Ukudluliswa Kwezobuchwepheshe

Ukudluliswa Kwezobuchwepheshe kanye Nokwenyusa

Ukuthuthukiswa Kwezindlela Zokuhlaziya Okugcwele

Izinqubo Eziphelele Zokukhiqiza kanye Nokwenyusa

Ukusiza ngezimfuneko ngezicelo ze-Investigational New Drug (IND).

I-Pharmaceutical Preclinical kanye ne-cGMP Technology Transfer and Development (CDMO Services)

Izinqubo Zokukhiqiza kanye Nephaneli Egcwele Yezindlela Zokuhlaziya Ukudluliselwa Kwezobuchwepheshe kusuka ku-Preclinical kuya ku-cGMP Izigaba Zomtholampilo Nezohwebo

I-Preclinical kanye ne-cGMP Technology Transfer, Scale Up, Izinqubo Zokukhiqiza kanye Nokuthuthukiswa Kwezindlela Zokuhlaziya Kubandakanya Uhlelo Lwezifundo Zokuzinza

Ukudluliswa kobuchwepheshe ku-T&T Scientific Contract Development and Manufacturing Organization (CDMO) kuhlanganisa imizamo yokuklama, ikhwalithi, kanye namathimba eminyango yokukhiqiza kusukela ekuqaleni kwamaqoqo angaphambi komtholampilo noma omtholampilo ngemisebenzi yokuthengisa kanye nakuwo wonke umjikelezo wempilo womkhiqizo. Ngesikhathi senqubo yokukhetha, sisebenzisana eduze namakhasimende ezindaweni ezibucayi azodinga i-CDMO ukulungiselela iSitatimende Somsebenzi (SOW). Le nqubo ingaba phakathi nokuhlolwa komtholampilo, isigaba I, isigaba II, kanye nesigaba III sokuhlolwa komtholampilo. Inqubo yokudlulisa ubuchwepheshe ihlanganisa ukuthola lonke ulwazi oluthuthukisiwe oluvela ocwaningweni lwamakhasimende kanye nemiphumela yelebhu, ukuhlola ubungozi, ukuthuthukiswa kwenqubo yokukhiqiza, izindlela zokuhlaziya, kanye nokuthwebula ulwazi emibikweni yezokuthuthukiswa elungiselela ukuhanjiswa kwesicelo sokulawula kanye ne-Investigational New Drug (IND).

Eqenjini lethu le-T&T Scientific, kubalulekile ukuthi ithimba lokudlulisa ubuchwepheshe lifake ochwepheshe bezihloko ezisebenza ngezindlela eziningi kusayensi eyisisekelo ye-nanoparticles, analytics, technology, regulatory, Production, kanye nokuthobela eminyangweni ehlukene yenkampani yethu. I-T&T imisa imihlangano yamasonto onke nabamele amaklayenti ukuze inikeze izibuyekezo kuyo yonke imisebenzi yesonto eledlule, ukuthuthukiswa, izinselele, imibono, nezindlela zokuya phambili zezikhathi ezifushane nezinde.

imibuzo ejwayelekile ukubuzwa

Amasevisi kanye ne-cGMP CDMO

Yiziphi Izinkonzo i-T&T Scientific ezinikeza amaklayenti ayo?

I-T&T Scientific Services Ihlanganisa Ukwakhiwa Kwangaphambi Komtholampilo, Izinqubo Zokukhiqiza kanye Nokuhlolwa Kokuhlaziya kanye Nokuthuthukiswa Kwezindlela Ngokugxila Ekulapheni NgeGene, Ukulethwa Kwezidakamizwa, kanye Nemikhiqizo Yezidakamizwa Ye-Nanomedicines.

Ingabe i-T&T Scientific Inikeza Izifundo Zokuhlaziya Nokuhlolwa?

Yebo, i-T&T Scientific inikezela ngohlu lokuhlolwa kwezilinganiso zokuhlaziya kanye nezinhlamvu, kanye nokuthuthukiswa kwezindlela zokuhlaziya ngamakhono okudlulisa ubuchwepheshe.

