Cell Line Characterization

Creative Bioarray offers powerful cytogenetic techniques including FISH (Fluorescence in situ Hybridization), arrayCGH (Comparative Genomic Hybridization), Transgene Mapping (Locus Amplification & Sequencing) and G-banded analysis that can help with cell line characterization to address various questions related to genetic abnormalities and variants in cell lines.

Here are some specific problems we can help resolve:

  • Genetic Stability: These techniques can confirm the genetic stability of cell lines over time or under different culture conditions, which is crucial in any experiment involving cell lines.
  • Cross-contamination and Misidentification: They can detect cross-contamination and misidentification of cell lines, which are common problems in cell culture.
  • Chromosome Abnormalities: FISH, arrayCGH, and G-banded analysis can uncover chromosomal abnormalities in cell lines such as translocations and deletions. This is particularly useful in research involving CHO or other cell lines where such abnormalities are common.
  • Gene Amplification and Deletion: They are key in identifying gene amplification and deletion events that could impact protein production, drug response, and other cellular processes.
  • Expression Analysis: These techniques can be used to analyze the expression of specific genes in cell lines, which can be critical in studies of gene function and drug development.

Karyotype generated from a CHO Cell line.Figure 1. Karyotype generated from a CHO Cell line.

Normal Karyotype generated from human male cultured cells (46, XY)Figure 2. Normal Karyotype generated from human male cultured cells (46, XY)

FISH signals on metaphase cellsFigure 3. FISH signals on metaphase cells

FISH signals on interphase nucleiFigure 4. FISH signals on interphase nuclei

Probe signals from the XXX HC probe and LC probe were observed at the same position.Figure 5. Probe signals from the XXX HC probe and LC probe were observed at the same position. One pattern of insertion was found in 200 CHO cells. Variations caused by chromosomal abnormalities were not regarded as different pattern. Pattern 1 (200/200 cells) Centromeric region of chr.10

Example of KARS Gene FISH signals in 2 cell linesFigure 6. Example of KARS Gene FISH signals in 2 cell lines

Representative M-FISH karyotype of K562 cell.Figure 7. Representative M-FISH karyotype of K562 cell.

Moreover, in line with industrial applications, these characterizations are necessary to ensure the quality and consistency of biopharmaceuticals produced by cell lines. Complying with regulatory standards, such cell line characterizations can provide the necessary documentation for cell line banks, significantly supporting applications for manufacturing licenses in the biopharmaceutical industry.

FISH, arrayCGH, Transgene Mapping (Locus Amplification & Sequencing) and G-banded service play crucial roles in cell line characterization, enabling researchers to investigate genetic anomalies, identify disease-driving genetic alterations, assess drug response, detect chromosomal abnormalities, and validate cell line authenticity. By leveraging these techniques, scientists can gain a deeper understanding of cell line biology, contributing to the development of targeted therapies.

Being regarded as a starting point in production, cell line characterization improves control and consistency in the manufacturing of the products. Its importance is well recognized for better quality assurance and the uniform supply from clinical trials to commercial use.

Creative Bioarray has extensive experience in characterization of cGMP cell banks used in production of biologic drugs. And we offer a broad range of cell line characterization services allow you to efficiently streamline your cGMP-compliant manufacturing processes and accelerate toward successful commercialization. And our reporting fulfils FDA and EMA regulatory requirements for pharmaceuticals for human use (ICH guidelines Q5B and Q5D, CTD Quality module, section 3.2.S.2.3).

Our Cell Line Characterization testing and release of cell banks for use in manufacturing programs:

  • Master Cell Bank (MCB)
  • Working Cell Bank (WCB)
  • End of Production Cell Bank (EOPC)

Our Cell Line Characterization services are featured with:

  • Well-developed protocols for cell line characterization
  • Various mammalian cells, including CHO, Vero, HEK293, BHK-21, etc.
  • Comprehensive quality assurance process
  • Fully characterized to meet regulatory requirements
  • Competitive prices
  • Fast turnaround time

Cell Line Characterization Tests Available:

Cell Bank Characterization

  • Cell Line Clonality Assessment
  • Cell Line Genetic Stability (MCB, WCB, EOP) Testing
  • Cell Line Transgene Integrations & Copy Number QC (Locus Amplification & Sequencing)
  • Cell Line Transgene Integrations QC (FISH)
  • Cell Chromosomal Aberration Analysis
  • Cell Chromosomal Comparative Genomic Hybridization (aCGH)

With years of experience and a c-GMP-qualified laboratory, Creative Bioarray cell bank characterization ensures that your biological production process complies with international guidelines. Guaranteed quality enables us for worldwide partnerships to accelerate innovation.

For more details, please feel free to contact us for project quotations and more detailed information.

All products and services on this website are only suitable for non-medical purposes.

Cell Line Characterization


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