Cell Authentication(NGS)

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Cell Authentication(NGS) Service

In today's rapidly developing life science research and biopharmaceutical industries, cell lines serve as essential experimental models and productivity tools, and the accuracy and purity of their identity are crucial. However, issues such as cell cross-contamination, interspecies contamination, and misidentification have long been significant risks plaguing both research and industry, potentially sabotaging years of research or causing significant production losses. Traditional cell authentication methods, such as STR profiling, are widely used but have limitations. The rise of next-generation sequencing (NGS) technology has revolutionized cell authentication, providing unprecedented accuracy and information.

Definition

NGS Cell Authentication Services utilize high-throughput sequencing technology to perform deep sequencing of the entire genome or targeted regions of a cell sample. By comparing and analyzing sequence information, NGS enables precise identification of cell species, species of origin, and tissue type, as well as detection of microbial contamination (such as mycoplasma). It not only confirms whether a cell is the expected type but also reveals its unique genetic background and stability at a deeper level, serving as a "genetic ID card" that ensures the reliability of experimental data and production safety.

Definition

Principle

The core principle of NGS cell authentication lies in obtaining massive amounts of sequence fragments from the cell genome through massively parallel sequencing, which are then compared and analyzed against known reference genome databases.

1. Comprehensiveness: Unlike traditional methods that only detect a limited number of loci (such as a dozen or so STR loci), NGS can scan millions of single nucleotide polymorphisms (SNPs) across the entire genome. Each SNP is a point of information, and these numerous points of information collectively constitute the unique "genetic fingerprint" of a cell line.

2. High Resolution: By analyzing SNP profiles, NGS can extremely accurately distinguish cells from different individuals (even those of the same species), identify genetic drift and mutations that occur during long-term cell line generation, and even detect tiny subclonal populations within a cell population.

3. Simultaneous Multi-Target Detection: In a single sequencing run, nuclear genomic information for cell identity can be obtained, while non-host sequences within the sequencing data can also be analyzed to simultaneously detect the presence of microbial contamination such as mycoplasma and viruses, achieving "killing two birds with one stone" detection efficiency.

Workflow: From Sample to Report

A standard NGS cell identification service typically includes the following key steps:

Sample Submission and DNA Extraction

The user submits a small cell sample (cell pellet or culture), and the service provider uses high-quality kits to extract genomic DNA, ensuring DNA integrity and purity.

Library Construction

The extracted DNA is randomly fragmented into small fragments, and specific sequencing adapters are ligated to each end to construct a library ready for on-device sequencing. For targeted sequencing solutions, probes are also used to enrich for specific genomic regions relevant to cell identification.

On-device Sequencing

The constructed library is loaded onto an NGS sequencer (such as the Illumina NovaSeq or MiSeq series) for high-throughput sequencing, generating hundreds of millions of short sequence reads.

Bioinformatics Analysis

This is the core step. The massive amount of sequencing data generated is processed as follows:

Quality Control

Filter out low-quality sequences and sequences with adapters.
* Sequence Alignment: Align high-quality sequences with reference genomes of humans or other species.

* Variant Calling: Identify SNP differences between the sample and the reference genome.

* Identity Comparison: Compare the SNP profile of the sample with reference pedigrees from international standard cell repositories (such as ATCC and ECACC) to calculate kinship or compatibility.

* Contamination Analysis: Compare sequences that do not match the host genome with microbial databases to detect contamination such as mycoplasma.

Report Generation and Interpretation

Generate a detailed and easy-to-understand identification report, including: cell identity confirmation results, compatibility with reference pedigrees, genetic stability assessment (such as loss of heterozygosity analysis), microbial contamination detection results, and provide professional conclusions and recommendations.

Advantages:

Extremely high accuracy and resolution

The vast number of SNP loci provides far more information than the limited number of STR loci, making authentication results more precise and less prone to misjudgment.

Powerful contamination detection

No separate mycoplasma testing is required; a single sequencing run can comprehensively screen the "health" of a cell sample.

Rich additional information

Additional information such as genetic stability, copy number variations (CNVs), and mutational load can be obtained, providing more dimensional data for research.

Automation and standardization

From library construction to analysis, the process is highly automated, reducing human error. Results are objective, reproducible, and easily standardized and compared across platforms.

Future traceability

Complete NGS data can be permanently preserved, allowing for future rediscovery of its value with advances in analytical tools or new discoveries.

Application Scenarios

Research Institutions and Universities: Authenticate cell lines before research commencement, publication, or cell bank storage to ensure the reliability and reproducibility of research results.

Biopharmaceutical Companies:Cell Line Development (CLD): During the development of biopharmaceuticals (e.g., monoclonal antibodies), confirm the clonality and monitor the genetic stability of candidate production cell lines (e.g., CHO cells).

Quality Control: Mandatory authentication of Master Cell Banks (MCBs), Working Cell Banks (WCBs), and final production cells to comply with regulatory requirements of drug regulatory agencies such as the FDA, EMA, and NMPA.

Clinical Research and Cell Therapy: Ensure the correct source and absence of cross-contamination for cells used in advanced therapies such as CAR-T and stem cell therapy, ensuring the safety and efficacy of treatment.

Cell Bank Preservation and Exchange: International cell banks and laboratories provide authoritative NGS authentication certificates when storing and distributing cells, establishing a "gold standard" for cell documentation.

With the continuous decline in sequencing costs and the increasing adoption of technology, NGS-based cell authentication services are rapidly becoming a new paradigm for quality control in the life sciences. With its unparalleled accuracy, comprehensiveness, and efficiency, it provides a solid defense for the authenticity of scientific research data and the safety of biopharmaceutical production, serving as a key technological enabler for the healthy and reliable development of the field. Choosing NGS for cell characterization means choosing the highest commitment to science and quality.

If you are interested in ordering, please contact us
Email: sales@cobioer.com

Definition

Definition

Principle

Workflow: From Sample to Report

Extremely high accuracy and resolution

Powerful contamination detection

Rich additional information

Automation and standardization

Future traceability

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