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Cov khoom kuaj |
Raws li Ch.P. lus |
Raws li FDA cov cai |
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Kev txheeb xyuas ntawm tes |
[1] Suav Pharmacopoeia 2025 Edition,
[2] GB/T 40172-2021 Cov Lus Qhia dav dav rau Kev Tshawb Fawb Txog Kev Tiv Thaiv Kab Mob hauv Mammalian Cells |
[1] ANSI/ATCCASN-0003-2015 Species-Level Identification of Animal Cells los ntawm Mitochondrial Cytochrome c Oxidase Subunit 1 (CO1) DNA Barcodes. |
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Kev kuaj kab mob thiab fungal |
[1] Suav Pharmacopoeia 2025 Edition, Volumn 3,<0234>Kev Npaj thiab Kev Tswj Xyuas Zoo ntawm Tsiaj Cell Matrix rau Kev Tsim Khoom Siv Tshuaj lom neeg.
[2] Suav Pharmacopoeia 2025 Edition, Volumn 3,<1101>Sterility Test Methods
[3] National Institutes for Food and Drug Control. Cov txheej txheem kev khiav hauj lwm rau kev tshuaj xyuas tshuaj nyob rau hauv Suav teb, 2019 tsab: Sterility Test Method. |
[1] ICH Q5D Derivation thiab Characterization ntawm Cell SubstratesSiv rau Kev Tsim Khoom Siv Hluav Taws Xob / Tshuaj lom neeg (Lub Xya Hli 1997)
[2] Teb Chaws Asmeskas Pharmacopoeia (USP), General Tests thiab Assays:<71>Tsis muaj menyuam
[3] European Pharmacopeia (Ph. Eur.), Tshooj 2.6.1. Tsis muaj menyuam |
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Mycobacterium test |
[1] Suav Pharmacopoeia 2025 Edition, Volumn 3,<0234>Kev Npaj thiab Kev Tswj Xyuas Zoo ntawm Tsiaj Cell Matrix rau Kev Tsim Khoom Siv Tshuaj lom neeg.
[2] Suav Pharmacopoeia 2025 Edition, Volumn 3,<1101>Sterility Test Methods
[3] National Institutes for Food and Drug Control. Cov txheej txheem kev khiav hauj lwm rau kev tshuaj xyuas tshuaj nyob rau hauv Suav teb, 2019 tsab: Sterility Test Method. |
[1] European Pharmacopeia (Ph. Eur.), Ntu 2.6.2 MYCOBACTERIA |
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Kev kuaj Mycoplasma |
[1] Suav Pharmacopoeia 2025 Edition, Volumn 3,<0234>Kev Npaj thiab Kev Tswj Xyuas Zoo ntawm Tsiaj Cell Matrix rau Kev Tsim Khoom Siv Tshuaj lom neeg.
[2] Suav Pharmacopoeia 2025 Edition, Volumn 3<3301>Txoj Kev Xeem Mycoplasma. |
[1] ICH Q5D: Derivation thiab Characterization ntawm Cell SubstratesSiv rau Kev Tsim Khoom Siv Khoom Siv Hluav Taws Xob / Cov Khoom Siv Tshuaj lom neeg (Lub Xya Hli 1997)
[2] Teb Chaws Asmeskas Pharmacopoeia (USP), General Tests thiab Assays:<63 > Mycoplasma Tests
[3] European Pharmacopeia (Ph. Eur.), Ntu 2.6.7 Mycoplasmas |
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Kev kuaj pom ntawm endogenous thiab exogenous viral yam - cell morphology soj ntsuam thiab kuaj ntshav adsorption |
[1] Suav Pharmacopoeia 2020 Edition, Volumn 3 Kev Npaj thiab Kev Tswj Xyuas Zoo ntawm Tsiaj Cell Matrix rau Kev Tsim Khoom thiab Kev Ntsuas Cov Khoom Siv Tshuaj lom neeg. |
NA |
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Kev kuaj pom ntawm endogenous thiab exogenous viral yam - hauv vitro inoculation kab lis kev cai txoj kev siv cov cim qhia sib txawv |
[1] Suav Pharmacopoeia 2025 Edition, Volumn 3<0234>Kev Npaj thiab Kev Tswj Xyuas Zoo ntawm Tsiaj Cell Matrix rau Kev Tsim Khoom Siv Tshuaj lom neeg.
