Ho fetisoa ha theknoloji

Phetisetso ea Theknoloji le Ho Eketsa
Tsoelo-pele ea Mekhoa ea Tlhahlobo e Feletseng
Mekhoa e Felletseng ea Tlhahiso le Ho Eketsa
Ho Thusa ka Litlhoko ka Likopo tsa Investigational New Drug (IND).

Ho fetisoa ha theknoloji

Phetisetso ea Theknoloji le Ho Eketsa
Tsoelo-pele ea Mekhoa ea Tlhahlobo e Feletseng
Mekhoa e Felletseng ea Tlhahiso le Ho Eketsa
Ho thusa ka Litlhoko ka
Likopo tsa ho Batlisisa Lithethefatsi tse Ncha (IND).
Pharmaceutical Preclinical le cGMP Technology Transfer and Development (CDMO Services)

Mekhoa ea Tlhahiso le Phanele e Felletseng ea Ts'ebetso ea Ts'ebetso ea Ts'ebetso ea Ts'ebetso ea Ts'ebetso ho tloha Preclinical ho ea ho CGMP Clinical and Commercialization Stages.

Phetisetso ea Theknoloji ea Preclinical le cGMP, Scale Up, Mekhoa ea Tlhahiso le Lintlafatso tsa Mekhoa ea Tlhatlhobo e Kenyelletsang Lenaneo la Boithuto ba Botsitso.

Phetisetso ea mahlale ho T&T Scientific Contract Development and Manufacturing Organisation (CDMO) e kenyelletsa boiteko ba ho theha, boleng, le lihlopha tsa mafapha a tlhahiso ho tloha qalong ea li-batches tsa pele tsa bongaka kapa tsa bongaka ka mesebetsi ea khoebo le nako eohle ea bophelo ba sehlahisoa. Nakong ea ts'ebetso ea khetho, re sebetsa haufi-ufi le bareki libakeng tsa bohlokoa tse tla hloka CDMO ho lokisetsa Setatemente sa Mosebetsi (SOW). Ts'ebetso ena e ka ba nakong ea liteko tsa pele tsa kliniki, tsa mohato oa I, oa II, le oa III. Ts'ebetso ea phetisetso ea theknoloji e kenyelletsa ho amohela tlhaiso-leseling eohle e ntlafalitsoeng ho tsoa liphuputsong tsa bareki le liphetho tsa laborateng, tlhahlobo ea kotsi, nts'etsopele ea ts'ebetso ea tlhahiso, mekhoa ea tlhahlobo, le ho nka tlhahisoleseling litlalehong tsa nts'etsopele tse itokisetsang tlhahiso ea kopo ea taolo le Investigational New Drug (IND).

Sehlopheng sa rona sa T&T Scientific, ho bohlokoa hore sehlopha sa phetisetso ea mahlale se kenyelletse litsebi tse sebetsanang le litaba tse fapaneng thutong ea mantlha ea nanoparticles, analytics, technology, regulatory, production, and compliance mafapheng a fapaneng a k'hamphani ea rona. T&T e thehile liboka tsa beke le beke le baemeli ba bareki ho fana ka lintlha mabapi le mesebetsi ea beke e fetileng, lintlafatso, liphephetso, mehopolo le litsela tse eang pele bakeng sa nako e khuts'oane le e telele.

Lipotso Asked hangata

Litšebeletso le cGMP CDMO

Ke Litšebeletso life tseo T&T Scientific e Fanang ka tsona ho Bareki ba eona?

T&T Scientific Services Kenyelletsa Mekhoa ea Preclinical Formulas, Mekhoa ea Tlhahiso le Tlhahlobo ea Tlhahlobo le Mekhoa ea Ntlafatso ka Tsepamiso ho Phekolo ea Liphatsa tsa lefutso, Phano ea Lithethefatsi, le Lihlahisoa tsa Lithethefatsi tsa Nanomedicines.

Na T&T Scientific e fana ka lithuto le liteko tsa tlhahlobo?

Ee, T&T Scientific e fana ka mefuta e mengata ea liteko tsa tlhahlobo le litlhaku, hammoho le nts'etsopele ea mekhoa ea tlhahlobo e nang le bokhoni ba phetisetso ea mahlale.

Tlholisano ea Litheko (Litšenyehelo Kakaretso Tse Amanang le Boemo ba Indasteri):

T&T Scientific e fana ka litheko tse hlolisanoang ka ho fetesisa ka ho fana ka lits'ebetso tse ntlafalitsoeng ka ho fetesisa tsa tsamaiso le tlhahiso. E ipapisitse le Khetho ea Client T&T Scientific Ka mokhoa o Ikhethang le ka Kholiseho e Fana ka Mehaho e 'Meli ea Litšenyehelo ho Bareki ba eona:

  1. Sebopeho sa Litšenyehelo tsa Linako le Lisebelisoa: Sebopeho sa rona sa Litsenyehelo tse Kakaretso le Litheko ke Indasteri e Hlolisanoang ka ho Fetisisa Litheko le Litefiso bakeng sa Nako ea Basebetsi, 'me Thepa e Rekoang e Fetisoa ho Bareki.
  2. Sebopeho sa Litšenyehelo Tse K'episitsoeng tsa Morero: Ho ipapisitsoe le Khetho ea Moreki, Re boetse re Fana ka Litšenyehelo tse Ikemisitsoeng ka Botlalo bakeng sa Morero le Litefo tsa Kemiso ho Thehiloe ho Khetho ea Moreki.

