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Ukuze Ube Umholi Wemboni ye-Bio-enzyme API yaseChina

E-GUANGHAN, ECHINA / ACCESSWIRE / Agasti 20, 2021 / Ngomhla zingama-27 kuMbasa, u-Zhang Ge, uSihlalo weBhodi kanye noMongameli we-Sichuan Deebio Pharmaceutical Co., Ltd. (okuzobizwa kamuva ngokuthi i-Deebio), wabamba iqhaza ku-China Bio-enzyme High-quality Development Isemina.Uthe emhlanganweni, “Ngemuva kweminyaka engu-27 yentuthuko, sithuthuke sisuka endaweni encane yokucobelelana ngolwazi saba inkampani esezingeni elejwayelekile yokuthaka imithi ye-API.Namuhla, i-Deebio iyinkampani ehamba phambili emhlabeni yokukhiqiza i-bio-enzyme kanye nenkampani yochwepheshe be-R&D. "

U-Zhang Ge wayezethemba ngalokho ayekushilo.Idatha ibonisa ukuthi i-Deebio ineziqu namandla okukhiqiza izinhlobo ezingaphezu kweziyi-10 ze-Bio-enzyme API, phakathi kwayo i-kallidinogenase ngokuyisisekelo ithatha imakethe yomhlaba wonke;amasheya emakethe e-pancreatin, i-pepsin, i-trypsin-chymotrypsin neminye imikhiqizo yonke idlula ama-30%;emakethe yomhlaba, i-Deebio ukuphela kwe-API umphakeli we-elastase, i-pepsin yesisombululo esicacile ne-pancreatin enomsebenzi ophezulu we-lipase e-China.Kusukela ngo-2005, i-Deebio ithole isitifiketi se-CN-GMP ne-EU-GMP, nemikhiqizo yayo ithunyelwa emazweni angama-30 emhlabeni jikelele, okuhlanganisa i-Europe, i-America, i-Japan kanye neNingizimu Korea iminyaka engaphezu kwe-20.Inguzakwethu wesikhathi eside we-Sanofi, Celltrion, Nichi-Iko, Livzon nezinye izinkampani zemithi ezivelele.

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"Lezi zinzuzo zihlomula kakhulu ekusungulweni kwezobuchwepheshe, ukuphathwa okujwayelekile kanye nokukhiqizwa okuluhlaza."U-Zhang Ge uthe, “Ngenxa yemizamo engapheli ka-Deebio yekhwalithi ephezulu, imikhiqizo ye-bio-enzyme API inezinzuzo ezifana nokusebenza okuphezulu, ukuhlanzeka okuphezulu nokuzinza okuphezulu futhi ngenxa yalokho yamukelwa kabanzi ngabalingani.

Ukwenza Okungcono Kakhulu

Ama-bio-enzyme angamaprotheni anemisebenzi ye-catalytic, ehlukile kwamanye amaprotheni ngoba anesikhungo esisebenzayo.I-API ye-bio-enzymes itholakala ngokuhlukaniswa, ukukhishwa nokuhlanzwa kwezinto eziphilayo.

“I-Bio-enzyme API iyimboni etshalwa imali enkulu, inzuzo ephansi kanye nengozi enkulu yezobuchwepheshe.Izinga lemboni lincane.Futhi zimbalwa izinkampani ezibambe iqhaza kuyo. ”NgokukaZhang Ge, ubungozi obukhulu bezobuchwepheshe bubangelwa umsebenzi wama-enzyme okwenza inqubo yokuhlanza ibe nzima kakhulu.Isibonelo, uma inqubo ingalawulwa kahle, umkhiqizo ungase ungabi nawo umsebenzi, bese ulahlekelwa inani lawo lokwelapha.

