cGMP Manufacturing bakeng sa
Lihlahisoa tsa Lithethefatsi tsa Kliniki le Khoebo
uL ho isa ho 300L+ Batch Size le Scales bakeng sa
Mokhahlelo oa I, Mokhahlelo oa Bobeli, Mokhahlelo oa III, le Meriana ea Khoebo le ea Motho ka Botho
E lumellana le litlhoko tsohle tsa taolo tsa FDA GMP ho kenyelletsa 21 CFR Karolo ea 210, 21 CFR Karolo ea 211, le 21 CFR Karolo ea 11
Pharmaceutical Contract Manufacturer FDA ngoliso # 3015266446

cGMP Manufacturing bakeng sa
Lihlahisoa tsa Lithethefatsi tsa Kliniki le Khoebo

uL ho isa ho 300L+ Batch Size le Scales bakeng sa
Mokhahlelo oa I, Mokhahlelo oa Bobeli, Mokhahlelo oa III, le Meriana ea Khoebo le ea Motho ka Botho
E lumellana le litlhoko tsohle tsa taolo tsa FDA GMP ho kenyelletsa 21 CFR Karolo ea 210, 21 CFR Karolo ea 211, le 21 CFR Karolo ea 11
Pharmaceutical Contract Manufacturer FDA ngoliso # 3015266446
cGMP Pharmaceutical Manufacturing for Clinical and Commercial Batches ea Nanoparticle-based Drug Products, le Complex Injectables (CDMO Services)
Nts'etsopele ea Meriana e Reriloeng le Tlhahiso ea Mokhahlelo oa I/II/III le Likhampani tsa Khoebo tsa Novel le Generic Nanoparticle le Lithethefatsi tse Injectable tse nang le Bokhabane le Boitsebi ho Lihlahisoa tsa Lithethefatsi tsa Nanoparticle tse kang Lipid Nanoparticles (LNPs), Polymer Nanoparticles (PNP), le Hybrid Nanoparticles e nang le mRNA. , RNA, Limolek'hule tse Nyenyane, joalo-joalo.

Ntlafatso ea cGMP le Tlhahiso ea Liente tsa Tleliniki le tsa Khoebo

Re sebeletsa liindasteri tsa lefats'e tsa meriana le biotechnology ho T&T Scientific Contract Development and Production Organisations (CDMO), re fana le ho ts'ehetsa lits'ebeletso tse felletseng tsa GMP tse hlokahalang bakeng sa nts'etsopele, tlhahiso ea bongaka le khoebo ea li-nanomedicine tsa meriana ho tloha qalong ho fihlela qetellong:

1) Tlhahiso e sa Hlakoeng ea Litlhare tsa Litlhare tsa Nanoparticle Pharmaceutical Drug Products
2) Lihlopha tse Nyenyane: UL's ho ea ho mL's Batch Sizes (ke hore, Personalized Medicine)
3) Boemo bo Bohareng: 10mL-20L (ke hore Clinical Phase I/II/III Gene Therapies)  
4) Boholo bo boholo: 20-1000L + (Mokhahlelo oa III le Tlhahiso ea Khoebo
5) Metsoako e Koaheletsoeng ea Meetso: PEGylated, Nucleic Acids (mRNA, siRNA, DNA, saRNA), Liprotheine, Lipids,
6) Mananeo a botsitso ho pholletsa le Khoebo
7) Mekhoa e Felletseng ea Tlhahlobo ea Tlhahlobo le Tlhahlobo ea Taolo ea Boleng  
8) Tsamaiso ea Morero le Liboka tsa Beke le Beke
9) Tiisetso ea Boleng, Taolo ea Likotsi le Tumellano
10) Li-filters tse nyopa
11) Ho Tlatsa, Qetella, le ho Ngola ka Nōka
12) Ketane ea Phepelo le Tsamaiso ea Lintho tse Raw
13) Botšepehi ba ho koala setshelo