Na T&T e Hlahisa le Mekhoa ea Tlhahlobo ea Phetiso ea Tech e Thehiloe ho Litaelo le Tumellano ea FDA?

Ee. T&T Scientific e hlahisa liphanele tsa tlhahlobo tse felletseng bakeng sa moreki oa eona tse ipapisitseng le litataiso tsa FDA mabapi le Nanomedicines le Gene Therapies, le Vaccines Drug Products.

Na khamphani e fana ka litšebeletso tsa boeletsi?

E, ehlile, bakeng sa ho qala morero le ho ipapisitse le khetho ea moreki oa rona, re amohela ho qala mosebetsi ka boeletsi.

Na T&T Scientific e tšehetsa lithuto tsa liphoofolo le thepa ea tsona?

E, ha ho tluoa tabeng ea tlhahiso, T&T Scientific e ithaopela ho hlahisa lihlahisoa tsa lithethefatsi tse nyane ho isa ho tse kholo (10s of Liters +), ka tatellano ea nako le litšenyehelo tse ngata, ho latela ts'ebetso ea pele ho ea khoebong.

Na T&T Scientific e ts'ehetsa mesebetsi eohle ea taolo ea tlhahiso le mesebetsi ea pampiri e amehang bakeng sa tlhahiso ea IND e tsamaellanang le litataiso tsa FDA?

E, T&T Scientific Support mesebetsi eohle ea pampiri e hlokoang ho tsoa ho CDMO ea rona ho kenyeletsoa Master Batch Records (MBR), Batch Record, Protocols, Processes, Certificates of Analysis (CofA), OOS, NCR, le ho fana ka tlaleho e felletseng ea tsohle ho moreki.

Tsoelo-pele ea Litlhahlobo tsa Tlhahlobo le Teko ea T&T ea Saense e Fana ka Bareki ba Eona?

Mefuta e mengata ea Analytical Assays e Fana le T&T Scientific le balekane ba eona ba lefats'e:

Ke Litharollo life tsa Mekhoa ea Tlhahiso ea T&T eo Scientific e fanang ka eona ho Bareki ba eona?

  1. Ente ea Solvent le Tangential Flow Filtration (TFF)
  2. Homogenization + Solvent Ente
  3. Tangential Flow Filtration (TFF)
  4. Thin Film Hydration (TFH) + Extrusion
  5. Thin Film Hydration (TFH) + Homogenization (Microfluidizer)
  6. Thin Film Hydration (TFH) + Sonication (Tip and Continual)
  7. Homogenization (Microfluidics)
  8. Sonications (Bate, Kamehla, le Keletso)
  9. Tlatsa 'me U Qete

Matla a T&T Scientific ho Tsamaiso ea Morero kapa Litšebeletso tsa bareki ke afe?

  1. Seboka sa Beke le Beke le Bareki Bohle se Reretsoe Bolelele ba Morero
  2. Sehlopha sa rona se inehetse ho koala Kamano le Bareki le Karabelo ea Letsatsi le Letsatsi nakong ea Lihora tse 24 ho Lipotso le Lipotso tsa bareki.
  3. Ho T&T Scientific, re motlotlo ka tlhokomelo ea bareki le tsepamiso eo re fanang ka puisano ea beke le beke ka liboka tsa marang-rang le ho li beha ka nako ea ts'ebetso bakeng sa tlhahiso efe kapa efe. Sehlopha sohle sa morero se tla be se e-ba teng libokeng tseo.
  4. Ho feta moo, re lula re e-na le motho ea letetseng le mookameli oa merero bakeng sa merero ea litšebeletso tsa rona ea nang le kutloisiso e tebileng ea ts'ebetso eohle ho tloha ho tlhahiso ho ea ho Taolo ea Boleng (QC) hammoho le ho lumellana le Tlhokomelo ea Boleng (QA).

Theknoloji

Ke Mahlale afe a Tlhahiso a Fanang ka Thekiso ke T&T Scientific?

T&T Scientific Services Kenyelletsa Mekhoa ea Preclinical Formulas, Mekhoa ea Tlhahiso le Tlhahlobo ea Tlhahlobo le Mekhoa ea Ntlafatso ka Tsepamiso ho Phekolo ea Liphatsa tsa lefutso, Phano ea Lithethefatsi, le Lihlahisoa tsa Lithethefatsi tsa Nanomedicines.

