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Testing items |
According to Ch.P. clause |
According to FDA regulations |
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Cell identification |
[1] Chinese Pharmacopoeia 2025 Edition,
[2] GB/T 40172-2021 General Guidelines for the Detection of Cross-Contamination in Mammalian Cells |
[1] ANSI/ATCCASN-0003-2015 Species-Level Identification of Animal Cells through Mitochondrial Cytochrome c Oxidase Subunit 1 (CO1) DNA Barcodes. |
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Bacterial and fungal examination |
[1] Chinese Pharmacopoeia 2025 Edition, Volumn 3, <0234>Preparation and Quality Control of Animal Cell Matrix for the Manufacturing of Biological Products.
[2] Chinese Pharmacopoeia 2025 Edition, Volumn 3, <1101>Sterility Test Methods
[3] National Institutes for Food and Drug Control. Standard Operating Procedures for Drug Inspection in China, 2019 Edition: Sterility Testing Method. |
[1] ICH Q5D Derivation and Characterization of Cell SubstratesUsed For Production of Biotechnological/Biological Products (July1997)
[2] United States Pharmacopoeia (USP), General Tests and Assays:<71> Sterility
[3] European Pharmacopeia (Ph. Eur.), Section 2.6.1. Sterility |
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Mycobacterium test |
[1] Chinese Pharmacopoeia 2025 Edition, Volumn 3, <0234>Preparation and Quality Control of Animal Cell Matrix for the Manufacturing of Biological Products.
[2] Chinese Pharmacopoeia 2025 Edition, Volumn 3, <1101> Sterility Test Methods
[3] National Institutes for Food and Drug Control. Standard Operating Procedures for Drug Inspection in China, 2019 Edition: Sterility Testing Method. |
[1] European Pharmacopeia (Ph. Eur.), Section 2.6.2 MYCOBACTERIA |
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Mycoplasma test |
[1] Chinese Pharmacopoeia 2025 Edition, Volumn 3, <0234>Preparation and Quality Control of Animal Cell Matrix for the Manufacturing of Biological Products.
[2] Chinese Pharmacopoeia 2025 Edition, Volumn 3 <3301> Mycoplasma Examination Method. |
[1] ICH Q5D: Derivation and Characterization of Cell SubstratesUsed For Production of Biotechnological/Biological Products (July1997)
[2] United States Pharmacopoeia (USP), General Tests and Assays:<63 > Mycoplasma Tests
[3] European Pharmacopeia (Ph. Eur.), Section 2.6.7 Mycoplasmas |
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Detection of endogenous and exogenous viral factors - cell morphology observation and blood adsorption test |
[1] Chinese Pharmacopoeia 2020 Edition, Volumn 3 Preparation and Quality Control of Animal Cell Matrix for the Manufacturing and Testing of Biological Products. |
NA |
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Detection of endogenous and exogenous viral factors - in vitro inoculation culture method using different indicator cells |
[1] Chinese Pharmacopoeia 2025 Edition, Volumn 3 <0234>Preparation and Quality Control of Animal Cell Matrix for the Manufacturing of Biological Products.
[2] Chinese Pharmacopoeia 2025 Edition, Volumn 3 <3302> Exogenous Viral Agent Test Method |
[1] United States Pharmacopoeia (USP), General Tests and Assays:<1237> Virology Test Methods [2] ICH Q5A(R1) Viral Safety Evaluation of Biotechnology ProductsDerived From Cell Lines of Human or Animal Origin (September1999) [3] European Pharmacopeia (Ph. Eur.), Section 2.6.16. Tests for extraneous agents in viral vaccines for human use |
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Endogenous and exogenous viral factor detection - in vivo animal inoculation method |
[1] Chinese Pharmacopoeia 2025 Edition, Volumn 3 <0234>Preparation and Quality Control of Animal Cell Matrix for the Manufacturing of Biological Products.