I-Bio-enzyme API ingenye yezinto ezingavuthiwe ze-bio-pharmaceuticals.Ngobuthi obuphansi kanye nemiphumela emibi, i-bio-pharmaceuticals ihloselwe kakhulu ukwelashwa kwezifo ezithile futhi imuncwa kalula ngumzimba womuntu.Inemiphumela ehlukile yokwelapha yesifo sikashukela, izifo zenhliziyo, izimila kanye nezifo ezibangelwa amagciwane.

“Ifilosofi yami engaguquki iwukuthi inqobo nje uma ngenza lokho abanye abangakwenzi, ngikwenza okungcono kakhulu.”UZhang Ge ukholelwa ukuthi isizathu sokuba agxile embonini ye-bio-enzyme iminyaka engaphezu kwengu-20 uthando lwakhe olusuka enhliziyweni ngama-enzyme.Ngo-1990, ngemva kokuphothula eNyuvesi yaseSichuan (EyayiyiNyuvesi Yangaphambili yase-Chengdu Yesayensi Nobuchwepheshe) egxile kwi-biochemistry, u-Zhang Ge wasebenza njengochwepheshe futhi kamuva waba ngumqondisi welabhorethri e-Deyang Biochemical Pharmaceutical Factory.Eminyakeni emihlanu kamuva, ngenxa yokulungiswa kabusha kwefekthri, wathatha ibhizinisi.

“Ngaleso sikhathi, imboni yamakhemikhali ezinto eziphilayo yayisizoguqulwa ibe inkampani eyenza imithi.Ngaya efektri ngiyobheka futhi ngabona ukuthi intsha embalwa yayilungisa kabusha ishabhu elincane elidala.Ubuso babo babugcwele amanzi nodaka.Phakathi kwabo bekukhona noZhang Ge.”UZhong Guangde, owayeyiPhini Lomqondisi Wehhovisi Lokuphathwa Kwezokwelapha Kwesifundazwe saseSichuan, ukhumbula ngomzwelo, “UZhang Ge useyileya nsizwa eyenza izinto ezingokoqobo emehlweni ami.”

NgoDisemba 1994, uZhang Ge wasungula iSichuan Deyang Biochemical Products Co., Ltd. Ngokushesha nje lapho isungulwa, yacishe yashabalala.

“Ekuqaleni kwawo-1990, ukuqwashisa ngekhwalithi kwemboni yaseChina ye-Bio-enzyme ngokuvamile kwakungenamandla, futhi ukuqonda kwethu ama-enzyme kwakusenomkhawulo ekwazini ukuthi umsebenzi omuhle wama-enzyme wanele.”Ngokuka-Zhang Ge, ngoMashi 1995, i-Deyang Biochemical Products Co., Ltd. eyayisanda kusungulwa yathola i-oda layo lokuqala le-kallidinogenase engahluziwe ukuze ithunyelwe emakethe yaseJapane.Kodwa-ke, imikhiqizo yanqatshwa ngenxa yokuhluka kwama-milligrams ambalwa kokuqukethwe kwamafutha.“Uma elinye iqembu licela isinxephezelo, inkampani yayizowa, futhi imali yesinxephezelo yayilingana nezinkanyezi ngaleso sikhathi.Ngenhlanhla, ngokusebenzisana, elinye iqembu alizange lisicele ukuthi sihlawule kodwa asinikeze kabusha imikhiqizo, ”kusho uZhang Ge.

Lokhu okuhlangenwe nakho kwafundisa uZhang Ge, owayesanda kuqala ibhizinisi, isifundo esibalulekile futhi kwamenza wabona ukuthi izinga lomkhiqizo liwumgogodla wempilo yenkampani.Eminyakeni elandelayo ye-27 yentuthuko, inkampani ibilokhu inamathela ezindinganisweni eziqinile zekhwalithi.Ngokusekelwe eminyakeni yocwaningo oluyisisekelo, i-Deebio iye yathuthukisa njalo ubuchwepheshe bayo, ngaleyo ndlela yenza ukuvikelwa komsebenzi we-enzyme yenqubo egcwele, ukusebenza okungabhubhisi kanye nobuchwepheshe bokuhlanza obunembile ukuze kuqinisekiswe umsebenzi ophezulu, ukuhlanzeka okuphezulu nokuzinza okuphezulu kwemikhiqizo ye-Bio-enzyme API.

