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).
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 Vero cell bank characterization on the following cell lines:
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:
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 | + | + |
Our customer service representatives are available 24hr a day! We thank you for considering Creative Bioarray as your Vero Cell Bank Characterization Service partner.
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