NanoSizer Extrusion Technologies (MINI, STERILE, AUTOs)

  1. NanoSizer FLOW Solvent Technology Platform (BLINK, CHANNEL, GMP)
    • BLINK: Tekanyo e nyane ho tloha ho uL ho isa ho 10s ea milliliters
    • CHANNEL: Tekanyo e Nyenyane ho tloha ho uL ho isa ho 10s ea limililithara E ikemiselitsoeng ka Taolo ea Mocheso le Inline Dilutions
    • GMP (TSOHLE KA NNGWE): Tekanyo e Nyenyane ho isa ho e Kholo e nang le Bokhoni Bohle bo Kenyelelitsoeng, Khomphutha ea Indasteri, le Sethala sa Software
  1. NanoSizer Extrusion Technologies (MINI, STERILE, AUTOs)
    • MINI: Molumo oa Pele oa Lefatše o Kopantsoeng ka Botlalo o Shoeleng oa Liposome Extruder
    • TŠEBELETSO: Sterilized Liposome le Lipid Extruder bakeng sa Likopo tse Hlokang Botsoali, Tse kang Cell Works, Exosomes, Etc.
    • NanoSizer AUTO I: Fully Automated Liposome Extruder Ideal with 1-10mL Batch and Runs sizes
    • NanoSizer AUTO X: Fully Automated Liposome Extruder Ideal with 10mL-200mL Batch and Runs sizes
    • NanoSizer AUTO Plus: Fully Automated Liposome Extruder Ideal with 10mL-200mL Batch and Runs sizes

Ke mohopolo ofe oa Theknoloji ea Ente ea Solvent, NanoSizer FLOW, o e sebelisang ho hlahisa Lihlahisoa tsa Lithethefatsi tsa Nanoparticle?

Litheknoloji tsa T&T Scientific FLOW li sebelisa phallo e moferefere ho kopanya Theknoloji thekenoloji e ntlafalitsoeng le e nang le thepa ea ho etsa lihlahisoa tsa lithethefatsi tsa nanoparticle tse nang le boleng bo holimo, boleng bo phahameng le bo holimo bo tlase.

Tiisetso ea Boleng le Taolo ea Boleng

T&T Scientific E Hlahlobisitsoe Ka Makhetlo a Mahlano ke Bareki ba cGMP 'me e Atlehile Ka Katleho Liphuputso Tsohle tse Maholo le Tse Nyane nakong ea matsatsi a 30 le a 60 a Liphuputso, ka Tatelano. Ho bile le seoelo ho liphuputso tse kholo nakong ea liphuputso tse entsoeng ho T&T Scientific.

Na ho na le lefapha le ikemetseng la Quality Control/Quality Assurance?

Ee, T&T Scientific e na le basebetsi le sistimi ea boleng le lefapha le ikemetseng le tsamaisoang ke mafapha a mang. Hlooho ea Tlhokomelo ea Boleng ho T&T Scientific e ikarabella bakeng sa ho lumellana le ts'ebetso e hlahang ho T&T Scientific; le Hlooho ea Taolo ea Boleng e ikemelang ka boikemelo bakeng sa tlhahlobo ea taolo ea boleng ba lihlahisoa le litlaleho tsa analytics. T&T CDMO Space and Sector at T&T Scientific e arotsoe ka mafapha a mararo a ikemetseng a 1) Manufacturing Operations, 2) Quality Assurance, le 3) Taolo ea Boleng.

Lits'ebetso tsa Tsamaiso ea Boleng tsa T&T Scientific li Ikamahanya le eng?

Lefapha le leng le le leng ke karolo ea ts'ebetso e ikhethileng ea mokhatlo, 'me mokhoa oa ho sheba boleng ke ona oa mantlha ho tsohle tseo re li etsang mona. Ts'ebetso ea T&T ea Boleng e laoloa ke Bukana ea Boleng ea sebaka sa Marang-rang. Sistimi ea Tsamaiso ea Boleng ea T&T Scientific Corporation e nka tataiso ho tsoa ho 21 CFR Karolo ea 820 ea Tsamaiso ea Boleng mme e latela litlhoko tsohle tsa taolo ea FDA GMP ho kenyeletsoa 21 CFR Karolo ea 210, 21 CFR Karolo ea 211, le 21 CFR Karolo ea 11. Khamphani ha e re ha e qheleloe ka thoko ho 21 CFR. Karolo ea 820, 201, 211, 11 ho 7140 Regal Lane, Knoxville, TN 37918.

Maano a Boleng a T&T Scientific ke afe?

  • Theha maikutlo a boleng a khothalletsang takatso ea ho tsoela pele ho ntlafatsa.
  • Netefatsa hore ho latelwa ditlhoko tsohle tse sebetsang tsa taolo.
  • Netefatsa lihlahisoa le litšebeletso tse bolokehileng le tse sebetsang tse khotsofatsang litlhoko tsa bareki.

Na T&T Scientific e na le Sistimi ea Taolo ea Boleng ba Elektronike?

  • E, T&T Scientific E Sebelisa Sistimi e Phahameng ea Taolo ea Boleng ba Elektronike (Qualio) joalo ka Sistimi ea Elektroniki ea Taolo ea Boleng e Laelanang ka Botlalo le Litlhoko tsa FDA.

