Re Mokhatlo oa Tlhahiso ea Likonteraka (CMO) oa Chemistry le Biotechnology

Mokhatlo oa tlhahiso ea likonteraka (CMO), oo ka linako tse ling o bitsoang mokhatlo oa ntlafatso le tlhahiso ea konteraka (CDMO), ke khamphani e sebeletsang lik'hamphani tse ling indastering ea meriana ka konteraka ea ho fana ka litšebeletso tse felletseng ho tloha ntlafatsong ea lithethefatsi ka tlhahiso ea lithethefatsi.Sena se lumella lik'hamphani tse kholo tsa meriana ho fana ka likarolo tseo tsa khoebo, tse ka thusang ka scalability kapa tse ka lumellang k'hamphani e kholo ho tsepamisa maikutlo ho sibolloeng ha lithethefatsi le ho bapatsa ka lithethefatsi.

Litšebeletso tse fanoang ke li-CMO li kenyelletsa, empa ha li felle feela ho: tlhophiso ea pele, nts'etsopele ea tlhahiso, lithuto tsa botsitso, nts'etsopele ea mekhoa, lisebelisoa tsa teko ea pele ho tleliniki le Phase I, lisebelisoa tsa liteko tsa kliniki tsa morao-rao, botsitso ba semmuso, ho eketseha, ho ngolisoa. lihlopha le tlhahiso ea khoebo.Li-CMO ke baetsi ba likonteraka, empa hape ba ka ba tse fetang tseo ka lebaka la karolo ea ntlafatso.

Ts'ebeliso ea kantle ho CMO e lumella moreki oa meriana ho holisa lisebelisoa tsa eona tsa tekheniki ntle le ho eketseha ho hoholo.Joale moreki a ka khona ho laola lisebelisoa tsa hae tsa kahare le litšenyehelo ka ho tsepamisa maikutlo ho litsebo tsa mantlha le merero ea boleng bo holimo ha a ntse a fokotsa kapa a sa eketse lisebelisoa kapa basebetsi ba mahlale.Likhamphani tse sebetsang hantle le tse ikhethang tsa meriana li loketse hantle litšebelisano tsa CDMO, 'me lik'hamphani tse kholo tsa meriana li se li qala ho talima likamano le li-CDMO e le tsa maano ho fapana le ho ba maqheka.Ha karolo ea bobeli ho tse tharo ea tlhahiso ea meriana e rekisoa kantle ho naha, 'me barekisi ba khethiloeng ba fumana karolo ea tau, tlhokahalo e eketsehileng e ntse e beoa libakeng tse ikhethileng, ke hore, liforomo tsa litekanyetso tse khethehileng.

Phethahatso ea Morero

I. CDMO e hahiloe ho sebeletsa bareki ba nts'etsopele le ba khoebo

II.Lithekiso li ne li shebane le kamano ea khoebo

III.Tsamaiso ea Morero e tsepamisitse maikutlo ntlafatsong e atlehileng le phetisetso ea theknoloji

IV.Phetiso e bonolo ho tloha mohatong oa nts'etsopele ho ea khoebong

V. Litšebeletso tsa Client/Supply Chain li ne li shebane le phepelo ea khoebo

Re Mokhatlo oa Lipatlisiso tsa Konteraka (CRO) Lefapheng la Pharmaceutical and Biotechnology Industries

Mokhatlo oa Lipatlisiso tsa Konteraka, oo hape o bitsoang Clinical Research Organisation (CRO) ke mokhatlo oa litšebeletso o fanang ka tšehetso ho indasteri ea meriana le biotechnology ka mokhoa oa litšebeletso tsa lipatlisiso tsa meriana (bakeng sa meriana le lisebelisoa tsa bongaka).Li-CRO li tloha mekhatlong e meholo, ea machaba ea litšebeletso tse feletseng ho ea ho lihlopha tse nyenyane tse khethehileng tsa niche 'me li ka fa bareki ba bona phihlelo ea ho tsamaisa lithethefatsi kapa sesebelisoa se secha ho tloha kemolong ea sona ho ea ho tumello ea papatso ea FDA ntle le hore mofani oa lithethefatsi a tlameha ho boloka basebetsi bakeng sa litšebeletso tsena.

LEAPChem e fana ka tharollo e le 'ngoe, le mefuta e mengata e fapaneng ea litharollo tsa moetlo, tse tšehetsoang ke lits'ebeletso tsa tlhahlobo ea maemo a lefats'e.Sephetho se potlakisa, se bolokehile ebile se sebetsa hantle.Hore na e nts'etsapele tšebetso e ncha kapa e ntlafatsa tsela e teng ea maiketsetso, LEAPChem e ka ba le tšusumetso libakeng tse latelang:

I. Ho fokotsa palo ea mehato ea maiketsetso le litšenyehelo

II.Ho eketsa ts'ebetso ea ts'ebetso, tlhahiso le tlhahiso

III.Ho nkela dikhemistri tse kotsi kapa tse sa lokang tikolohong

IV.Ho sebetsa ka limolek'hule tse rarahaneng le li-syntheses tsa mehato e mengata

V. Ho nts'etsapele le ho ntlafatsa lits'ebetso tse teng ho hlahisa li-syntheses tse loketseng tlhahiso ea khoebo