He Hui Hana Hana Kūʻai mākou (CMO) ma ke Kemika a me Biotechnology

ʻO kahi hui hana ʻaelike (CMO), i kapa ʻia i kekahi manawa he ʻoihana hoʻomohala a me ka hui hana hana (CDMO), he hui e lawelawe ana i nā ʻoihana ʻē aʻe o ka ʻoihana lāʻau lapaʻau ma ke kumu ʻaelike e hāʻawi i nā lawelawe piha mai ka hoʻomohala ʻana i ka lāʻau lapaʻau ma o ka hana lāʻau.ʻAe kēia i nā hui lāʻau lapaʻau nui e hoʻopuka i kēlā mau ʻano o ka ʻoihana, hiki ke kōkua i ka scalability a i ʻole hiki ke ʻae i ka ʻoihana nui e kālele i ka loaʻa ʻana o ka lāʻau lapaʻau a me ke kūʻai aku ʻana i ka lāʻau.

Loaʻa nā lawelawe i hāʻawi ʻia e nā CMO, akā ʻaʻole i kaupalena ʻia i: pre-formulation, formulation development, stability study, method development, pre-clinical and Phase I nā mea hoʻokolohua lapaʻau, nā mea hoʻokolohua lapaʻau hope loa, kūpaʻa kūhelu, scale-up, kākau inoa. pūʻulu a me ka hana pāʻoihana.ʻO nā CMO nā mea hana aelike, akā hiki iā lākou ke ʻoi aku ma mua o kēlā ma muli o ke ʻano hoʻomohala.

ʻO ka hoʻokuʻu ʻana i kahi CMO e ʻae i ka mea kūʻai aku lāʻau lapaʻau e hoʻonui i kāna mau kumuwaiwai ʻenehana me ka ʻole o ka hoʻonui ʻana i luna.A laila hiki i ka mea kūʻai ke hoʻokele i kāna mau kumuwaiwai kūloko a me nā kumukūʻai ma ka nānā ʻana i nā mākaukau koʻikoʻi a me nā papahana waiwai kiʻekiʻe ʻoiai e hōʻemi a ʻaʻole hoʻohui i nā ʻoihana a i ʻole nā ​​​​limahana loea.Ua kūpono loa nā hui lāʻau lapaʻau maʻamau a me nā ʻoihana kūikawā i nā hui CDMO, a ke hoʻomaka nei nā hui lāʻau lapaʻau nui e nānā i nā pilina me nā CDMO ma ke ʻano he hoʻolālā ma mua o ka maʻalahi.Me ka ʻelua hapakolu o ka hana ʻana i nā lāʻau lapaʻau i hoʻopuka ʻia, a me nā mea hoʻolako makemake e loaʻa i ka ʻāpana liona, ke kau ʻia nei ke koi hou aku ma nā wahi kūikawā, ʻo ia hoʻi nā ʻano meaʻai kūikawā.

Hoʻokō Pāhana

I. ʻO CDMO i kūkulu ʻia no ka lawelawe ʻana i nā mea hoʻomohala a me nā mea kūʻai aku kālepa

II.Kūleʻa nā kūʻai i ka pilina ʻoihana

III.Manaʻo ʻia ka Project Management i ka hoʻomohala kūleʻa a me nā hoʻololi ʻenehana

IV.Hoʻololi maʻalahi mai ka pae hoʻomohala a hiki i ke kālepa

V. Nā lawelawe Client/Supply Chain i kālele ʻia i ka lako ʻoihana

He Hui ʻImi Kūkākūkā mākou (CRO) ma nā ʻoihana lāʻau lapaʻau a me Biotechnology

A Contract Research Organisation, i kapa ʻia ʻo Clinical Research Organization (CRO) he hui lawelawe e hāʻawi i ke kākoʻo i ka ʻoihana lāʻau lapaʻau a me ka biotechnology ma ke ʻano o nā lawelawe noiʻi lāʻau lapaʻau i waho (no nā lāʻau lapaʻau a me nā mea lapaʻau).Loaʻa nā CRO mai nā hui lawelawe piha nui o ka honua a hiki i nā hui kūikawā liʻiliʻi a hiki ke hāʻawi i kā lākou mea kūʻai aku i ka ʻike o ka hoʻoneʻe ʻana i kahi lāʻau a i ʻole mea hana hou mai kona manaʻo ʻana i ka ʻae ʻana i ka mākeke FDA me ka ʻole o ka mea kākoʻo lāʻau e mālama i kahi limahana no kēia mau lawelawe.

Hāʻawi ʻo LEAPchem i kahi kū hoʻokahi, a me ka laulā o nā hoʻonā i ka synthesis maʻamau, i kākoʻo ʻia e nā lawelawe loiloi honua.ʻO ka hopena he wikiwiki, palekana a kūpono hoʻi.Ke hoʻomohala nei i kahi kaʻina hana hou a i ʻole ka hoʻomaikaʻi ʻana i kahi ala synthetic i loaʻa, hiki i ka LEAPchem ke hana i ka hopena ma kēia mau wahi:

I. E ho'ēmi i ka helu o nāʻanuʻu synthetic a me nā koina

II.Hoʻonui i ka pono kaʻina hana, hua a me ka hana

III.Ke hoʻololi nei i nā kemika pōʻino a i ʻole ke kaiapuni kūpono ʻole

IV.Ke hana nei me nā molekala paʻakikī a me nā syntheses multi-step

V. Ka hoʻomohala ʻana a me ka hoʻonui ʻana i nā kaʻina hana e hana ai i nā syntheses kūpono i ka hana ʻoihana