Na Litšebeletso tsa Litšoaneleho le Litšebeletso tsa netefatso tse Fanoang bakeng sa NanoSizer FLOW Technologies

E, Lefapha la T&T la Boleng ba Saense le fana ka ts'ebetso e felletseng, koetliso, mangolo a nako le nako le lits'ebeletso tsa netefatso bakeng sa mahlale a NanoSizer FLOW.

Ke Ka makhetlo a makae T&T Scientific e hlahlobiloe nakong e fetileng?

T&T Scientific E Alekoa Ka Katleho Ka Makhetlo a Mahlano ke CGMP Bareki ba Meriana ba Banyane ho isa ho ba Baholo 'me e Atlehile Liphuputso Tsohle tse Maholo le Tse Nyane nakong ea matsatsi a 30 le a 60 a Liphuputso, ka Tatelano. Ho bile le seoelo ho liphuputso tse kholo nakong ea liphuputso tse entsoeng ho T&T Scientific

Na T&T Scientific e na le Mananeo a Koetliso ea Basebetsi ba Khethehileng?

T&T Scientific All Under Roof One GMP Manufacturing e Tsepamisitse Maikutlo a Bohlokoa Koetlisong ea Basebetsi le Mananeo a Eona a Thupelo a Hlophisitsoeng, Matrix e Hlalosa, e Koetlisa, 'me e Lekola Likarolo Tsohle ka Hloko.

Na T&T Scientific e Etsa Boithuto bo Bontšang Khafetsa ba ka Hare le ba Boraro?

T&T Scientific e na le litlhahlobo tse etsoang khafetsa ka selemo ka hare ho naha ho netefatsa hore ho latela melaoana ea morao-rao. Liphuputso tsena li etsoa ke lefapha la netefatso ea boleng le ho latela melao.

 

T&T Scientific E Batlisisa Joang Ts'ebetso/Lihlahisoa le Litlaleho tsa ka hare tse sa Lumellaneng?

T&T Scientific E Hlahlobisitsoe Ka Makhetlo a Mahlano ke Bareki ba cGMP 'me e Atlehile Ka Katleho Liphuputso Tsohle tse Maholo le Tse Nyane nakong ea matsatsi a 30 le a 60 a Liphuputso, ka Tatelano. Ho bile le seoelo ho liphuputso tse kholo nakong ea liphuputso tse entsoeng ho T&T Scientific.

Na T&T Scientific, in Regulas Basics, Nchafatsa SOPs, Protocols, and Procedures?

E, Lefapha la T&T la Boleng ba Saense Kopana ka beke le beke, khoeli le khoeli le kotara 'me le lule le lumellana ka linako tsohle.

Na T&T Scientific Quality Management System e Kentsoe tšebetsong le Litloaelo li Fetola Taolo le Traceability e Feletseng?

T&T Scientific E Hlahlobisitsoe Ka Makhetlo a Mahlano ke Bareki ba cGMP 'me e Atlehile Ka Katleho Liphuputso Tsohle tse Maholo le Tse Nyane nakong ea matsatsi a 30 le a 60 a Liphuputso, ka Tatelano. Ho bile le seoelo ho liphuputso tse kholo nakong ea liphuputso tse entsoeng ho T&T Scientific.

Na T&T Scientific e na le Taolo ea Litokomane tse lumellanang, ho Khutlisa le ho Boloka?

T&T Scientific E Hlahlobisitsoe Ka Makhetlo a Mahlano ke Bareki ba cGMP 'me e Atlehile Ka Katleho Liphuputso Tsohle tse Maholo le Tse Nyane nakong ea matsatsi a 30 le a 60 a Liphuputso, ka Tatelano. Ho bile le seoelo ho liphuputso tse kholo nakong ea liphuputso tse entsoeng ho T&T Scientific.

Tlhahiso-Lisebelisoa tse tala / Taolo ea likarolo?

T&T Scientific E Hlahlobisitsoe Ka Makhetlo a Mahlano ke Bareki ba cGMP 'me e Atlehile Ka Katleho Liphuputso Tsohle tse Maholo le Tse Nyane nakong ea matsatsi a 30 le a 60 a Liphuputso, ka Tatelano. Ho bile le seoelo ho liphuputso tse kholo nakong ea liphuputso tse entsoeng ho T&T Scientific.

Litaolo le Mekhoa ea Teko

E ea ntlafatsa.....

Bokhoni le Bokhoni

E ntlafatsa ...

Qala Mona

Tumellano ea rona e Kopanetsoeng ea ho se Hlahise (Boikhethelo)

Ikopanye le Rona ho Qala Mona

Mekhoa ea ho Etsa le ea Phano ea Lithethefatsi
Moralo le Ntlafatso
Phetisetso ea Theknoloji:
Lits'ebetso tsa Mekhoa ea Tlhahlobo
Process difeme
Optimization le Scale Up
Phetisetso ea Theknoloji:
Ntlafatso ea Ts'ebetso ea Tlhahiso

15,000 SQ.FT. TSOHLE TLAS'A Opereishene ea GMP e le 'ngoe

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Li-headphone li ntle haholo, li bobebe haholo 'me boleng ba molumo boa tsoteha.

