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Cell Line Characterization

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Cell lines are the cellular substrates used to manufacture a variety of biopharmaceuticals such as recombinant proteins, monoclonal antibodies, therapeutic peptides, etc. Regulatory agencies require extensive cell line characterization when manufacturing these biopharmaceuticals to confirm the cell line's species of origin and history as well as to characterize and test identity, stability, and purity. CD Formulation has extensive experience in performing extensive biosafety and characterization testing on any type of cell line, including master cell banks (MCBs), working cell banks (WCBs), and in vitro age-limited (CAL) or end-of-production (EOP) cells, to meet regulatory requirements.

Why is Cell Line Characterization Important?

Proper cell line authentication is essential to ensure that no unintentional contamination of the cell line occurs during routine cell culture work. During protein/peptide biopharmaceutical development, characterizing the identity and characteristics of the cell line is particularly important and is one of the key testing procedures for quality control.

According to global regulations, all MCBs, WCBs, and CAL or EPC cells must undergo cell line characterization (CLC) to ensure the identity, purity, and safety of the cells and the final biological product. The specific testing strategy for characterizing a cell bank varies depending on a number of factors, including but not limited to the source of the cell line itself, its growth requirements, and culture history.

Explore Our Cell Line Characterization Services

CD Formulation is one of the global leaders in testing services for protein/peptide biopharmaceutical products, providing a wide range of cell line characterization and testing services to global customers to better manage and support the development of protein/peptide biopharmaceuticals.

Our biopharmaceutical analytical laboratories are equipped with advanced equipment and technologies to ensure accurate analysis and characterization of a wide range of biopharmaceutical products. Our cell bank capabilities combined with the broadest range of characterization services provide you with high-quality solutions to meet all protein/peptide biopharmaceutical development and testing needs.

Based on the document ICH Q5D "Quality of Biologics: Derivatization and Characterization of Cell Substrates for the Production of Biotechnological/Biologics", we take into account the history of the cell line and the raw materials used in the cell bank manufacturing process, providing the following cell line characterization services:

Cell lines.
Master cell bank (MCB).
Working cell bank (WCB).
End of production (EOP) bank or cell bank at in vitro cell age limit (CAL) for production.
Raw materials and final products.
Virus seed stock (VSS).

Fig. 1 Cell line characterization. Fig. 1 Cell line characterization for protein/peptide biologics. (CD Formulation)

Our Solutions

The use of cell lines to manufacture protein/peptide biopharmaceuticals requires a thorough understanding of the purity, species of origin, chromosomes, and genetic characteristics of the cell lines used. Our scientists perform extensive cell line characterization for mammalian, microbial, and CHO cell substrates, involving the following tests:

Programs	Mammalian Cell Characterization (WCB, MCB, EOP/CAL)	CHO Cell Characterization (WCB, MCB, EOP/CAL）
Microbial Contamination	Sterile. Mycoplasma. Mycobacterium. Spiroplasma.	Sterile. Mycoplasma.
Cell Line Identity	DNA barcode. Cell line. Identity. DNA fingerprint/STR. Karyotype.	DNA barcode.
Genetic Stability	DNA sequencing. Determination of gene copy number by qPCR/STR.	DNA sequencing. Gene copy number. Restriction enzyme analysis.
Virus Detection	Retroviruses: reverse transcriptase and retroviral infectivity assays In vitro adventitious viruses. In vivo adventitious viruses. Detection of specific viruses, such as bovine viruses, and minute viruses in mice. In vivo biosafety: mouse, hamster, and rat antibody production test (MAP, RAP, and HAP).	Endogenous and non-endogenous retroviruses: reverse transcriptase and retroviral infectivity assays. In vitro adventitious viruses. In vivo adventitious viruses. Detection of specific viruses, such as bovine viruses, and minute viruses in mice. In vivo biosafety: mouse and hamster antibody production test (MAP and HAP).
Tumorigenicity/Carcinogenicity	Cell proliferation assay.	-

Microbial Cell Characterization (MCB and WCB)

Bacteriophage detection.
Purity.
Identification.
Viability.
Copy number.
DNA sequencing.
Restriction endonuclease analysis.