Ukuncintisana Kwekhotheshini (Izindleko Zizonke Ezihlobene Nezinga Lomkhakha):

I-T&T Scientific inikeza amanani ancintisana kakhulu ngokuhlinzeka ngezinqubo ezilula kakhulu zokuphatha nokukhiqiza endaweni. Ngokusekelwe Kokuncamelayo Kwekhasimende I-T&T Yesayensi Ngokuhlukile Futhi Ngokuzethemba Inikeza Izakhiwo Zezindleko Ezimbili Kumakhasimende Ayo:

  1. Isakhiwo Esisekelwe Ezikhathini Nezinto Zokusebenza: Ukwakheka Kwezindleko Zethu Ezivamile kanye Namanani Amanani Emboni Encintisana Kakhulu Nezilinganiso Zezikhathi Zabasebenzi, Izinto Ezithengwayo Zidluliswa Ngekhasimende.
  2. Isakhiwo Sezindleko Ezigxilile Zephrojekthi: Ngokusekelwe Kokuthandwayo Kwekhasimende, Siphinde Sinikeze Izindleko Zokulungisa Ezizibophezele Ngokugcwele Zephrojekthi kanye Nezinkokhelo Zeshejuli Ngokusekelwe Kokuthandwa Yikhasimende.

Ingabe i-T&T Ithuthukisa kanye Nezindlela Zokuhlaziya Zokudlulisa Ubuchwepheshe Ngokusekelwe Kumihlahlandlela ye-FDA Nokuthobelana?

Yebo. I-T&T Scientific ithuthukisa amaphaneli okuhlaziya aphelele eklayenti layo ngokusekelwe kuzinkombandlela ze-FDA ku-Nanomedicines and Gene Therapies, kanye Nemikhiqizo Yezidakamizwa Zokugoma.

Ingabe inkampani inikeza izinsizakalo zokubonisana?

Yebo, impela, ekuqaleni kwephrojekthi futhi ngokusekelwe kulokho okuthandwa yikhasimende lethu, siyakwamukela ukuqala umsebenzi ngokubonisana.

Ingabe i-T&T Scientific iyazisekela izifundo zezilwane nezinto zazo ezibonakalayo?

Yebo, uma kuziwa ekukhiqizeni, i-T&T Scientific inikezela ngokukhiqiza imikhiqizo yezidakamizwa emincane (uLs) kuya kwenkulu (i-10s of Liters +), emgqeni wesikhathi oqhudelana kakhulu nezindleko, ukuthobela kusukela ekukhiqizweni kuya kokukhiqizwa kwezentengiso.

Ingabe i-T&T Scientific iyayisekela yonke imisebenzi yokulawula ukukhiqiza nemisebenzi yamaphepha ehilelekile ekuthunyelweni kwe-IND ethobela imihlahlandlela ye-FDA?

Yebo I-T&T Scientific Support yonke imisebenzi yamaphepha edingekayo ku-CDMO yethu okuhlanganisa i-Master Batch Records (MBR), Irekhodi Leqoqo, Izinqubo, Izinqubo, Izitifiketi Zokuhlaziya (CofA), i-OOS, i-NCR, futhi inikeza umbiko ophelele wakho konke kuklayenti.

Yikuphi Ukuthuthukiswa Kwezilinganiso Zokuhlaziya kanye Nokuhlola I-T&T Yesayensi Enikezela Ngamaklayenti Ayo?

I-Wide Range of Analytical Assays Ihlinzekwa yi-T&T Scientific kanye nabalingani bayo bomhlaba wonke:

Yiziphi Izixazululo Zezinqubo Zokukhiqiza I-T&T Yesayensi Ezinikela Kubathengi Bayo?