Ukungawugodli Umzamo Wokutshala Kwezinto Ezintsha

“Imboni ye-bio-enzyme API ibonakala ngamanani amancane nokuhlukahluka.Ngaphandle kokusungula izinto ezintsha zobuchwepheshe, umkhiqizo owodwa noma emibili ayikwazi ukusekela inkampani ukuthi ithuthuke.I-Deebio inomkhiqizo owodwa kuphela kusukela yasungulwa.Kodwa namuhla kunama-API e-bio-enzyme angaphezu kweshumi nambili, angenakuhlukaniswa nokutshalwa kwezimali kwethu okuqhubekayo kwezobuchwepheshe. "Kusho uZhang Ge.

I-Trypsin-Chymotrypsin iyi-enzyme ye-proteolytic ehlukaniswe futhi yahlanzwa kumanyikwe wengulube.Ingenye yemikhiqizo eyinhloko ka-Deebio.I-R&D yalo mkhiqizo izuze ekubambisaneni kocwaningo lwemboni-inyuvesi.Ngo-1963, u-Qi Zhengwu, umcwaningi e-Shanghai Institute of Physiology and Biochemistry of the Chinese Academy of Sciences, wasebenzisa ukuvuselela kabusha ukuze akhiphe ikristalu exubile ye-chymotrypsin ne-trypsin kumanyikwe wengulube, eyaqanjwa ngokuthi i-trypsin-chymotrypsin.Le enzyme yayingakaze yenziwe izimboni iminyaka engaphezu kwengu-30.UZhang Ge wabona ithuba kukho.“Ngo-1997, sabambisana neqembu locwaningo lesazi semfundo ephakeme u-Qi Zhengwu ukuze siqaphele ukwenziwa kwezimboni kwe-trypsin-chymotrypsin futhi sazuza izinzuzo ezinhle kwezomnotho nezenhlalo.Ngesikhathi esifanele, amathani angaphezu kuka-20 ngonyaka alo mkhiqizo athunyelwa eNdiya.”NgokukaZhang Ge, isazi semfundo ephakeme u-Qi Zhengwu sithe “Ngokumangalisayo, imikhiqizo yami yenziwe ngamabhizinisi asemalokishini nawedolobhana.

Ngemva kokunambitha ubumnandi bokuqanjwa kabusha kwezobuchwepheshe, u-Deebio uye wandisa utshalomali lwakhe kwezobuchwepheshe, futhi wathuthukisa ukubambisana okuseduze kocwaningo lwemboni-inyuvesi-inyuvesi ne-Tsinghua University, i-Chinese Academy of Sciences, i-Sichuan University, i-China Pharmaceutical University nezinye izikhungo zemfundo ephakeme kanye nezikhungo zocwaningo. , ukwakha ngokuhlanganyela amalabhorethri, ngokuqhubekayo ukuthuthukisa amakhono eqembu ocwaningo lwesayensi nokusungula izinto kanye nokwakha iqembu lokukhiqiza ne-R&D elinamandla okuguqula ubuchwepheshe obuphezulu elithole ngokulandelanayo ubuchwepheshe obunamalungelo obunikazi angu-15.