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Phetoho e potlakileng

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E-ba hlokolosi ho tsona kaha li ka lahleha habonolo 'me tsa oela libakeng tse sa tloaelehang kaha li nyane haholo.

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ETSA HORE U SELEMETSE SELEMO SA RŌNA

Amohela lingoliloeng tsa rona tsa morao-rao beke le beke, litlhahiso, litataiso le tse ling.

Kea leboha!
Pharmaceutical Preclinical le cGMP Technology Transfer and Development (CDMO Services)

Mekhoa ea Tlhahiso le Phanele e Felletseng ea Ts'ebetso ea Ts'ebetso ea Ts'ebetso ea Ts'ebetso ea Ts'ebetso ho tloha Preclinical ho ea ho CGMP Clinical and Commercialization Stages.

Phetisetso ea Theknoloji ea Preclinical le cGMP, Scale Up, Mekhoa ea Tlhahiso le Lintlafatso tsa Mekhoa ea Tlhatlhobo e Kenyelletsang Lenaneo la Boithuto ba Botsitso.

Phetisetso ea mahlale ho T&T Scientific Contract Development and Manufacturing Organisation (CDMO) e kenyelletsa boiteko ba ho theha, boleng, le lihlopha tsa mafapha a tlhahiso ho tloha qalong ea li-batches tsa pele tsa bongaka kapa tsa bongaka ka mesebetsi ea khoebo le nako eohle ea bophelo ba sehlahisoa. Nakong ea ts'ebetso ea khetho, re sebetsa haufi-ufi le bareki libakeng tsa bohlokoa tse tla hloka CDMO ho lokisetsa Setatemente sa Mosebetsi (SOW). Ts'ebetso ena e ka ba nakong ea liteko tsa pele tsa kliniki, tsa mohato oa I, oa II, le oa III. Ts'ebetso ea phetisetso ea theknoloji e kenyelletsa ho amohela tlhaiso-leseling eohle e ntlafalitsoeng ho tsoa liphuputsong tsa bareki le liphetho tsa laborateng, tlhahlobo ea kotsi, nts'etsopele ea ts'ebetso ea tlhahiso, mekhoa ea tlhahlobo, le ho nka tlhahisoleseling litlalehong tsa nts'etsopele tse itokisetsang tlhahiso ea kopo ea taolo le Investigational New Drug (IND).

Sehlopheng sa rona sa T&T Scientific, ho bohlokoa hore sehlopha sa phetisetso ea mahlale se kenyelletse litsebi tse sebetsanang le litaba tse fapaneng thutong ea mantlha ea nanoparticles, analytics, technology, regulatory, production, and compliance mafapheng a fapaneng a k'hamphani ea rona. T&T e thehile liboka tsa beke le beke le baemeli ba bareki ho fana ka lintlha mabapi le mesebetsi ea beke e fetileng, lintlafatso, liphephetso, mehopolo le litsela tse eang pele bakeng sa nako e khuts'oane le e telele.

Lipotso Asked hangata

Litšebeletso le cGMP CDMO

Ke Litšebeletso life tseo T&T Scientific e Fanang ka tsona ho Bareki ba eona?

T&T Scientific Services Kenyelletsa Mekhoa ea Preclinical Formulas, Mekhoa ea Tlhahiso le Tlhahlobo ea Tlhahlobo le Mekhoa ea Ntlafatso ka Tsepamiso ho Phekolo ea Liphatsa tsa lefutso, Phano ea Lithethefatsi, le Lihlahisoa tsa Lithethefatsi tsa Nanomedicines.

Na T&T Scientific e fana ka lithuto le liteko tsa tlhahlobo?

Ee, T&T Scientific e fana ka mefuta e mengata ea liteko tsa tlhahlobo le litlhaku, hammoho le nts'etsopele ea mekhoa ea tlhahlobo e nang le bokhoni ba phetisetso ea mahlale.

Tlholisano ea Litheko (Litšenyehelo Kakaretso Tse Amanang le Boemo ba Indasteri):

T&T Scientific e fana ka litheko tse hlolisanoang ka ho fetesisa ka ho fana ka lits'ebetso tse ntlafalitsoeng ka ho fetesisa tsa tsamaiso le tlhahiso. E ipapisitse le Khetho ea Client T&T Scientific Ka mokhoa o Ikhethang le ka Kholiseho e Fana ka Mehaho e 'Meli ea Litšenyehelo ho Bareki ba eona:

  1. Sebopeho sa Litšenyehelo tsa Linako le Lisebelisoa: Sebopeho sa rona sa Litsenyehelo tse Kakaretso le Litheko ke Indasteri e Hlolisanoang ka ho Fetisisa Litheko le Litefiso bakeng sa Nako ea Basebetsi, 'me Thepa e Rekoang e Fetisoa ho Bareki.
  2. Sebopeho sa Litšenyehelo Tse K'episitsoeng tsa Morero: Ho ipapisitsoe le Khetho ea Moreki, Re boetse re Fana ka Litšenyehelo tse Ikemisitsoeng ka Botlalo bakeng sa Morero le Litefo tsa Kemiso ho Thehiloe ho Khetho ea Moreki.