[2] Suav Pharmacopoeia 2025 Edition, Volumn 3<3302>Exogenous Viral Agent Test Method |
[1] Teb Chaws Asmeskas Pharmacopoeia (USP), General Tests thiab Assays:<1237>Virology Test Methods [2] ICH Q5A(R1) Viral Safety Evaluation of Biotechnology ProductsDrived From Cell Lines of Tib Neeg lossis Tsiaj Keeb Kwm (September 1999) [3] European Pharmacopeia (Ph. Eur.), Tshooj 2.6.16. Kev sim rau cov neeg ua hauj lwm extraneous hauv cov tshuaj tiv thaiv kab mob rau tib neeg siv |
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Endogenous thiab exogenous viral factor detection - hauv vivo tsiaj inoculation method |
[1] Suav Pharmacopoeia 2025 Edition, Volumn 3<0234>Kev Npaj thiab Kev Tswj Xyuas Zoo ntawm Tsiaj Cell Matrix rau Kev Tsim Khoom Siv Tshuaj lom neeg.
[2] Suav Pharmacopoeia 2025 Edition, Volumn 3<3302>Exogenous Viral Agent Test Method |
[1] Teb Chaws Asmeskas Pharmacopoeia (USP), General Tests thiab Assays:<1237>Virology Test Methods
[2] ICH Q5A(R1) Viral Safety Evaluation of Biotechnology ProductsDrived From Cell Lines of Tib Neeg lossis Tsiaj Keeb Kwm (September 1999)
[3] European Pharmacopoeia 5.2.3 Cell substrates rau kev tsim cov tshuaj tiv thaiv rau tib neeg siv |
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Endogenous thiab exogenous viral factor testing - retrovirus testing |
[1] Suav Pharmacopoeia 2025 Edition, Volumn 3<0234>Kev Npaj thiab Kev Tswj Xyuas Zoo ntawm Tsiaj Cell Matrix rau Kev Tsim Khoom Siv Tshuaj lom neeg. |
[1] Teb Chaws Asmeskas Pharmacopoeia (USP), General Tests thiab Assays:<1237>Virology Test Methods
[2] ICH Q5A(R1) Viral Safety Evaluation of Biotechnology ProductsDrived From Cell Lines of Tib Neeg lossis Tsiaj Keeb Kwm (September 1999)
[3] European Pharmacopeia (Ph. Eur.), Tshooj 2.6.16. Kev sim rau cov neeg ua hauj lwm extraneous hauv cov tshuaj tiv thaiv kab mob rau tib neeg siv |
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Endogenous thiab exogenous viral factor testing - hom -cov kab mob tshwj xeeb |
[1] Suav Pharmacopoeia 2025 Edition, Volumn 3<0234>Kev Npaj thiab Kev Tswj Xyuas Zoo ntawm Tsiaj Cell Matrix rau Kev Tsim Khoom Siv Tshuaj lom neeg. [2] Suav Pharmacopoeia 2025 Edition, Volumn 3<3303>Test Methods rau Murine Viruses. |
[1] ICH Q5A(R1) Viral Safety Evaluation of Biotechnology ProductsDrived From Cell Lines of Tib Neeg lossis Tsiaj Keeb Kwm (September 1999) [2] FDA Cov ntsiab lus los xav txog hauv Kev Tsim Khoom thiab Kev Ntsuas Cov Khoom Siv Monoclonal Antibody Rau Tib Neeg Siv (Lub Ob Hlis 1997) |
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Endogenous thiab exogenous viral factor testing - bovine - muab tau tus kab mob kuaj |
[1] Suav Pharmacopoeia 2025 Edition, Volumn 3<0234>Kev Npaj thiab Kev Tswj Xyuas Zoo ntawm Tsiaj Cell Matrix rau Kev Tsim Khoom Siv Tshuaj lom neeg.