Ukuze kuthuthukiswe ikhwalithi yomkhiqizo, ngo-2003, u-Deebio wabambisana nozakwethu waseJalimane onekhono elithuthuke kakhulu lobuchwepheshe namandla okuphatha ukuze asungule ibhizinisi elihlangene elibizwa ngokuthi i-Deyang Sinozyme Pharmaceutical Co., Ltd. “Ngalowo nyaka, satshala imali engaphezu kwezigidi ezingu-20 zamayuan. ukwakha isikhungo esisha, esinezinto zokukhiqiza ezakhiwa ngezinto ezisezingeni eliphezulu emhlabeni.Ngesikhathi esifanayo, imboni ingakhiwa eShayina ngamayuan ayizigidi ezi-5.Izindleko zokwakha iSinozyme zilingana nezimboni ezi-4.”NgokukaZhang Ge, uzakwethu waseJalimane uvakashele inkampani ukuze anikeze umhlahlandlela izinsuku eziyishumi njalo ngenyanga.Ngokwethulwa kwezindlela ezithuthukisiwe zokuphatha uhlelo lwekhwalithi, ikhono lokuphatha uhlelo lwekhwalithi yeSinozyme liye lakhushulelwa ezingeni eliphezulu kakhulu lamazwe ngamazwe.

Ngo-2005, iSinozyme yaba inkampani yokuqala yaseShayina ye-pancreatin ukuthola isitifiketi se-EU-GMP;ngo-2011, kwasungulwa iSichuan Deebio Pharmaceutical Co., Ltd.;ngo-2012, u-Deebio wathola isitifiketi se-CN-GMP;ngo-January 2021, i-Deebio (Chengdu) Bio-technology Co., Ltd. yasungulelwa i-R&D, ukukhiqizwa nokusetshenziswa kwezidakamizwa eziqediwe eziphezulu kanye namalungiselelo e-enzyme ye-biotechnology.

“Ngicabanga ukuthi izinkampani kufanele zizimisele ukutshala imali ekusunguleni ubuchwepheshe bokukhiqiza.U-Deebio wakha imboni entsha njalo eminyakeni eyi-7 kuye kweyi-8.Kule minyaka, inzuzo eningi itshalwe ekwakhiweni kwebhizinisi, ukuguqulwa kwemishini yokukhiqiza kanye nokwethulwa kwethalente.Abanamasheya nabaphathi bathola izabelo ezimbalwa.”U-Zhang Ge, owake waba unjiniyela, ukuqonda ngokugcwele ukubaluleka kokutshalwa kwezimali kwezobuchwepheshe.Wagcina ijubane lokuqamba izinto ezintsha, futhi wabala uchungechunge lwezinto okufanele zenziwe: Ishabhu entsha ka-Deebio ye-GMP eyakhiwe ngokuhambisana nezindinganiso ze-FDA yaqalwa ngonyaka odlule futhi kulindeleke ukuthi iqedwe ngasekupheleni kukaMeyi futhi ifake ukukhiqizwa kwesilingo;I-Deebio (Chengdu) Bio-technology Co., Ltd., ese-Wenjiang, e-Chengdu, iqale ukwakhiwa ngokusemthethweni ngo-Ephreli 26 futhi kulindeleke ukuthi iqale ukusetshenziswa ngokusemthethweni ngo-Okthoba.

“Ukukhiqizwa Okuluhlaza Yilokho Engiziqhenya Kakhulu Ngakho”

Ukungcoliswa kwe-API bekulokhu kuwukukhathazeka komphakathi, futhi ukuvikelwa kwemvelo sekuphenduke indawo enengcindezi enquma ukusinda kwamabhizinisi.Ukunamathela ekukhiqizeni okuluhlaza yilokho uZhang Ge aziqhenya ngakho.

“Ngesikhathi siqala ukuthuthukiswa kwenkampani, asizange sinake kakhulu izindaba ezithinta imvelo.Kodwa-ke, njengoba izwe libeka phambili izidingo zokuvikelwa kwemvelo, saqala ukubona ukubaluleka kwakho.”NgokukaZhang Ge, eminyakeni eyishumi edlule, u-Deebio uye wayinaka kakhulu, elwela ukuzuza intuthuko esimeme.