Na T&T e Hlahisa le Mekhoa ea Tlhahlobo ea Phetiso ea Tech e Thehiloe ho Litaelo le Tumellano ea FDA?

Ee. T&T Scientific e hlahisa liphanele tsa tlhahlobo tse felletseng bakeng sa moreki oa eona tse ipapisitseng le litataiso tsa FDA mabapi le Nanomedicines le Gene Therapies, le Vaccines Drug Products.

Na khamphani e fana ka litšebeletso tsa boeletsi?

E, ehlile, bakeng sa ho qala morero le ho ipapisitse le khetho ea moreki oa rona, re amohela ho qala mosebetsi ka boeletsi.

Na T&T Scientific e tšehetsa lithuto tsa liphoofolo le thepa ea tsona?

E, ha ho tluoa tabeng ea tlhahiso, T&T Scientific e ithaopela ho hlahisa lihlahisoa tsa lithethefatsi tse nyane ho isa ho tse kholo (10s of Liters +), ka tatellano ea nako le litšenyehelo tse ngata, ho latela ts'ebetso ea pele ho ea khoebong.

Na T&T Scientific e ts'ehetsa mesebetsi eohle ea taolo ea tlhahiso le mesebetsi ea pampiri e amehang bakeng sa tlhahiso ea IND e tsamaellanang le litataiso tsa FDA?

E, T&T Scientific Support mesebetsi eohle ea pampiri e hlokoang ho tsoa ho CDMO ea rona ho kenyeletsoa Master Batch Records (MBR), Batch Record, Protocols, Processes, Certificates of Analysis (CofA), OOS, NCR, le ho fana ka tlaleho e felletseng ea tsohle ho moreki.

Tsoelo-pele ea Litlhahlobo tsa Tlhahlobo le Teko ea T&T ea Saense e Fana ka Bareki ba Eona?

Mefuta e mengata ea Analytical Assays e Fana le T&T Scientific le balekane ba eona ba lefats'e:

Ke Litharollo life tsa Mekhoa ea Tlhahiso ea T&T eo Scientific e fanang ka eona ho Bareki ba eona?

  1. Ente ea Solvent le Tangential Flow Filtration (TFF)
  2. Homogenization + Solvent Ente
  3. Tangential Flow Filtration (TFF)
  4. Thin Film Hydration (TFH) + Extrusion
  5. Thin Film Hydration (TFH) + Homogenization (Microfluidizer)
  6. Thin Film Hydration (TFH) + Sonication (Tip and Continual)
  7. Homogenization (Microfluidics)
  8. Sonications (Bate, Kamehla, le Keletso)
  9. Tlatsa 'me U Qete

Matla a T&T Scientific ho Tsamaiso ea Morero kapa Litšebeletso tsa bareki ke afe?

  1. Seboka sa Beke le Beke le Bareki Bohle se Reretsoe Bolelele ba Morero
  2. Sehlopha sa rona se inehetse ho koala Kamano le Bareki le Karabelo ea Letsatsi le Letsatsi nakong ea Lihora tse 24 ho Lipotso le Lipotso tsa bareki.
  3. Ho T&T Scientific, re motlotlo ka tlhokomelo ea bareki le tsepamiso eo re fanang ka puisano ea beke le beke ka liboka tsa marang-rang le ho li beha ka nako ea ts'ebetso bakeng sa tlhahiso efe kapa efe. Sehlopha sohle sa morero se tla be se e-ba teng libokeng tseo.
  4. Ho feta moo, re lula re e-na le motho ea letetseng le mookameli oa merero bakeng sa merero ea litšebeletso tsa rona ea nang le kutloisiso e tebileng ea ts'ebetso eohle ho tloha ho tlhahiso ho ea ho Taolo ea Boleng (QC) hammoho le ho lumellana le Tlhokomelo ea Boleng (QA).

Theknoloji

Ke Mahlale afe a Tlhahiso a Fanang ka Thekiso ke T&T Scientific?

T&T Scientific Services Kenyelletsa Mekhoa ea Preclinical Formulas, Mekhoa ea Tlhahiso le Tlhahlobo ea Tlhahlobo le Mekhoa ea Ntlafatso ka Tsepamiso ho Phekolo ea Liphatsa tsa lefutso, Phano ea Lithethefatsi, le Lihlahisoa tsa Lithethefatsi tsa Nanomedicines.

