SiyiNhlangano Yokukhiqiza Izinkontileka (i-CMO) kuKhemistry kanye ne-Biotechnology

Inhlangano ekhiqiza izinkontileka (i-CMO), ngezinye izikhathi ebizwa ngokuthi i-contract Development and Manufacturing Organisation (CDMO), yinkampani esebenzela ezinye izinkampani embonini yezemithi ngenkontileka ukuze inikeze izinsiza eziphelele kusukela ekuthuthukisweni kwezidakamizwa ngokukhiqiza izidakamizwa.Lokhu kuvumela izinkampani ezinkulu zemithi ukuthi zikhiphe lezo zici zebhizinisi, ezingasiza ngokuncipha noma ezingavumela inkampani enkulu ukuthi igxile ekutholakaleni kwezidakamizwa nasekukhangiseni izidakamizwa esikhundleni salokho.

Izinsizakalo ezihlinzekwa ama-CMOs zihlanganisa, kodwa azikhawulelwe kulokhu: ukwakhiwa kwangaphambili, ukuthuthukiswa kokwakhiwa, izifundo zokuzinza, ukuthuthukiswa kwezindlela, izinto zokuhlola umtholampilo zangaphambi komtholampilo kanye neSigaba I, izinto zokuhlolwa komtholampilo ezifika sekwephuzile, ukuzinza okusemthethweni, ukukhuphuka, ukubhaliswa. amaqoqo kanye nokukhiqizwa kwezohwebo.Ama-CMO angabakhiqizi bezinkontileka, kodwa futhi angaba ngaphezu kwalokho ngenxa yesici sokuthuthukiswa.

Ukukhishwa kwemisebenzi ku-CMO kuvumela iklayenti lezemithi ukuthi landise izinsiza zalo zobuchwepheshe ngaphandle kokukhuphuka okungaphezulu.Iklayenti lingakwazi ke ukuphatha izinsiza zalo zangaphakathi kanye nezindleko ngokugxila ekwazisweni okuyisisekelo namaphrojekthi anenani eliphezulu kuyilapho lehlisa noma lingangezi ingqalasizinda noma abasebenzi bezobuchwepheshe.Izinkampani zemithi ezingokoqobo nezikhethekile zikufanelekela kahle kakhulu ukusebenzisana kwe-CDMO, futhi izinkampani ezinkulu zemithi seziqala ukubuka ubudlelwano nama-CDMO njengobuqhinga kunokuba bube ngamasu.Njengoba izingxenye ezimbili kwezintathu zokwenziwa kwemithi zikhishwa ngaphandle, nabahlinzeki abakhethwayo abathola isabelo sebhubesi, isidingo esengeziwe sibekwa ezindaweni ezikhethekile, okungukuthi amafomu omthamo okhethekile.

Ukwenziwa Kwephrojekthi

I. I-CDMO yakhelwe ukusevisa kokubili amakhasimende entuthuko nawezohwebo

II.Ukuthengisa kugxile ebudlelwaneni bebhizinisi

III.Ukuphathwa Kwephrojekthi kugxile ekuthuthukisweni okuyimpumelelo nokudluliselwa kobuchwepheshe

IV.Ukudluliswa okubushelelezi kusuka esigabeni sokuthuthukiswa kuye kwezentengiso

V. Izinsizakalo Zekhasimende/I-Supply Chain igxile ekuhlinzekeni ngezohwebo

SiyiNhlangano Yokucwaninga Ngenkontileka (i-CRO) ezimbonini zezemithi kanye ne-Biotechnology

I-Contract Research Organisation, ebizwa nangokuthi i-Clinical Research Organisation (CRO) yinhlangano yesevisi ehlinzeka ngokusekela izimboni zemithi kanye ne-biotechnology ngendlela yezinsizakalo zocwaningo lwezemithi ezinikezwa ngaphandle (kokubili izidakamizwa kanye nemishini yezokwelapha).Ama-CRO asukela ezinhlanganweni ezinkulu zomhlaba jikelele ezihlinzeka ngemisebenzi egcwele kuya emaqenjini amancane, akhethekile futhi anganikeza amakhasimende awo ulwazi lokuhambisa umuthi noma idivayisi entsha kusukela ekuqanjweni kwawo ukuya emvumeni yokuthengisa ye-FDA ngaphandle kokuthi umxhasi wezidakamizwa agcine isisebenzi salezi zinsizakalo.

I-LEAPChem ihlinzeka ngokuma okukodwa, kanye nohlu olubanzi lwezixazululo ekuhlanganiseni ngokwezifiso, ezisekelwa izinsizakalo zokuhlaziya ezisezingeni lomhlaba.Umphumela uyashesha, uphephile futhi usezingeni eliphezulu.Noma ngabe ithuthukisa inqubo entsha noma ithuthukisa umzila wokwenziwa okhona, i-LEAPChem ingaba nomthelela kulezi zindawo ezilandelayo:

I. Ukunciphisa inani lezinyathelo zokwenziwa kanye nezindleko

II.Ukwandisa ukusebenza kahle kwenqubo, isivuno kanye nokuphuma phambili

III.Ukushintsha amakhemistri ayingozi noma angafanelekile ngokwendawo

IV.Ukusebenza ngama-molecule ayinkimbinkimbi kanye nama-multi-step syntheses

V. Ukuthuthukisa kanye nokwenza kahle izinqubo ezikhona ukuze kukhiqizwe ama-syntheses avumela ukukhiqizwa kwezentengiselwano