Professional technology integration to support the entire R&D process

The core principle of NGS-based cell authentication is to obtain extensive sequence reads from the cell genome through massively parallel sequencing, which are then compared against known reference genome databases.

1. Comprehensiveness: Unlike traditional methods that detect only a limited number of STR loci (typically a dozen), NGS can analyze millions of single nucleotide polymorphisms (SNPs) across the entire genome. Each SNP provides a discrete data point, and collectively these points form the unique genetic fingerprint of a cell line.

2. High Resolution: By analyzing SNP profiles, NGS can distinguish cells from different individuals (even within the same species) with high precision, identify genetic drift and mutations that occur during long-term cell line propagation, and detect minor 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 can be simultaneously analyzed to detect microbial contamination, including mycoplasma and viruses, providing efficient dual-target detection.

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

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.

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.

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 growing adoption of NGS technology, NGS-based cell authentication services are rapidly emerging as a transformative approach to quality control in the life sciences. Offering unparalleled accuracy, broad coverage, and efficiency, these services safeguard the integrity of scientific research data and the reliability of biopharmaceutical manufacturing, serving as a key technological enabler for the sustainable and trustworthy development of the field. Choosing NGS for cell characterization demonstrates the highest standards of scientific rigor and quality.

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