  1. I-Solvent Injection and Tangential Flow Filtration (TFF)
  2. I-Homogenization + Umjovo we-Solvent
  3. I-Tangential Flow Filtration (TFF)
  4. I-Thin Film Hydration (TFH) + Extrusion
  5. I-Thin Film Hydration (TFH) + Homogenization (Microfluidizer)
  6. I-Thin Film Hydration (TFH) + Sonication (Ithiphu futhi Ngokuqhubekayo)
  7. I-Homogenization (I-Microfluidics)
  8. I-Sonications (Ukugeza, Ngokuqhubekayo, kanye nethiphu)
  9. Gcwalisa Oyinyumba futhi Uqede

Ayini Amandla e-T&T Scientific Ekuphathweni Kwephrojekthi noma Ezinsizeni Zeklayenti?

  1. Umhlangano Wamaviki Onke Nawo Wonke Amaklayenti Uhlelelwe Ubude Bephrojekthi
  2. Ithimba lethu Lizinikezele Ekuvaleni Ubudlelwano Nezimpendulo Zekhasimende Nezimpendulo Zansuku zonke Emahoreni angama-24 emibuzweni kanye nemibuzo yekhasimende.
  3. Kwa-T&T Scientific, siyaziqhenya ngokunakekelwa kwamakhasimende nokugxila esikunikeza ukuxhumana kwamasonto onke ngemihlangano eku-inthanethi futhi siyimise ngesikhathi sokwenza nganoma yisiphi isiphakamiso. Ithimba lonke lalo msebenzi lizobe likhona kuleyo mihlangano.
  4. Ngaphezu kwalokho, sihlala sinomuntu oshayelwa ucingo kanye nomphathi wephrojekthi wamaphrojekthi wethu wesevisi onokuqonda okujulile yonke inqubo kusukela ekukhiqizeni kuya ekulawuleni ikhwalithi (QC) kanye nokuthobelana Nokuqinisekisa Ikhwalithi (QA).

Ubuchwepheshe

Yibuphi Ubuchwepheshe Bokukhiqiza Okunikezwayo Ukudayiswa yi-T&T Scientific?

I-T&T Scientific Services Ihlanganisa Ukwakhiwa Kwangaphambi Komtholampilo, Izinqubo Zokukhiqiza kanye Nokuhlolwa Kokuhlaziya kanye Nokuthuthukiswa Kwezindlela Ngokugxila Ekulapheni NgeGene, Ukulethwa Kwezidakamizwa, kanye Nemikhiqizo Yezidakamizwa Ye-Nanomedicines.

I-NanoSizer Extrusion Technologies (MINI, STERILE, AUTOs)

  1. I-NanoSizer FLOW Solvent Injection Technology Platform (BLINK, CHANNEL, GMP)
    • BLINK: Isikali Esincane sisuka ku-UL siye ku-10 wamamililitha
    • CHANNEL: Isikali Esincane sisuka ku-UL siye ku-10s samamililitha Enziwe ngokwezifiso Ukulawulwa Kwezinga Lokushisa kanye Nokwehliswa Kwe-Inline
    • I-GMP (KONKE NGENYE): Isilinganiso Esincane Kuya Esikhulu Esinawo Wonke Amakhono Ahlanganisayo, Ikhompyutha Yezimboni, kanye Neplathifomu Yesofthiwe
  1. I-NanoSizer Extrusion Technologies (MINI, STERILE, AUTOs)
    • I-MINI: Eyokuqala Emhlabeni Ehlanganiswe Ngokugcwele Ivolumu Efile I-Liposome Extruder
    • INJAMBI: I-Liposome Enziwe Inzalo kanye Ne-Lipid Extruder Yezinhlelo Zokusebenza Ezidinga Ukuzala, Okufana Nemisebenzi Yeseli, I-Exosomes, Njll.
    • NanoSizer AUTO I: I-Automated Liposome Extruder Ideal Ephelele ene-1-10mL Batch kanye Nosayizi Wokugijima
    • I-NanoSizer AUTO X: I-Automated Liposome Extruder Ideal Ephelele ene-10mL-200mL Batch kanye Nosayizi Wokugijima
    • I-NanoSizer AUTO Plus: I-Automated Liposome Extruder Ideal Ephelele ene-10mL-200mL Batch kanye Nosayizi Wokugijima

Yimuphi Umqondo osetshenziswa yi-Solvent Injection Technology, i-NanoSizer FLOW, ukukhiqiza Imikhiqizo Yezidakamizwa Ye-Nanoparticle?