NanoSizer Extrusion Technologies (MINI, STERILE, AUTOs)

  1. NanoSizer FLOW Solvent Technology Platform (BLINK, CHANNEL, GMP)
    • BLINK: Tekanyo e nyane ho tloha ho uL ho isa ho 10s ea milliliters
    • CHANNEL: Tekanyo e Nyenyane ho tloha ho uL ho isa ho 10s ea limililithara E ikemiselitsoeng ka Taolo ea Mocheso le Inline Dilutions
    • GMP (TSOHLE KA NNGWE): Tekanyo e Nyenyane ho isa ho e Kholo e nang le Bokhoni Bohle bo Kenyelelitsoeng, Khomphutha ea Indasteri, le Sethala sa Software
  1. NanoSizer Extrusion Technologies (MINI, STERILE, AUTOs)
    • MINI: Molumo oa Pele oa Lefatše o Kopantsoeng ka Botlalo o Shoeleng oa Liposome Extruder
    • TŠEBELETSO: Sterilized Liposome le Lipid Extruder bakeng sa Likopo tse Hlokang Botsoali, Tse kang Cell Works, Exosomes, Etc.
    • NanoSizer AUTO I: Fully Automated Liposome Extruder Ideal with 1-10mL Batch and Runs sizes
    • NanoSizer AUTO X: Fully Automated Liposome Extruder Ideal with 10mL-200mL Batch and Runs sizes
    • NanoSizer AUTO Plus: Fully Automated Liposome Extruder Ideal with 10mL-200mL Batch and Runs sizes

Ke mohopolo ofe oa Theknoloji ea Ente ea Solvent, NanoSizer FLOW, o e sebelisang ho hlahisa Lihlahisoa tsa Lithethefatsi tsa Nanoparticle?

Litheknoloji tsa T&T Scientific FLOW li sebelisa phallo e moferefere ho kopanya Theknoloji thekenoloji e ntlafalitsoeng le e nang le thepa ea ho etsa lihlahisoa tsa lithethefatsi tsa nanoparticle tse nang le boleng bo holimo, boleng bo phahameng le bo holimo bo tlase.

Tiisetso ea Boleng le Taolo ea Boleng

T&T Scientific E Hlahlobisitsoe Ka Makhetlo a Mahlano ke Bareki ba cGMP 'me e Atlehile Ka Katleho Liphuputso Tsohle tse Maholo le Tse Nyane nakong ea matsatsi a 30 le a 60 a Liphuputso, ka Tatelano. Ho bile le seoelo ho liphuputso tse kholo nakong ea liphuputso tse entsoeng ho T&T Scientific.

Na ho na le lefapha le ikemetseng la Quality Control/Quality Assurance?

Ee, T&T Scientific e na le basebetsi le sistimi ea boleng le lefapha le ikemetseng le tsamaisoang ke mafapha a mang. Hlooho ea Tlhokomelo ea Boleng ho T&T Scientific e ikarabella bakeng sa ho lumellana le ts'ebetso e hlahang ho T&T Scientific; le Hlooho ea Taolo ea Boleng e ikemelang ka boikemelo bakeng sa tlhahlobo ea taolo ea boleng ba lihlahisoa le litlaleho tsa analytics. T&T CDMO Space and Sector at T&T Scientific e arotsoe ka mafapha a mararo a ikemetseng a 1) Manufacturing Operations, 2) Quality Assurance, le 3) Taolo ea Boleng.

Lits'ebetso tsa Tsamaiso ea Boleng tsa T&T Scientific li Ikamahanya le eng?

Lefapha le leng le le leng ke karolo ea ts'ebetso e ikhethileng ea mokhatlo, 'me mokhoa oa ho sheba boleng ke ona oa mantlha ho tsohle tseo re li etsang mona. Ts'ebetso ea T&T ea Boleng e laoloa ke Bukana ea Boleng ea sebaka sa Marang-rang. Sistimi ea Tsamaiso ea Boleng ea T&T Scientific Corporation e nka tataiso ho tsoa ho 21 CFR Karolo ea 820 ea Tsamaiso ea Boleng mme e latela litlhoko tsohle tsa taolo ea FDA GMP ho kenyeletsoa 21 CFR Karolo ea 210, 21 CFR Karolo ea 211, le 21 CFR Karolo ea 11. Khamphani ha e re ha e qheleloe ka thoko ho 21 CFR. Karolo ea 820, 201, 211, 11 ho 7140 Regal Lane, Knoxville, TN 37918.

Maano a Boleng a T&T Scientific ke afe?

  • Theha maikutlo a boleng a khothalletsang takatso ea ho tsoela pele ho ntlafatsa.
  • Netefatsa hore ho latelwa ditlhoko tsohle tse sebetsang tsa taolo.
  • Netefatsa lihlahisoa le litšebeletso tse bolokehileng le tse sebetsang tse khotsofatsang litlhoko tsa bareki.

Na T&T Scientific e na le Sistimi ea Taolo ea Boleng ba Elektronike?

  • E, T&T Scientific E Sebelisa Sistimi e Phahameng ea Taolo ea Boleng ba Elektronike (Qualio) joalo ka Sistimi ea Elektroniki ea Taolo ea Boleng e Laelanang ka Botlalo le Litlhoko tsa FDA.

