SinguMbutho wokuVelisa ikhontrakthi (CMO) kwiKhemistry kunye neBiotechnology

Umbutho wokwenziwa kwekhontrakthi (i-CMO), maxa wambi ebizwa ngokuba luphuhliso lwekhontrakthi kunye nombutho wokuvelisa (CDMO), yinkampani esebenzela ezinye iinkampani kushishino loxubo mayeza ngokwekhontrakthi ukubonelela ngeenkonzo ezibanzi ezisuka kuphuhliso lwamachiza ngokwenza amachiza.Oku kuvumela iinkampani ezinkulu zoxubo-mayeza ukuba zikhuphe ngaphandle kwezo nkalo zeshishini, ezinokunceda ngokukaleka okanye ezinokuvumela inkampani enkulu ukuba igxile ekufumaneni amachiza kunye nokuthengisa amachiza endaweni yoko.

Iinkonzo ezinikezelwa yi-CMOs zibandakanya, kodwa aziphelelanga koku: ukuqulunqwa kwangaphambili, uphuhliso loqulunqo, izifundo zozinzo, uphuhliso lweendlela, izixhobo zovavanyo lweklinikhi zangaphambi kweklinikhi kunye neSigaba soku-I, izixhobo zovavanyo lweklinikhi zasemva kwexesha, uzinzo olusesikweni, ukunyuka, ukubhaliswa. iibhetshi kunye nemveliso yorhwebo.IiCMO ngabavelisi bekhontrakthi, kodwa banokuba ngaphezulu koko ngenxa yenkalo yophuhliso.

Ukukhutshwa kwemisebenzi kwi-CMO kuvumela umxhasi wezoxubo ukuba andise izixhobo zobugcisa ngaphandle kokunyuka okuphezulu.Emva koko umxhasi unokulawula izixhobo zakhe zangaphakathi kunye neendleko ngokugxininisa ubuchule obuphambili kunye neeprojekthi zexabiso eliphezulu ngelixa unciphisa okanye ungongezi iziseko okanye abasebenzi bezobugcisa.Iinkampani ezixuba amayeza ezizizo kunye nezikhethekileyo zilungele intsebenziswano yeCDMO, kwaye iinkampani ezinkulu zoxubo-mayeza ziqala ukujonga ubudlelwane kunye neeCDMO njengobuchule kunokuba bube bubuchule.Ngesibini esithathwini sokwenziwa kwamayeza angaphandle, kunye nababoneleli abakhethwayo abafumana isabelo sengonyama, imfuno eyongezelelweyo ibekwa kwiindawo ezizodwa, oko kukuthi iifomu zedosi eyodwa.

Ukwenziwa kweProjekthi

I. CDMO yakhelwe inkonzo zombini uphuhliso & abathengi yorhwebo

II.Intengiso igxile kubudlelwane boshishino

III.Ulawulo lweProjekthi lujolise kuphuhliso oluyimpumelelo kunye nokudluliselwa kobugcisa

IV.Ukutshintshwa okungenamagingxigingxi ukusuka kwinqanaba lophuhliso ukuya kwintengiso

V. Iinkonzo zabaxhamli/ziBonelelo zijolise ekuboneleleni ngezorhwebo

SinguMbutho woPhando lwekhontrakthi (CRO) kuShishino lwezaMayeza kunye neBiyotechnology

Umbutho woPhando lwekhontrakthi, ekwabizwa ngokuba yiClinical Research Organisation (CRO) ngumbutho wenkonzo obonelela ngenkxaso kumashishini amayeza kunye ne-biotechnology ngendlela yeenkonzo zophando lwamayeza angaphandle (kuzo zombini amachiza kunye nezixhobo zonyango).Ii-CROs zisuka kwimibutho emikhulu, yamazwe ngamazwe yenkonzo epheleleyo ukuya kwimibutho emincinci, i-niche ekhethekileyo kwaye inokunika abathengi babo amava okuhambisa iyeza elitsha okanye isixhobo ukusuka ekukhawulweni kwayo ukuya kwimvume yokuthengisa ye-FDA ngaphandle kokuba umxhasi weziyobisi agcine abasebenzi bezi nkonzo.

I-LEAPChem inikezela nge-stop-stop, kunye noluhlu olubanzi lwezisombululo kwi-custom synthesis, exhaswa ngeenkonzo zokuhlalutya ezikumgangatho wehlabathi.Isiphumo sikhawuleza, sikhuselekile kwaye sisebenza ngokufanelekileyo isikali-sonyuso.Nokuba iphuhlisa inkqubo entsha okanye iphucula indlela esele ikhona, iLEAPChem ingenza impembelelo kwezi ndawo zilandelayo:

I. Ukunciphisa inani lamanyathelo okwenziwa kunye neendleko

II.Ukwandisa ukusebenza kakuhle kwenkqubo, isivuno kunye nesiphumo

III.Ukutshintsha iikhemistri ezinobungozi okanye ezingafanelekanga ngokwendalo

IV.Ukusebenza kunye neemolekyuli ezinzima kunye ne-multi-step syntheses

V. Ukuphuhlisa nokuphucula iinkqubo ezikhoyo ukuze kuveliswe amaqumrhu afanelekileyo kwimveliso yorhwebo