I-T&T Scientific FLOW technologies isebenzisa ukuxuba ukugeleza kweziyaluyalu Technologies ubuchwepheshe obulungiselelwe kanye nobunikazi bokukhiqiza imikhiqizo yezidakamizwa ze-nanoparticle enekhwalithi ephezulu, i- throughput ephezulu, kanye ne-overhead ephansi.

Ukuqinisekisa Ikhwalithi Nokulawulwa Kwekhwalithi

I-T&T Scientific Ihlolwe Izikhathi Eziyisihlanu Ngamakhasimende e-cGMP Futhi Yasingathwa Ngempumelelo Konke Okutholakele Okukhulu Nokuncane phakathi kwezinsuku ezingama-30 nezingama-60 Zocwaningomabhuku, Ngokulandelana. Kube nevelakancane kunoma yikuphi okutholwe okukhulu ngesikhathi socwaningomabhuku olwenziwe kwa-T&T Scientific.

Ingabe ukhona umnyango ozimele Wokulawulwa Kwekhwalithi/Ukuqinisekisa Ikhwalithi?

Yebo, i-T&T Scientific inabo abasebenzi kanye nesistimu yekhwalithi kanye nomnyango osebenza ngokuzimela kweminye iminyango. Inhloko Yokuqinisekisa Ikhwalithi kwa-T&T Scientific inesibopho sokuthobela umsebenzi owenzeka kwa-T&T Scientific; kanye neNhloko Yokulawulwa Kwekhwalithi ngokuzimele enesibopho sokuhlola izilawuli zekhwalithi yemikhiqizo nemibiko yezibalo. I-T&T CDMO Space and Sector ku-T&T Scientific ihlukaniswe yaba iminyango emithathu ezimele 1) Imisebenzi Yokukhiqiza, 2) Ukuqinisekisa Ikhwalithi, kanye 3) Nokulawulwa Kwekhwalithi.

Yiziphi Izinhlelo Zokulawula Ikhwalithi ze-T&T Scientific Ezithobelana nazo?

Umnyango ngamunye uyiyunithi yokusebenza ehlukene yenhlangano, futhi indlela yekhwalithi eyisisekelo iwumongo wakho konke esikwenzayo lapha. Imisebenzi Yekhwalithi ye-T&T ibuswa Yimanuwali Yekhwalithi yesayithi. I-T&T Scientific Corporation's Quality Management System ithatha isiqondiso ku-21 CFR Part 820 Quality System Regulations futhi ithobela zonke izimfuneko zokulawula ze-FDA GMP ezihlanganisa 21 CFR Ingxenye 210, 21 CFR Ingxenye 211, kanye 21 CFR Ingxenye 11. Inkampani ithi akukho okushiyelwe ku-21 CFR Ingxenye 820, 201, 211, 11 ku-7140 Regal Lane, Knoxville, TN 37918.

Yiziphi Izinqubomgomo Zekhwalithi ze-T&T Scientific?

  • Gqugquzela umqondo wekhwalithi okhuthaza uthando lokuthuthuka okuqhubekayo.
  • Qinisekisa ukuthobela zonke izimfuneko zokulawula ezisebenzayo.
  • Qinisekisa imikhiqizo ephephile nesebenzayo namasevisi agcwalisa izidingo zamakhasimende.

Ingabe i-T&T Scientific Inesistimu Yokulawula Ikhwalithi Ye-elekthronikhi?

  • Yebo I-T&T Scientific Isebenzisa Uhlelo Oluphezulu Lokuphathwa Kwekhwalithi Ye-elekthronikhi (i-Qualio) Njengohlelo Lwalo Lokuphathwa Kwekhwalithi Ye-elekthronikhi Luthobelana Ngokugcwele Nezimfuneko ze-FDA.

