Vero Cell Bank Characterization

Vero cells are considered as the most widely accepted continuous cell line by the regulatory authorities for the manufacture of viral vaccines for human use. Reasons for the extensive use of the Vero cell line are the consistent high viral yields and susceptibility to infect a multiple range of viruses, as well as relatively easy adaptation for growth in bioreactors on microcarriers, thus allowing up-scaling without loss of cell productivity.

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

Vero 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 Vero Cell Bank Characterization Service partner.

References

1. Plavsic, Mark. "Q5D derivation and characterization of cell substrates used for production of biotechnological/biological products." ICH Quality Guidelines (2017): 375-393.
2. Galbraith, Daniel. "ICH Q5A: Viral Safety of Biotechnology Products." ICH Quality Guidelines: An Implementation Guide (2017): 311-335.
3. 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.
4. 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).
5. Frye, Christopher, et al. "Industry view on the relative importance of "clonality" of biopharmaceutical-producing cell lines." Biologicals 44.2 (2016): 117-122.
6. Dangi, A. K. Cell Line Techniques and Gene Editing Tools for Antibody Production: A Review. Front Pharmacol. 2018; 9: 630. doi: 10.3389/fphar.2018.00630