Na Litšebeletso tsa Litšoaneleho le Litšebeletso tsa netefatso tse Fanoang bakeng sa NanoSizer FLOW Technologies

E, Lefapha la T&T la Boleng ba Saense le fana ka ts'ebetso e felletseng, koetliso, mangolo a nako le nako le lits'ebeletso tsa netefatso bakeng sa mahlale a NanoSizer FLOW.

Ke Ka makhetlo a makae T&T Scientific e hlahlobiloe nakong e fetileng?

T&T Scientific E Alekoa Ka Katleho Ka Makhetlo a Mahlano ke CGMP Bareki ba Meriana ba Banyane ho isa ho ba Baholo 'me e Atlehile Liphuputso Tsohle tse Maholo le Tse Nyane nakong ea matsatsi a 30 le a 60 a Liphuputso, ka Tatelano. Ho bile le seoelo ho liphuputso tse kholo nakong ea liphuputso tse entsoeng ho T&T Scientific

Na T&T Scientific e na le Mananeo a Koetliso ea Basebetsi ba Khethehileng?

T&T Scientific All Under Roof One GMP Manufacturing e Tsepamisitse Maikutlo a Bohlokoa Koetlisong ea Basebetsi le Mananeo a Eona a Thupelo a Hlophisitsoeng, Matrix e Hlalosa, e Koetlisa, 'me e Lekola Likarolo Tsohle ka Hloko.

Na T&T Scientific e Etsa Boithuto bo Bontšang Khafetsa ba ka Hare le ba Boraro?

T&T Scientific e na le litlhahlobo tse etsoang khafetsa ka selemo ka hare ho naha ho netefatsa hore ho latela melaoana ea morao-rao. Liphuputso tsena li etsoa ke lefapha la netefatso ea boleng le ho latela melao.

 

T&T Scientific E Batlisisa Joang Ts'ebetso/Lihlahisoa le Litlaleho tsa ka hare tse sa Lumellaneng?

T&T Scientific E Hlahlobisitsoe Ka Makhetlo a Mahlano ke Bareki ba cGMP 'me e Atlehile Ka Katleho Liphuputso Tsohle tse Maholo le Tse Nyane nakong ea matsatsi a 30 le a 60 a Liphuputso, ka Tatelano. Ho bile le seoelo ho liphuputso tse kholo nakong ea liphuputso tse entsoeng ho T&T Scientific.

Na T&T Scientific, in Regulas Basics, Nchafatsa SOPs, Protocols, and Procedures?

E, Lefapha la T&T la Boleng ba Saense Kopana ka beke le beke, khoeli le khoeli le kotara 'me le lule le lumellana ka linako tsohle.

Na T&T Scientific Quality Management System e Kentsoe tšebetsong le Litloaelo li Fetola Taolo le Traceability e Feletseng?

T&T Scientific E Hlahlobisitsoe Ka Makhetlo a Mahlano ke Bareki ba cGMP 'me e Atlehile Ka Katleho Liphuputso Tsohle tse Maholo le Tse Nyane nakong ea matsatsi a 30 le a 60 a Liphuputso, ka Tatelano. Ho bile le seoelo ho liphuputso tse kholo nakong ea liphuputso tse entsoeng ho T&T Scientific.

Na T&T Scientific e na le Taolo ea Litokomane tse lumellanang, ho Khutlisa le ho Boloka?

T&T Scientific E Hlahlobisitsoe Ka Makhetlo a Mahlano ke Bareki ba cGMP 'me e Atlehile Ka Katleho Liphuputso Tsohle tse Maholo le Tse Nyane nakong ea matsatsi a 30 le a 60 a Liphuputso, ka Tatelano. Ho bile le seoelo ho liphuputso tse kholo nakong ea liphuputso tse entsoeng ho T&T Scientific.

Tlhahiso-Lisebelisoa tse tala / Taolo ea likarolo?

T&T Scientific E Hlahlobisitsoe Ka Makhetlo a Mahlano ke Bareki ba cGMP 'me e Atlehile Ka Katleho Liphuputso Tsohle tse Maholo le Tse Nyane nakong ea matsatsi a 30 le a 60 a Liphuputso, ka Tatelano. Ho bile le seoelo ho liphuputso tse kholo nakong ea liphuputso tse entsoeng ho T&T Scientific.

Litaolo le Mekhoa ea Teko

E ea ntlafatsa.....

Bokhoni le Bokhoni

E ntlafatsa ...

Qala Mona

Tumellano ea rona e Kopanetsoeng ea ho se Hlahise (Boikhethelo)

Ikopanye le Rona ho Qala Mona

Mekhoa ea ho Etsa le ea Phano ea Lithethefatsi
Moralo le Ntlafatso
Phetisetso ea Theknoloji:
Lits'ebetso tsa Mekhoa ea Tlhahlobo
Process difeme
Optimization le Scale Up
Phetisetso ea Theknoloji:
Ntlafatso ea Ts'ebetso ea Tlhahiso