Ingabe Iziqu Nezinsizakalo Zokuqinisekisa Ezinikezwa I-NanoSizer FLOW Technologies

Yebo, UMnyango Wekhwalithi Yezesayensi we-T&T unikeza ukufakwa okuphelele, ukuqeqeshwa, iziqu ngezikhathi ezithile kanye nezinsizakalo zokuqinisekisa zobuchwepheshe be-NanoSizer FLOW.

I-T&T Scientific Ike Yacwaningwa Kangaki Esikhathini Esidlule?

I-T&T Scientific Ihlolwe Ngempumelelo Izikhathi Eziyisihlanu yi-cGMP Amaklayenti Emithi Amancane Kuya Kwamakhulu Futhi Yasingathwa Ngempumelelo Konke Okutholwe Okukhulu Nokuncane phakathi kwezinsuku ezingama-30 nezingama-60 Zocwaningomabhuku, Ngokulandelana. Kube nevelakancane kunoma yikuphi okutholwe okukhulu ngesikhathi socwaningomabhuku olwenziwe kwa-T&T Scientific

Ingabe i-T&T Scientific Inazo Izinhlelo Zokuqeqeshwa Kwezisebenzi Ezithize?

I-T&T Scientific Konke Ngaphansi Kophahla Olulodwa Ukukhiqiza Kwe-GMP Igxile Kakhulu Ekuqeqesheni Kwabasebenzi Nezinhlelo Zayo Zokuqeqesha Ezihlelekile, I-Matrix Ichaza, Izitimela, Futhi Ihlola Zonke Izindima Ngokucophelela Enhlanganweni.

Ingabe i-T&T Scientific Yenza Ukuzihlola Okuphindaphindiwe Kwangaphakathi Nezinkampani Zasesithathu?

I-T&T Scientific inocwaningomabhuku olwenziwa izikhathi eziningi ngonyaka ngaphakathi ukuze kuqinisekiswe ukuthotshelwa kwemithetho yakamuva. Lokhu kucwaningwa kwamabhuku kwenziwa wumnyango wokuqinisekisa ikhwalithi nokuhambisana.

 

I-T&T Scientific Iphenya Kanjani Ukusebenza/Imikhiqizo Nemibiko Yangaphakathi Engavumelani?

I-T&T Scientific Ihlolwe Izikhathi Eziyisihlanu Ngamakhasimende e-cGMP Futhi Yasingathwa Ngempumelelo Konke Okutholakele Okukhulu Nokuncane phakathi kwezinsuku ezingama-30 nezingama-60 Zocwaningomabhuku, Ngokulandelana. Kube nevelakancane kunoma yikuphi okutholwe okukhulu ngesikhathi socwaningomabhuku olwenziwe kwa-T&T Scientific.

Ingabe i-T&T Scientific, Ngokwesisekelo Esivamile, Ibuyekeza Ama-SOP, Amaphrothokholi, Nezinqubo?

Yebo, Umnyango Wekhwalithi Yezesayensi we-T&T Hlangana njalo ngesonto, nyanga zonke, kanye nangekota futhi uhlale uvumelana ngaso sonke isikhathi.

Ingabe Uhlelo Lokuphathwa Kwekhwalithi Yezesayensi lwe-T&T luyasetshenziswa futhi Imikhuba Iyashintsha Ukulawula kanye Nokulandelelwa Okuphelele?

I-T&T Scientific Ihlolwe Izikhathi Eziyisihlanu Ngamakhasimende e-cGMP Futhi Yasingathwa Ngempumelelo Konke Okutholakele Okukhulu Nokuncane phakathi kwezinsuku ezingama-30 nezingama-60 Zocwaningomabhuku, Ngokulandelana. Kube nevelakancane kunoma yikuphi okutholwe okukhulu ngesikhathi socwaningomabhuku olwenziwe kwa-T&T Scientific.