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 Tlhahlobo ea Taolo ea Boleng le Tsoelo-pele ea Tlhahlobo
  • Morphology ea liposomes, ho kenyelletsa le boikemisetso ba lamellarity Litšobotsi tsa bokaholimo ba liposomes, joalo ka ha li sebetsa, mohlala, pegylation. 
    Sekhahla sa boholo Ho se tsotelle
    Chelete ea chelete, le menyetla ea Zeta Tšebeliso ea Lithethefatsi le Bohloeki
    Sekahare sa Solvent se setseng   Phetoho ea Mocheso
    Quantification of In Vitro Release of the Drug Substance Leakage Rate of Drug Ingredients (API) ho tsoa ho Liposomes le Lipid Nanoparticles Ho pholletsa le Shelf Life
    Leakage Rate of Drug Ingredients (API) ho tsoa ho Liposomes le Lipid Nanoparticles Ho pholletsa le Shelf Life Encapsulation Efficiency Assays bakeng sa li-API tse kang Plasmid DNA, mRNA, siRNA, Antibodies, joalo-joalo. 
Tsepamiso ea Mekhoa ea Tlhahiso
    • Lyophilization
    • Thin Film Hydration (TFH)
    • Ente ea Solvent
    • Phallo e Phahameng ea Khatello
    • Ho kopanya Microfluidics
    • Homogenization ea Khatello e Phahameng
    • Tangential Flow Filtrations
    Sonication (Tip, Bath, Continuous)
    • Ho kopanya Microfluidics
    • Sonication (Tip, Bath, Continuous)
    Ts'ebetso e Hloekileng le ho Etsa Tlatsa 'me U Qete
Boholo ba Batch le Bokhoni

Lihlopha tse Nyenyane: UL's to mL's Batch Sizes (ke hore, Personalized Medicine) ka mL Boemo bo Bohareng: 10mL-20L (ke hore Clinical Phase I/II/III Gene Therapies)
Sekhahla se Seholo: 20-1000L+ (Mokhahlelo oa III le Tlhahiso ea Khoebo)

Tsepamiso ea Boipheliso le Liphihlelo
Lipid Nanoparticle (LNP) le Lihlahisoa tsa Lithethefatsi tsa Liposomal
Polymeric Nanoparticle (PNP) Lihlahisoa tsa Lithethefatsi tsa Lithethefatsi
Mekhoa ea Pegylated
  • Polymeric+Lipids (Hybrid Nanoparticles)
  • Nucleic Acids: mRNA, siRNA, DNA, saRNA, tRNA le rRNA
  • Meetso ea PEGylated (Liposomal, Lipid-based, Polymeric, le Hybrids
Mekhoa ea Tlhahlobo ea Taolo ea Boleng le Tsoelo-pele ea Tlhahlobo
  • Morphology ea liposomes, ho kenyelletsa le boikemisetso ba lamellarity Litšobotsi tsa bokaholimo ba liposomes, joalo ka ha li sebetsa, mohlala, pegylation. 
    Sekhahla sa boholo Ho se tsotelle
    Chelete ea chelete, le menyetla ea Zeta Tšebeliso ea Lithethefatsi le Bohloeki
    Sekahare sa Solvent se setseng   Phetoho ea Mocheso
    Quantification of In Vitro Release of the Drug Substance Leakage Rate of Drug Ingredients (API) ho tsoa ho Liposomes le Lipid Nanoparticles Ho pholletsa le Shelf Life
    Leakage Rate of Drug Ingredients (API) ho tsoa ho Liposomes le Lipid Nanoparticles Ho pholletsa le Shelf Life Encapsulation Efficiency Assays bakeng sa li-API tse kang Plasmid DNA, mRNA, siRNA, Antibodies, joalo-joalo. 

Re sebeletsa liindasteri tsa lefats'e tsa meriana le biotechnology ho T&T Scientific Contract Development and Production Organisations (CDMO), re fana le ho ts'ehetsa lits'ebeletso tse felletseng tsa GMP tse hlokahalang bakeng sa nts'etsopele, tlhahiso ea bongaka le khoebo ea li-nanomedicine tsa meriana ho tloha qalong ho fihlela qetellong:

1) Tlhahiso e sa Hlakoeng ea Litlhare tsa Litlhare tsa Nanoparticle Pharmaceutical Drug Products
2) Lihlopha tse Nyenyane: UL's ho ea ho mL's Batch Sizes (ke hore, Personalized Medicine)
3) Boemo bo Bohareng: 10mL-20L (ke hore Clinical Phase I/II/III Gene Therapies)  
4) Boholo bo boholo: 20-1000L + (Mokhahlelo oa III le Tlhahiso ea Khoebo
5) Metsoako e Koaheletsoeng ea Meetso: PEGylated, Nucleic Acids (mRNA, siRNA, DNA, saRNA), Liprotheine, Lipids,
6) Mananeo a botsitso ho pholletsa le Khoebo
7) Mekhoa e Felletseng ea Tlhahlobo ea Tlhahlobo le Tlhahlobo ea Taolo ea Boleng  
8) Tsamaiso ea Morero le Liboka tsa Beke le Beke
9) Tiisetso ea Boleng, Taolo ea Likotsi le Tumellano
10) Li-filters tse nyopa
11) Ho Tlatsa, Qetella, le ho Ngola ka Nōka
12) Ketane ea Phepelo le Tsamaiso ea Lintho tse Raw
13) Botšepehi ba ho koala setshelo