Our Analytical Technologies

Platforms	Technologies
Phenotypic Analysis Platform	Flow cytometry (FC): Analysis of cell surface markers, intracellular proteins, and cell cycle status to determine cell phenotype and functional properties. Immunocytochemistry (ICC): Visualize protein localization and expression within cells. Immunohistochemistry (IHC): Antibodies bind to antigens within tissue sections.
Genotypic Analysis Platform	Cell line purity confirmation: Confirm that your culture is pure. Short tandem repeat (STR) analysis: Confirm cell line identity. Karyotyping and Chromosome Analysis: Ensure the authenticity of cell lines by detecting chromosomal abnormalities and genetic stability. Next-generation sequencing (NGS): Sequence entire genomes, transcriptomes, or target regions Comparative Genomic Hybridization (CGH): Detect chromosomal copy number variations (CNVs) throughout the genome.
Gene Expression Analysis Platform	Quantitative PCR (RT-qPCR/qPCR): Quantify gene expression levels to understand cellular function and regulatory mechanisms. RNA sequencing (RNA-Seq): A transcriptome analysis. siRNA knockdown: Confirm the function of silencing target genes in cells. Fluorescence in situ hybridization (FISH): Detect the presence or absence of specific DNA sequences within chromosomes or RNA within cells and tissues.
Protein Analysis Platform	Western blotting (WB): Detect and quantify specific proteins to evaluate expression levels, post-translational modifications, and protein-protein interactions. Isozyme analysis: Enzyme diversity, genetic variation, and disease biomarker analysis.
Functional Analysis Platform	Cell Proliferation and Viability: Assess cell growth rate and viability under various conditions to evaluate cell health and response to treatment.

Why Choose Us for Cell Line Characterization?

Our team of scientists has many years of combined experience in cell line characterization, ensuring that your cell line is thoroughly analyzed using the latest technologies and processes.
We offer a wide range of cell line characterization services, including identity testing, purity testing, stability testing, and functional testing, all of which are tailored to your specific needs.
We offer the ability to prepare and characterize a wide range of mammalian and microbial cell banks, including master cell banks, working cell banks, research cell banks, bioassay cell banks, and ready-to-use cell banks.
All of our services are strictly cGMP compliant.
We have cGMP-compliant facilities, including multiple class A/B suites with no animal origin and ISO 7 cleanrooms.
We offer flexible trial design options and customized solutions.

Publication

Published Data

Technology: RNA Sequencing

Journal: PLoS One.

IF: 3.24

Published: 2017

Results:

The authors developed a novel RNA sequencing data analysis method for cell line authentication. The method uses RNA sequencing information to reveal mutations in expressed transcripts, and then confirms the identity of the analyzed cells by comparison with cell-specific mutational profiles. The application of RNA sequencing data analysis for cell line authentication was demonstrated by examining the effectiveness of COLO205, DLD1, HCT15, HCT116, HKE3, HT29, and RKO colorectal cancer cell lines. The results show that this method can be successfully used to analyze and authenticate cell lines that cannot be sequenced with whole genome sequencing.

Fig. 2 RNA sequencing. Fig. 2 RNA-seq cell line authentication pipeline. (Fasterius E, et al., 2017)

Proper cell line characterization is critical to confirm the certainty of a contamination-free cell bank. CD Formulation's scientists have extensive experience and can advise on the most appropriate and cost-effective cell line testing strategy to meet regulatory requirements. Please feel free to contact us if you are interested in our services or have further questions. We look forward to working with you to promote development and innovation in the biopharmaceutical field.

References

Darling A. Validation of biopharmaceutical purification processes for virus clearance evaluation. Mol Biotechnol. 2002, 21(1):57-83.
Fasterius E, Raso C, Kennedy S, et al. A novel RNA sequencing data analysis method for cell line authentication. PLoS One. 2017, 12(2):e0171435.

How It Works

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STEP 2

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STEP 3

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