Ingabe i-T&T Scientific Ine-Compliant Document Control, Ukubuyisa kanye Nesitoreji?

I-T&T Scientific Ihlolwe Izikhathi Eziyisihlanu Ngamakhasimende e-cGMP Futhi Yasingathwa Ngempumelelo Konke Okutholakele Okukhulu Nokuncane phakathi kwezinsuku ezingama-30 nezingama-60 Zocwaningomabhuku, Ngokulandelana. Kube nevelakancane kunoma yikuphi okutholwe okukhulu ngesikhathi socwaningomabhuku olwenziwe kwa-T&T Scientific.

Ukukhiqiza-Izinto Ezingavuthiwe / Ukulawula Izingxenye?

I-T&T Scientific Ihlolwe Izikhathi Eziyisihlanu Ngamakhasimende e-cGMP Futhi Yasingathwa Ngempumelelo Konke Okutholakele Okukhulu Nokuncane phakathi kwezinsuku ezingama-30 nezingama-60 Zocwaningomabhuku, Ngokulandelana. Kube nevelakancane kunoma yikuphi okutholwe okukhulu ngesikhathi socwaningomabhuku olwenziwe kwa-T&T Scientific.

Izilawuli Zokuhlola Nezinqubo

Iyabuyekeza.....

Amakhono Namakhono

Ibuyekeza ...

Qala Lapha

Isivumelwano Sethu Esihlanganyelwe Sokungadaluli (Ongakukhetha)

Xhumana nathi ukuze uqalise lapha

Ukwakhiwa kanye Nezinhlelo Zokulethwa Kwezidakamizwa
Ukuklama Nokuthuthukisa
Ukudlulisa Ubuchwepheshe:
Ukuthuthukiswa Kwezindlela Zokuhlaziya
Ukukhiqiza Process
Ukuthuthukisa kanye Nokukhulisa
Ukudlulisa Ubuchwepheshe:
Ukuthuthukiswa Kwenqubo Yokukhiqiza

Ukudluliswa Nokuthuthukiswa Kwezobuchwepheshe Bezemithi

Izinqubo Zokukhiqiza kanye Nokuthuthukiswa Kwezindlela Zokuhlaziya kusukela ku-Preclinical kuya ku-cGMP Clinical and Commercialization

Ukudluliswa kobuchwepheshe ku-T&T Scientific Contract Development and Manufacturing Organization (CDMO) kuhlanganisa imizamo yokuklama, ikhwalithi, kanye namathimba eminyango yokukhiqiza kusukela ekuqaleni kwamaqoqo angaphambi komtholampilo noma omtholampilo ngemisebenzi yokuthengisa kanye nakuwo wonke umjikelezo wempilo womkhiqizo. Ngesikhathi senqubo yokukhetha, sisebenzisana eduze namakhasimende ezindaweni ezibucayi azodinga i-CDMO ukulungiselela iSitatimende Somsebenzi (SOW). Le nqubo ingaba phakathi nokuhlolwa komtholampilo, isigaba I, isigaba II, kanye nesigaba III sokuhlolwa komtholampilo. Inqubo yokudlulisa ubuchwepheshe ihlanganisa ukuthola lonke ulwazi oluthuthukisiwe oluvela ocwaningweni lwamakhasimende kanye nemiphumela yelebhu, ukuhlola ubungozi, ukuthuthukiswa kwenqubo yokukhiqiza, izindlela zokuhlaziya, kanye nokuthwebula ulwazi emibikweni yezokuthuthukiswa elungiselela ukuhanjiswa kwesicelo sokulawula kanye ne-Investigational New Drug (IND).

Eqenjini lethu le-T&T Scientific, kubalulekile ukuthi ithimba lokudlulisa ubuchwepheshe lifake ochwepheshe bezihloko ezisebenza ngezindlela eziningi kusayensi eyisisekelo ye-nanoparticles, analytics, technology, regulatory, Production, kanye nokuthobela eminyangweni ehlukene yenkampani yethu. I-T&T imisa imihlangano yamasonto onke nabamele amaklayenti ukuze inikeze izibuyekezo kuyo yonke imisebenzi yesonto eledlule, ukuthuthukiswa, izinselele, imibono, nezindlela zokuya phambili zezikhathi ezifushane nezinde.

imibuzo ejwayelekile ukubuzwa

Imisebenzi

Yiziphi Izinkonzo i-T&T Scientific ezinikeza amaklayenti ayo?