Kube yisigameko esenze ukuthi kube noshintsho.“Emhlanganweni eminyakeni eminingi edlule abaphathi benkampani yethu bebehlela ngomkhiqizo odinga izinto ezisebenza ngamakhemikhali.Esinye seziphehlisi zamakhemikhali asikwazanga ukwehliswa futhi, uma amanzi angcolile ekhishelwe emfuleni, kungase kubangele ukukhubazeka kwezingane.Angizange ngingananazi ukwenqaba lo mkhiqizo.”Ekhuluma ngalesi sigameko, uZhang Ge wayephatheke kabi kakhulu, “Idolobha lakithi liseduze komfula iTuojiang, okuqhele ngamakhilomitha angaphezu kuka-200 ukusuka eGuanghan, eSichuan.Futhi umfula oseduze kwemboni yethu ugelezela eMfuleni iTuojiang.Ukuchithwa kwamanzi alahlwayo okuqondile kuyicala elibhekiswe ezizukulwaneni ezizayo.Ngakho ngeke ngiyenze into enjalo.”

Kusukela lapho, u-Deebio uye wabeka ukuthi inqobo nje uma inqubo yokukhiqiza ihilela izinto zokusetshenziswa zamakhemikhali ezinobuthi neziyingozi noma izinto ezisizayo ezingakwazi ukucutshungulwa ekuthuthukisweni kwemikhiqizo emisha, ukuthuthukiswa ngeke kuvunyelwe, futhi uye waphikelela ekutshaleni imali ekuvikelweni kwemvelo eminyakeni eyishumi.

Namuhla, i-Deebio yakhe isikhungo sokuhlanza amanzi angcolile ngendlela engadini esinamandla okuhlanza nsuku zonke angu-1,000m³, namanzi angcolile akhishwayo ngemva kokufinyelela izinga.“Lesi sikhundla sanele ukuthi sisebenzise iminyaka eyishumi.Nengadi yakhiwe ngokukhethekile phezu kwesikhungo sokuhlanza amanzi angcolile.Amanzi ahlanziwe angasetshenziswa ukukhulisa izinhlanzi namanzi ezimbali,” kusho uZhang Ge ngokuziqhenya.

Ngaphezu kwalokho, igesi engcolile ingelashwa ngokufafaza nezinye izindlela, futhi i-biogas ingasetshenziswa ukushisisa kuqala ibhayela ngemva kokukhipha umoya nokuqeda amanzi emzimbeni, ngaleyo ndlela konga u-800m³ wegesi yemvelo nsuku zonke.Kuzinto eziqinile ezikhiqizwayo, kukhona ishabhu ekhethekile yokucubungula okuqinile.Imfucumfucu yamaprotheni iguqulwa ibe ngumanyolo webhayoloji phakathi nemizuzu emi-4 ngesomisi bese ithunyelwa esitshalweni sikamanyolo webhayoloji.

U-Zhang Ge uthe ngokomzwelo, “Manje yonke indawo yezitshalo ayisakhiqizi iphunga elingavamile, futhi amanzi angcolile nokungcola kulawulwa ngendlela ehlelekile.Ngiyaziqhenya ngalokhu kunokukhiqizwa kwemikhiqizo, okuyimpumelelo engiyazisa kakhulu.”

Mayelana nentuthuko yesikhathi esizayo, uZhang Ge ugcwele ukuzethemba, “Ukuthuthukiswa kwemboni kudinga inqubekelaphambili eqhubekayo.Ukuthuthukiswa kwezinga eliphezulu kwemboni ye-bio-enzyme API akusho nje kuphela ukukhiqizwa kwemikhiqizo esezingeni eliphezulu, kodwa futhi nokuba nobuchwepheshe obuthuthuke kakhulu, ukusebenza kahle kakhulu, izidingo zokuphatha eziphakeme, nezindlela zokukhiqiza ezivumelana nemvelo.U-Deebio uzothatha ubuholi bentuthuko yezinga eliphezulu yemboni njengomthwalo wayo, futhi akhonze ngenhliziyo yonke isintu ngenxa yempilo yaso endleleni yentuthuko entsha.”


Isikhathi sokuthumela: Aug-20-2021
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