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The Chinese Pharmacopoeia requires cell line characterization, and various regulatory documents from NMPA, FDA, EMA, WHO, and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) outline requirements and guidelines for cell bank characterization, which aim to confirm the origin and history of cells and to identify and test their identity, stability, and purity.
Cell characterization primarily includes the following aspects: cell identification, sterility testing, mycoplasma testing, endogenous and exogenous viral agent testing, tumorigenicity/oncogenicity testing, etc.
These testing items apply to Master Cell Banks (MCB), Working Cell Banks (WCB), and production limited passage cells.
We recommend conducting characterization tests on both mammalian and non-mammalian cell lines at various stages of drug production, including:
Master Cell Bank (MCB), Working Cell Bank (WCB), End-of-Production Cells (EOPC), Virus Seed Stock (VSS), raw materials and final products.
细胞系检测
Cell Identification Test
Newly established cell lines, cell banks, and end-of-production cells should undergo identification tests to confirm their authenticity and rule out cross-contamination with other cells. Canvest Bio provides a variety of identification tests, allowing customers to select one or more methods for species/variation identification of their cell lines.
Chromosomal Karyotype Analysis
Karyotype analysis helps confirm the identity of the cell line and its species of origin. We have extensive experience in karyotype analysis of various cell types, including human cells, human stem cells, monkey Vero cells, and hamster CHO cells.
Chromosomal karyotype analysis includes but is not limited to: G-banding analysis of metaphase chromosomes, Chromosome counting (providing diploid chromosome numbers, frequency distribution, and polyploidy levels).
Isoenzyme Testing
Isoenzyme testing involves gel electrophoresis analysis of three key enzymes: lactate dehydrogenase (LD), glucose-6-phosphate dehydrogenase (G6PD), nucleoside phosphorylase (NP). By comparing the enzyme profiles with reference cells, potential cross-contamination can be accessed.
Short Tandem Repeat (STR) Analysis
STR analysis is performed by extracting DNA from the sample, amplifying STR loci via PCR, detecting the PCR products, and analyzing the results. The obtained STR profiles are compared with ATCC and DSMZ databases to determine the species origin and detect potential cross-contamination with other human cell lines.
Sterility Test
Sterility test is conducted in accordance with Chinese Pharmacopoeia General Chapter 1101, using regulatory-compliant membrane filtration and direct inoculation methods. All sterility tests are performed in an ISO Class A isolator or a Grade C+A environment, with continuous environmental monitoring throughout the testing process.
Suitability Test:Suitability tests are conducted according to regulatory requirements for different test samples to confirm that the selected method is appropriate for sterility test of the given sample.
Membrane Filtration Method:This method uses a closed membrane filtration system, allowing the filtration of large sample volumes. It effectively addresses potential microbial growth inhibitors present in test samples, and is the preferred method for filterable test samples.
Direct Inoculation Method:This method applies to test samples that cannot be tested using membrane filtration, such as: suspensions and other non-clear aqueous solutions, solid samples, non-aqueous samples, sterile medical devices, etc.
Mycobacteria Test
Canvest Bio conducts mycobacteria test in accordance with Chinese Pharmacopoeia General Guideline 1101, using the Middlebrook 7H10 agar plate culture method to ensure compliance with regulatory requirements. Testing is performed in an ISO Class A isolator or a Grade C+A environment, with continuous environmental monitoring throughout the process.
Mycoplasma Test
Canvest Bio follows Chinese Pharmacopoeia General Guideline 3301 to provide regulatory-compliant mycoplasma testing, which includes both culture method and indicator cell culture method (DNA staining method).
Culture Method: The test sample is inoculated into both solid and liquid media. After one week of incubation, the liquid culture is subcultured for a second passage, and the results of both primary and secondary cultures are observed.
Indicator Cell Culture Method (DNA Staining Method): The test sample is inoculated into indicator cells and incubated for 3–5 days before being passaged and incubated for another 3–5 days. At the end of the incubation period, the cells are stained and examined for mycoplasma contamination.
Endogenous and Exogenous Viral Contamination Testing
This testing ensures that cell lines or strains are free from potentially infectious viruses inherent to the species of origin, as well as exogenous viruses introduced through raw materials or handling procedures. The types of viruses tested and the detection methods used depend on factors such as species origin, tissue source, cell characteristics, passage history, and cultivation methods. Before testing, Canvest Bio offers consultation to help determine the most appropriate testing strategy.
Cell Morphology Observation & Hemadsorption Assay
In Vitro Culture Method Using Indicator Cells
In Vivo Animal Inoculation Methods:
Intracerebral and intraperitoneal inoculation in suckling mice
Intracerebral and intraperitoneal inoculation in adult mice
Intraperitoneal inoculation in guinea pigs
Intradermal and subcutaneous inoculation in rabbits
Chicken embryo inoculation methods:
Yolk sac inoculation
Allantoic cavity inoculation & hemagglutination assay
Retrovirus Detection
Reverse Transcriptase Activity Assay (PERT)
Infectivity Assay
Transmission Electron Microscopy (TEM)
Species-Specific Exogenous Virus Testing
The selection of viruses to be tested depends on the species origin, tissue source, and health status of the donor cells.
Rodent Cell Lines
Rodent Virus Testing
Human Cell Lines
Human Virus Detection (Q-PCR method)
Bovine-Origin Virus Test
Cell Culture Method
Fluorescent Antibody Testing
Porcine-Origin Virus Test
Cell Culture Method
Conventional PCR Method
Q-PCR Method
Other Specific Virus Test
Rodent Parvovirus Test
Cell Culture Method
Conventional PCR Method
Q-PCR Method
Vesivirus 2117 Test (Q-PCR method for CHO Cell Lines)
Tumorigenicity Testing
In Vivo Animal Inoculation Method (Nude Mice)
Soft Agar Colony Formation Assay