I-T&T Scientific Services Ihlanganisa Ukwakhiwa Kwangaphambi Komtholampilo, Izinqubo Zokukhiqiza kanye Nokuhlolwa Kokuhlaziya kanye Nokuthuthukiswa Kwezindlela Ngokugxila Ekulapheni NgeGene, Ukulethwa Kwezidakamizwa, kanye Nemikhiqizo Yezidakamizwa Ye-Nanomedicines.

Ingabe i-T&T Scientific Inikeza Izifundo Zokuhlaziya Nokuhlolwa?

Yebo, i-T&T Scientific inikezela ngohlu lokuhlolwa kwezilinganiso zokuhlaziya kanye nezinhlamvu, kanye nokuthuthukiswa kwezindlela zokuhlaziya ngamakhono okudlulisa ubuchwepheshe.

Ukuncintisana Kwekhotheshini (Izindleko Zizonke Ezihlobene Nezinga Lomkhakha):

I-T&T Scientific inikeza amanani ancintisana kakhulu ngokuhlinzeka ngezinqubo ezilula kakhulu zokuphatha nokukhiqiza endaweni. Ngokusekelwe Kokuncamelayo Kwekhasimende I-T&T Yesayensi Ngokuhlukile Futhi Ngokuzethemba Inikeza Izakhiwo Zezindleko Ezimbili Kumakhasimende Ayo:

  1. Isakhiwo Esisekelwe Ezikhathini Nezinto Zokusebenza: Ukwakheka Kwezindleko Zethu Ezivamile kanye Namanani Amanani Emboni Encintisana Kakhulu Nezilinganiso Zezikhathi Zabasebenzi, Izinto Ezithengwayo Zidluliswa Ngekhasimende.
  2. Isakhiwo Sezindleko Ezigxilile Zephrojekthi: Ngokusekelwe Kokuthandwayo Kwekhasimende, Siphinde Sinikeze Izindleko Zokulungisa Ezizibophezele Ngokugcwele Zephrojekthi kanye Nezinkokhelo Zeshejuli Ngokusekelwe Kokuthandwa Yikhasimende.

Ingabe i-T&T Ithuthukisa kanye Nezindlela Zokuhlaziya Zokudlulisa Ubuchwepheshe Ngokusekelwe Kumihlahlandlela ye-FDA Nokuthobelana?

Yebo. I-T&T Scientific ithuthukisa amaphaneli okuhlaziya aphelele eklayenti layo ngokusekelwe kuzinkombandlela ze-FDA ku-Nanomedicines and Gene Therapies, kanye Nemikhiqizo Yezidakamizwa Zokugoma.

Ingabe inkampani inikeza izinsizakalo zokubonisana?

Yebo, impela, ekuqaleni kwephrojekthi futhi ngokusekelwe kulokho okuthandwa yikhasimende lethu, siyakwamukela ukuqala umsebenzi ngokubonisana.

Ingabe i-T&T Scientific iyazisekela izifundo zezilwane nezinto zazo ezibonakalayo?

Yebo, uma kuziwa ekukhiqizeni, i-T&T Scientific inikezela ngokukhiqiza imikhiqizo yezidakamizwa emincane (uLs) kuya kwenkulu (i-10s of Liters +), emgqeni wesikhathi oqhudelana kakhulu nezindleko, ukuthobela kusukela ekukhiqizweni kuya kokukhiqizwa kwezentengiso.

Ingabe i-T&T Scientific iyayisekela yonke imisebenzi yokulawula ukukhiqiza nemisebenzi yamaphepha ehilelekile ekuthunyelweni kwe-IND ethobela imihlahlandlela ye-FDA?

