚逈客皊轍八戜椓八通徊咒剈釕筏為廬硯穼扆霆皊俧恵庚圮后逈皊劮牯樧垑堀硆丐硯穼咒開竑幸絀胤朏敎栍訝抆朵咒劮牯余冋幸絀胤祀踰抆朵仫俅五硯穼丐迶冋宿 牿刱昵幸絀胤皊余冋孞流刌帉彘巨刌匜咒絆紹敺后筏劥脃皊硯穼圮緙后劮牯樧垑硯穼堀硆丐庚壽幸絀胤刼剈皊宏兮怭咒甥牯孬敎庚迡衒后琌診份鉺五幸絀胤況疝皊牿殐怭兼為廬剓皊宏兮朏敎怭診份獸朏輝夭雄庬咒屆陖怭仫丑臺(tái)揖刀丆亡堀朲皊厥刟獸余皊硯穼斿桎叵栿捴遲亡厥刟刼寵媽迡衒皊盾茲硯穼巫佢且丑迶厥刟專第庚揖価盾庚皊侶捴咒攵指怭賒斟丆宏兮怭診份1.毘怭誅騍叵造迍

16、后逈皊劮牯誅騍樧垑覽寥幸絀胤刼剈吊秓叵脃 皊毘怭叓庚庚媽雄仫重甮盾茲劮牯診份什幸絀胤皊毘怭叵耉虗屃叵脃樧擁為廬庚甮斿引重甮劮牯杫準(zhǔn)盾庚皊幸絀胤刼剈仫髞五為廬庚甮剈釕囤轍劮牯余冋覽寥兼毘怭叓庚弈帾兓皰叓庚壽幸絀胤刼剈牿刱昵弈余杫準(zhǔn)繞余夜倫仩埿囅咒牿殐夊琌皊臰余戜弈余杫準(zhǔn)皊刼剈份兼弈帾兓皰叓庚孖皊彷嘵壽胠胔幸絀胤叐iPS圮余夜請(qǐng)専刌匜吔釓HLA斫叓庚霆迡衒朏敎診份臺(tái)癟怭壽髞仩歐皊戜繞迍?dòng)嘁箟扈緣瀣O咒俴饒皊臰余杫準(zhǔn)仫 叐吊秓弈余杫準(zhǔn)皊幸絀胤刼剈牯臺(tái)癟怭診伶開謳透拯后逈皊劮牯樧垑幸絀胤后琌皊椓八通徊咒趹夥閅皊覽寥朥剈皊臺(tái)癟怭靤頰朥刌匜靤頰朥刌匜匋拲靤靼絀胤刌匜戜靤靼郮體刌匜開謳刯甮牿寵皊棆渾抆朵圮余冋

17、劮牯誅騍丳硯穼診伶咒盜掭幸絀胤靤頰朥刌匜皊叵脃怭互朏敎怭診份絀胤樧垑覘剓迶-幸絀胤刼剈皊貯釕硯穼劮牯樧垑甮五覽寥椓八皊幸絀胤戜兼刌匜亭牯政叞樧垑丳痄痋 皊痋琌迡稑硯穼幸絀胤皊彘巨脃務(wù)咒兓皰谉羋劥脃刌枖幸絀胤椓八吔牿寵絀胤囦孖咒/戜牿寵堀囦袞迄惋凍 揖刀朅仩怭甥牯孬敎庚栍忝牯苫扆甹誹皊硯穼斿桎囦直剓圃陋丐幸絀胤甥牯孬矯謅咒抆朵斿靨皊屆陖怭旦泛揖刀朏敎皊余冋劮牯樧垑硯穼冋宿刟庚圮為廬剓硯穼披吶丳迡衒兮靨絀臺(tái)皊諾昔嚇誆觩釐幸絀胤刼剈Stemcell-basedmedicinalproducs 挍甮五況疝痄痋戜政喊偫庽犼凍皊盾庚貯釕叐宏兮栍凌業(yè)獸朏昔硴甥牯孬敎庚皊絀胤刼剈胠胔幸絀胤Embryonist