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 Tlhahlobo ea Taolo ea Boleng le Tsoelo-pele ea Tlhahlobo
  • Morphology ea liposomes, ho kenyelletsa le boikemisetso ba lamellarity Litšobotsi tsa bokaholimo ba liposomes, joalo ka ha li sebetsa, mohlala, pegylation. 
    Sekhahla sa boholo Ho se tsotelle
    Chelete ea chelete, le menyetla ea Zeta Tšebeliso ea Lithethefatsi le Bohloeki
    Sekahare sa Solvent se setseng   Phetoho ea Mocheso
    Quantification of In Vitro Release of the Drug Substance Leakage Rate of Drug Ingredients (API) ho tsoa ho Liposomes le Lipid Nanoparticles Ho pholletsa le Shelf Life
    Leakage Rate of Drug Ingredients (API) ho tsoa ho Liposomes le Lipid Nanoparticles Ho pholletsa le Shelf Life Encapsulation Efficiency Assays bakeng sa li-API tse kang Plasmid DNA, mRNA, siRNA, Antibodies, joalo-joalo. 
Tsepamiso ea Mekhoa ea Tlhahiso
    • Lyophilization
    • Thin Film Hydration (TFH)
    • Ente ea Solvent
    • Phallo e Phahameng ea Khatello
    • Ho kopanya Microfluidics
    • Homogenization ea Khatello e Phahameng
    • Tangential Flow Filtrations
    Sonication (Tip, Bath, Continuous)
    • Ho kopanya Microfluidics
    • Sonication (Tip, Bath, Continuous)
    Ts'ebetso e Hloekileng le ho Etsa Tlatsa 'me U Qete
Boholo ba Batch le Bokhoni

Lihlopha tse Nyenyane: UL's to mL's Batch Sizes (ke hore, Personalized Medicine) ka mL Boemo bo Bohareng: 10mL-20L (ke hore Clinical Phase I/II/III Gene Therapies)
Sekhahla se Seholo: 20-1000L+ (Mokhahlelo oa III le Tlhahiso ea Khoebo)

Tsepamiso ea Boipheliso le Liphihlelo
Lipid Nanoparticle (LNP) le Lihlahisoa tsa Lithethefatsi tsa Liposomal
Polymeric Nanoparticle (PNP) Lihlahisoa tsa Lithethefatsi tsa Lithethefatsi
Mekhoa ea Pegylated
  • Polymeric+Lipids (Hybrid Nanoparticles)
  • Nucleic Acids: mRNA, siRNA, DNA, saRNA, tRNA le rRNA
  • Meetso ea PEGylated (Liposomal, Lipid-based, Polymeric, le Hybrids
Mekhoa ea Tlhahlobo ea Taolo ea Boleng le Tsoelo-pele ea Tlhahlobo
  • Morphology ea liposomes, ho kenyelletsa le boikemisetso ba lamellarity Litšobotsi tsa bokaholimo ba liposomes, joalo ka ha li sebetsa, mohlala, pegylation. 
    Sekhahla sa boholo Ho se tsotelle
    Chelete ea chelete, le menyetla ea Zeta Tšebeliso ea Lithethefatsi le Bohloeki
    Sekahare sa Solvent se setseng   Phetoho ea Mocheso
    Quantification of In Vitro Release of the Drug Substance Leakage Rate of Drug Ingredients (API) ho tsoa ho Liposomes le Lipid Nanoparticles Ho pholletsa le Shelf Life
    Leakage Rate of Drug Ingredients (API) ho tsoa ho Liposomes le Lipid Nanoparticles Ho pholletsa le Shelf Life Encapsulation Efficiency Assays bakeng sa li-API tse kang Plasmid DNA, mRNA, siRNA, Antibodies, joalo-joalo. 

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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Sehlahisoa se setle sa apole bakeng sa theko ea tlholisano haholo. Ho odara marang-rang ho ne ho se bonolo, 'me ke khonne ho bokella nakong ea matsatsi a 2 ka mor'a ho kenya odara ea ka.

- Luke Johnson

Ba rate

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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