Yebo I-T&T Scientific Support yonke imisebenzi yamaphepha edingekayo ku-CDMO yethu okuhlanganisa i-Master Batch Records (MBR), Irekhodi Leqoqo, Izinqubo, Izinqubo, Izitifiketi Zokuhlaziya (CofA), i-OOS, i-NCR, futhi inikeza umbiko ophelele wakho konke kuklayenti.

Yikuphi Ukuthuthukiswa Kwezilinganiso Zokuhlaziya kanye Nokuhlola I-T&T Yesayensi Enikezela Ngamaklayenti Ayo?

I-Wide Range of Analytical Assays Ihlinzekwa yi-T&T Scientific kanye nabalingani bayo bomhlaba wonke:

Yiziphi Izixazululo Zezinqubo Zokukhiqiza I-T&T Yesayensi Ezinikela Kubathengi Bayo?

  1. I-Solvent Injection and Tangential Flow Filtration (TFF)
  2. I-Homogenization + Umjovo we-Solvent
  3. I-Tangential Flow Filtration (TFF)
  4. I-Thin Film Hydration (TFH) + Extrusion
  5. I-Thin Film Hydration (TFH) + Homogenization (Microfluidizer)
  6. I-Thin Film Hydration (TFH) + Sonication (Ithiphu futhi Ngokuqhubekayo)
  7. I-Homogenization (I-Microfluidics)
  8. I-Sonications (Ukugeza, Ngokuqhubekayo, kanye nethiphu)
  9. Gcwalisa Oyinyumba futhi Uqede

Ayini Amandla e-T&T Scientific Ekuphathweni Kwephrojekthi noma Ezinsizeni Zeklayenti?

  1. Umhlangano Wamaviki Onke Nawo Wonke Amaklayenti Uhlelelwe Ubude Bephrojekthi
  2. Ithimba lethu Lizinikezele Ekuvaleni Ubudlelwano Nezimpendulo Zekhasimende Nezimpendulo Zansuku zonke Emahoreni angama-24 emibuzweni kanye nemibuzo yekhasimende.
  3. Kwa-T&T Scientific, siyaziqhenya ngokunakekelwa kwamakhasimende nokugxila esikunikeza ukuxhumana kwamasonto onke ngemihlangano eku-inthanethi futhi siyimise ngesikhathi sokwenza nganoma yisiphi isiphakamiso. Ithimba lonke lalo msebenzi lizobe likhona kuleyo mihlangano.
  4. Ngaphezu kwalokho, sihlala sinomuntu oshayelwa ucingo kanye nomphathi wephrojekthi wamaphrojekthi wethu wesevisi onokuqonda okujulile yonke inqubo kusukela ekukhiqizeni kuya ekulawuleni ikhwalithi (QC) kanye nokuthobelana Nokuqinisekisa Ikhwalithi (QA).

Ubuchwepheshe

15,000 SQ.FT. KONKE NGAPHANSI KOKUSEBENZA KWE-GMP OLULODWA

IMIKHIQIZO OKUFAKIWE

UKUBUYEKEZA UKUFUNDA

Good!

Ama-headphone mahle, alula kakhulu futhi nekhwalithi yomsindo iyamangalisa.

- Kevin Smith

Ukushintsha ngokushesha

Umkhiqizo omuhle wama-apula ngentengo encintisana kakhulu. Uku-oda ku-inthanethi bekuheleza umoya futhi ngakwazi ukuqoqa zingakapheli izinsuku ezi-2 ngifake i-oda lami.

- Luke Johnson

Bathande

Ziqaphele njengoba zingalahleka kalula futhi ziwele ezindaweni ezingahleliwe njengoba zincane kakhulu.

- UJenny Black

OKUthrendayo MANJE

BHALISELA IVANGELI LETHU

Thola ukukhishwa kwethu kweviki kwakamuva, iminikelo, imihlahlandlela nokunye okwengeziwe.

Ngiyabonga!