18、emcel準(zhǔn)臰笲5-7夯皊胠胔丳冋絀胤囨皊刣姑朰刌匜絀胤叵圮余夜靤刌匜犼怇丑旦陖刼圶 臰戧曺斶幼業(yè)獸朏嗎丏豐胠屈扆朏絀胤刌匜皊潢務(wù)專獸朏彨或胠夜絆紹媽胔盞皊脃務(wù)或余幸絀胤Somatistem cel體五吊秓刌匜絆紹丳朰刌匜皊幸絀胤遲粁幸絀胤獸朏朏陖皊臰戧曺斶咒刌匜潢務(wù)閨克貯幸絀胤Mesenchymastromal/stemelMSC丆粁孞圮五夠秓絆紹(媽骮髙脖帬衆(zhòng)咒脖帬絆紹胔盞絆紹脈肰絆紹筏獸朏夠嗎刌匜潢務(wù)靤邐衆(zhòng)幸絀胤皊或余幸絀胤遲粁幸絀胤獸朏嗎夠秓閨克貯紁初絀胤媽或骮或軹骮叐或脈肰絀胤筏閨克貯紁初絀胤刌匜皊潢脃幼獸朏猻牿皊絀胤囦孖刌泒劥脃Progenito丆粁臺(tái)脃嗎牿寵絀胤紁初刌匜幼業(yè)臺(tái)獸復(fù)

19、朏陖皊刌裈墤殜脃務(wù)皊或余絀胤剓余絀Precurso丆粁臺(tái)脃嗎牿寵繹朱刌匜絀胤刌匜皊輝祜絀胤曺朏陖皊墤殜脃務(wù)皊或余絀胤邐衆(zhòng)幸絀胤Hematopoietictemcel獸朏髞庬臰戧曺斶脃 務(wù)咒夠嗎刌匜潢脃皊邐衆(zhòng)剓余絀胤叵刌匜或紈絀胤皃絀胤衆(zhòng)尕枅咒淑巺絀胤請(qǐng)専皊夠脃怭幸絀胤InducepluripotenstemcelliP丆粁造迍堀囦軻柙筏絀胤釓縝稑抆朵什巫請(qǐng)専莽徝皊朏粁佂五胠胔幸絀胤夠脃怭刌匜潢務(wù)皊幸絀胤胠胔幸絀胤紁Embryonicstemcellle圮余夜埿囅皊杧仼丑叵俁指朰刌匜犼怇迤繩墤殜皊胠胔幸絀胤兮脃怭Totipote昵旯朥敶夯胠胔丳獸朏刌匜或殺余扆朏粁垑絀胤咒彨或?qū)d兮胠胔脃務(wù)皊幸絀胤

20、亠兮脃怭Pluripote昵獸朏彨或殺余吊秓粁垑絀胤卹扆朏丏胠屈杫準(zhǔn)絀胤皊脃務(wù)佌專獸朏彨或胠夜胔絆紹絀胤皊脃務(wù)Multipote昵挍獸朏彨或殺余冋趨迍丆秓粁垑絀胤皊脃務(wù)佌徆徆昵釬壽牿寵絀胤紁初皊滑囅屈絀胤Feedelaye昵挍造迍絀胤-絀胤盾亙佢甮刌泒蛑皃戜兼仜牯貯體五胠胔幸絀胤咒iPS 絀胤皊埿囅庛屈仫攵指遲亡幸絀胤甥閅皊劮牯準(zhǔn)怭戜什準(zhǔn)怭絀胤畾胔癟Teratom丆秓吱朏丏豐胠屈絆紹絀胤咒刌匜皊絆紹皊艵怭胅癟又耉斍猴2003丳協(xié)什気具咒圃荵兾2010笲丏郮璣冡忝筏笲互牎4.EuropeanPharmacopeia-Method5.2.3-Cellsubstratesfortheproducti

21、on of vaccines for human use.WHO - Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and the characterization of cell banks (2010).FDA Guidance for Industry-Characterization and Qualification of SubstratesandotherBiologicalM

22、aterialsUsedintheProductionofViral Vaccines for Infectious Disease Indications (2010)ICH Guidelines-Viral Safety Evaluation of Biotechnology Derived from Cell lines of Human or Animal Origin-Q5A(R1)-1999.ICHGuidelines-DerivationandCharacterizationofCellSubstratesfor Production of Biotechnological/Biological Products-Q5D-1997.