EB66 Cell Line Transgene Integrations QC & Copy Number
The duck EB66 cell line was derived following a multi-step process permitting the selection of stable cell lines that maintain some of the unique biological properties of ES cells. And EB66 cell line has the ability to indefinitely self-renew in vitro and a long-term genetic stability. Moreover, EB66 cells have the capacity to proliferate in stirred-tank bioreactors to high cell densities as suspension cells in serum-free or chemically defined culture media. The EB66 cells have been demonstrated to be highly susceptible to a very broad range of human and animal viral vaccines.
EB66 Cell Line Transgene Integrations QC & Copy Number (Locus Amplification & Sequencing) analysis from Creative Bioarray combines the next generation sequencing to selectively amplify and sequence the transgene and surrounding genomic region. This method not only uncovers insertion sites and sequences of integrated transgenes, but also enables detection of single nucleotide variations, structural variations, and transgene-transgene fusions.
According to ICH Q5B and Q5D guidelines, regulating agencies request that cell substrates must be analyzed at two time points (i.e., on the level of the Master Cell Bank and on the level of the End of Production cells) to show their genetic stability. Typical assays include those intended to confirm the integrity of the product transcript, the genome structure at integration site, and the ratio of insert gene copy number.
EB66 Cell Line Transgene Integrations QC & Copy Number (Locus Amplification & Sequencing) analysis can:
- Identify the transgene integration site(s)
- Detect structural changes in the host DNA at the transgene integration site(s)
- Sequence the entire transgene and detect any sequence variants as well as structural changes within the transgene
- Provide an estimation of the transgene copy number
The EB66 Cell Line Transgene Integrations QC & Copy Number (Locus Amplification & Sequencing) Features:
- Genetic stability analysis across various generations (e.g., MCB, WCB, EOP)
- In accordance with ICH Q5B and Q5D guidelines
- Final conclusions on stability of analyzed cell bank(s)
- Reporting meeting regulatory requirements
- Pre-finalization report review included
- Fast turnaround time
Quotation and ordering
Our customer service representatives are available 24hr a day! We thank you for considering Creative Bioarray as your EB66 Cell Line Transgene Integrations QC & Copy Number (Locus Amplification & Sequencing) Service partner.
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