[2] Suav Pharmacopoeia 2025 Edition, Volumn 3<3604>Newborn Bovine Serum |
[1] Teb Chaws Asmeskas Pharmacopoeia (USP), General Tests thiab Assays:<1237>Virology Test Methods
[2] ICH Q5A(R1) Viral Safety Evaluation of Biotechnology ProductsDrived From Cell Lines of Tib Neeg lossis Tsiaj Keeb Kwm (September 1999)
[3] European Pharmacopeia (Ph. Eur.), Tshooj 2.6.16. Kev sim rau cov neeg ua hauj lwm extraneous hauv cov tshuaj tiv thaiv kab mob rau tib neeg siv
[4] Txoj Cai ntawm Tsoom Fwv Teb Chaws Txoj Cai Title 9 Tsiaj thiab Tsiaj Khoom - Ntu 113 |
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Endogenous thiab exogenous viral factor testing - porcine virus testing |
[1] Suav Pharmacopoeia 2025 Edition, Volumn 3<0234>Kev Npaj thiab Kev Tswj Xyuas Zoo ntawm Tsiaj Cell Matrix rau Kev Tsim Khoom Siv Tshuaj lom neeg. |
[1] Teb Chaws Asmeskas Pharmacopoeia (USP), General Tests thiab Assays:<1237>Virology Test Methods
[2] ICH Q5A(R1) Viral Safety Evaluation of Biotechnology ProductsDrived From Cell Lines of Tib Neeg lossis Tsiaj Keeb Kwm (September 1999)
[3] European Pharmacopeia (Ph. Eur.), Tshooj 2.6.16. Kev sim rau cov neeg ua hauj lwm extraneous hauv cov tshuaj tiv thaiv kab mob rau tib neeg siv
[4] Txoj Cai ntawm Tsoom Fwv Teb Chaws Txoj Cai Title 9 Tsiaj thiab Tsiaj Khoom - Ntu 113 |
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Virus inactivation/removal process validation |
[1] Suav Pharmacopoeia 2025 Edition, Volumn 3<0238>Kab mob kev nyab xeeb ntawm cov khoom siv roj ntsha |
[1] ICH Q5A(R2), Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin (2024) |
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Replicating tus kab mob no |
[1] State Food and Drug Administration. Cov Lus Qhia Txog Kev Siv Tshuaj Hauv Vitro Gene-Kev Tshawb Fawb Kev Tshawb Fawb thiab Kev Ntsuam Xyuas Kev Kho Mob (Tsim Kev Siv)
[2] National Medical Products Administration. "Cov teeb meem tshwm sim thiab cov kev xav tau tshwj xeeb rau kev kuaj pom tus kab mob Lentiviral Replicable" |
[1] FDA. Chemistry, Manufacturing, thiab Control (CMC) Cov Ntaub Ntawv rau Tib Neeg Gene Therapy Investigational New Drug Applications (INDs) Cov Lus Qhia rau Kev Lag Luam
[2] Cov ntaub ntawv luv luv - Kev Ntsuas rau Kev Tshaj Lij Tshaj Lij Tshaj Lij Tshaj Lij Tshaj Lij (RCR) / Lentivirus (RCL) hauv Retroviral thiab Lentiviral Vector Based Gene Therapy Products - Revisiting Tam sim no FDA Cov Lus Pom Zoo
[3] 5. European Medicines Agency (EMEA) thiab Pawg Neeg Saib Xyuas Kev Kho Mob rau Tib Neeg Siv (CHMP). Cov lus qhia txog kev txhim kho thiab tsim cov kab mob lentiviral (EMEA/CHMP/BWP/2458/03) |
