Creative Bioarray provides CHO Cell Bank Characterizations using different methods including Fluorescent In Situ Hybridization (FISH), Locus Amplification & Sequencing and G-banded karyotyping. Transgene Mapping (Locus Amplification & Sequencing) analysis combines the next generation sequencing to selectively amplify and sequence the transgene and surrounding genomic region. G-banded karyotyping can be used to detect and analyze chromosomal abnormalities such as translocations, amplifications, or deletions in CHO cells, providing valuable information on the genetic stability of the cell line. FISH has great potential in the detection and analysis of CHO cell lines. Its applications include verification of target gene integration and copy number, assessment of chromosomal rearrangements, and quantification of specific gene expression levels. These applications can greatly contribute to the development and optimization of CHO cell lines for biopharmaceutical production.
CHO Cell Bank Characterization services from Creative Bioarray were provided to numerous pharmaceutical companies, and successfully helped their biopharmaceutical products get approved by the regulatory agency.
With a safety profile established for over 20 years, CHO cells are by far the most used production cell lines in the pharmaceutical industry. The CHO cell lines used for the production of therapeutic recombinant proteins (e.g., monoclonal antibodies, bi-specific monoclonal antibodies, growth factors, cytokines, hormones, enzymes, and vaccines) are immortalized cells with a relatively high degree of genetic plasticity. When using CHO cells as the host cell line for recombinant protein production, it's critical to thoroughly characterize the CHO cell banks and validate their clonality, in order to guarantee a stable and consistent product quality profile.
Creative Bioarray has extensive experience in characterization of cGMP CHO cell banks used in production of biologic drugs. Our CHO cell line characterization allows 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).
CHO Cell Line Characterization Tests Available:
CHO Cell Bank Characterization
Cell Line Scope
According to document ICH Q5D 'Quality of Biological Products: Derivatives and Characterization of Cellular Substrates for the Production of Biotechnology/Biological Products', Creative Bioarray performs CHO cell bank characterization on the following cell lines:
- Research Cell Bank (RCB)
- Working Cell Bank (WCB)
- Master Cell Bank (MCB)
- End-of-Production Cells (EOPC)
Cell Bank characterization is an essential step in ensuring the safety of biopharmaceutical products with the aim of confirming the identity, purity, and genetic stability of cell lines. This characterization can ensure that the cell banks are free of contaminants and are able to provide a solid, stable foundation to continue production process years down the road. International regulatory guidelines such as ICH (Q5A, Q5B, Q5D), EP and USP for cell lines characterization mainly focus on four areas:
- The origin and history of the cell line cellular morphology and growth characteristics
- Purity of the cell lines (i.e., absence of contaminating cells, microbial contaminations, and contaminations by adventitious viruses)
- Tumorigenicity and oncogenicity
- Genetic Stability
Mammalian Cell Line Characterization- Recommended Testing Plan
| Testing |
| MCB | WCB | EPC/CAL |
|---|
| Microbial Contamination | Sterility | + | + | + |
| Mycoplasma | + | + | + |
| Cell Line Stability/Identity | DNA Fingerprinting/Barcoding | + | + | + |
| Karyology | + |
| + |
| Genetic Stability | DNA Sequencing | + |
| + |
| Gene Copy Number | + |
| + |
| Restriction Endonuclease Analysis | + |
| + |
| In vitro Adventitious Viruses | + | + | + |
| In vivo Adventitious Viruses | + |
| + |
| Virus Detection by PCR (e.g., Human, Simian, Bovine, Murine, and Porcine) | + |
| + |
| Mouse, Hamster, and Rat Antibody Production Assays (MAP, RAP, and HAP) | + |
| + |
| Transmission Electron Microscopy | + |
| + |
Quotation and ordering
Our customer service representatives are available 24hr a day! We thank you for considering Creative Bioarray as your CHO Cell Bank Characterization partner.
References
- Wurm, Florian M., and Maria João Wurm. "Cloning of CHO cells, productivity and genetic stability—a discussion." Processes 5.2 (2017): 20.
- Plavsic, Mark. "Q5D derivation and characterization of cell substrates used for production of biotechnological/biological products." ICH Quality Guidelines (2017): 375-393.
- Galbraith, Daniel. "ICH Q5A: Viral Safety of Biotechnology Products." ICH Quality Guidelines: An Implementation Guide (2017): 311-335.
- Krebs, Lara E., et al. "Effective and efficient characterization of Chinese hamster ovary production cell lines using automated intracellular staining and statistical modeling." Biotechnology Progress 34.3 (2018): 570-583.
- Welch, J. (2017). Tilting at clones: A regulatory perspective on the importance of "Clonality" of mammalian cell banks. CDER/OPQ/OBP/DBRRIV April 24, 2017.
- Paul Wu, et al. "Tools and methods for providing assurance of clonality for legacy cell lines" in "Cell Culture Engineering XVI", A. Robinson, PhD, Tulane University R. Venkat, PhD, MedImmune E. Schaefer, ScD, J&J Janssen Eds, ECI Symposium Series, (2018).
- Frye, Christopher, et al. "Industry view on the relative importance of "clonality" of biopharmaceutical-producing cell lines." Biologicals 44.2 (2016): 117-122.