[2] Chinese Pharmacopoeia 2025 Edition, Volumn 3 <3302> Exogenous Viral Agent Test Method |
[1] United States Pharmacopoeia (USP), General Tests and Assays:<1237> Virology Test Methods
[2] ICH Q5A(R1) Viral Safety Evaluation of Biotechnology ProductsDerived From Cell Lines of Human or Animal Origin (September1999)
[3] European Pharmacopoeia 5.2.3 Cell substrates for production of vaccines for human use |
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Endogenous and exogenous viral factor testing - retrovirus testing |
[1] Chinese Pharmacopoeia 2025 Edition, Volumn 3 <0234>Preparation and Quality Control of Animal Cell Matrix for the Manufacturing of Biological Products. |
[1] United States Pharmacopoeia (USP), General Tests and Assays:<1237> Virology Test Methods
[2] ICH Q5A(R1) Viral Safety Evaluation of Biotechnology ProductsDerived From Cell Lines of Human or Animal Origin (September1999)
[3] European Pharmacopeia (Ph. Eur.), Section 2.6.16. Tests for extraneous agents in viral vaccines for human use |
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Endogenous and exogenous viral factor testing - species-specific virus testing |
[1] Chinese Pharmacopoeia 2025 Edition, Volumn 3 <0234>Preparation and Quality Control of Animal Cell Matrix for the Manufacturing of Biological Products. [2] Chinese Pharmacopoeia 2025 Edition, Volumn 3 <3303> Test Methods for Murine Viruses. |
[1] ICH Q5A(R1) Viral Safety Evaluation of Biotechnology ProductsDerived From Cell Lines of Human or Animal Origin (September1999) [2] FDA Points to Consider in the Manufacture and Testing ofMonoclonal Antibody Products For Human Use (February 1997) |
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Endogenous and exogenous viral factor testing - bovine-derived virus testing |
[1] Chinese Pharmacopoeia 2025 Edition, Volumn 3 <0234>Preparation and Quality Control of Animal Cell Matrix for the Manufacturing of Biological Products.
[2] Chinese Pharmacopoeia 2025 Edition, Volumn 3 <3604> Newborn Bovine Serum |
[1] United States Pharmacopoeia (USP), General Tests and Assays:<1237> Virology Test Methods
[2] ICH Q5A(R1) Viral Safety Evaluation of Biotechnology ProductsDerived From Cell Lines of Human or Animal Origin (September1999)
[3] European Pharmacopeia (Ph. Eur.), Section 2.6.16. Tests for extraneous agents in viral vaccines for human use
[4] Code of Federal Regulations Title 9 Animals and AnimalProducts – Part 113 |
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Endogenous and exogenous viral factor testing - porcine virus testing |
[1] Chinese Pharmacopoeia 2025 Edition, Volumn 3 <0234>Preparation and Quality Control of Animal Cell Matrix for the Manufacturing of Biological Products. |
[1] United States Pharmacopoeia (USP), General Tests and Assays:<1237> Virology Test Methods
[2] ICH Q5A(R1) Viral Safety Evaluation of Biotechnology ProductsDerived From Cell Lines of Human or Animal Origin (September1999)
[3] European Pharmacopeia (Ph. Eur.), Section 2.6.16. Tests for extraneous agents in viral vaccines for human use
[4] Code of Federal Regulations Title 9 Animals and AnimalProducts – Part 113 |
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Virus inactivation/removal process validation |
[1] Chinese Pharmacopoeia 2025 Edition, Volumn 3 <0238> Virus Safety Control of Biological Products |
[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 virus detection |
[1] State Food and Drug Administration. Technical Guidelines for In Vitro Gene-Modified Systemic Pharmaceutical Research and Evaluation (Trial Implementation)
[2] National Medical Products Administration. "Common Problems and Technical Requirements for the Detection of Replicable Lentiviral Viruses" |
[1] FDA. Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) Guidance for Industry
[2] Briefing Document - Testing for Replication Competent Retrovirus (RCR)/Lentivirus (RCL) in Retroviral and Lentiviral Vector Based Gene Therapy Products - Revisiting Current FDA Recommendations
[3] 5. European Medicines Agency (EMEA) and the Committee for Medicinal Products for Human Use (CHMP). Guidelines on development and manufacture of lentiviral vectors (EMEA/CHMP/BWP/2458/03) |
