MDBK Cell Bank Characterization

MDBK cells were obtained in 1957 from renal tissue of an adult calf (Madin & Darby, 1958). It has high sensitivity to many viruses, especially vesicular stomatitis (Indiana strain), infectious bovine rhinotracheitis virus (IBR), bovine parvovirus, bovine adenovirus I–III, and parainfluenza virus 3. The most significant utilization area of MDBK cells is industrial vaccine production and propagation of attenuated vaccine viruses.

Creative Bioarray has extensive experience in characterization of cGMP MDBK cell banks used in production of biologic drugs. Our MDBK 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).

MDBK Cell Line Characterization Tests Available:

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

Quotation and ordering

Our customer service representatives are available 24hr a day! We thank you for considering Creative Bioarray as your MDBK Cell Bank Characterization Service partner.

References

1. Wurm, Florian M., and Maria João Wurm. "Cloning of CHO cells, productivity and genetic stability—a discussion." Processes 5.2 (2017): 20.
2. Plavsic, Mark. "Q5D derivation and characterization of cell substrates used for production of biotechnological/biological products." ICH Quality Guidelines (2017): 375-393.
3. Galbraith, Daniel. "ICH Q5A: Viral Safety of Biotechnology Products." ICH Quality Guidelines: An Implementation Guide (2017): 311-335.
4. 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.
5. 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.
6. 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).
7. Frye, Christopher, et al. "Industry view on the relative importance of "clonality" of biopharmaceutical-producing cell lines." Biologicals 44.2 (2016): 117-122.