Genetic Stability Tests

Regulatory agencies require genetic stability tests on cell banks used for biologicals development and manufacturing. Avance Biosciences offers a series of molecular and microbial assays for testing the genetic stability of Master Cell Banks (MCB), Working Cell Banks (WCB) and End of Production Cells (EOPC).

Genetic Stability Tests

The following assays are offered at Avance Biosciences for evaluating the genetic stability of a cell bank.

Integrated Cell Banks

    • Copy number by real-time qPCR
    • Confirmation of structure map by Southern blot
    • Number of insertion sites by Southern blot
    • Confirmatory DNA sequence by Sanger sequencing
    • Northern blot analysis

Non-integrated Cell Banks

    • Copy number by real-time qPCR
    • Confirmation of structure map by Southern blot
    • Confirmatory DNA sequence of plasmid by Sanger sequencing
    • Marker retention/plasmid loss by antibiotic resistance
    • Lytic and lysogenic phage detection

Testimonial

Thank you for your customer-oriented approach and proactive communication in the course of this study. We are happy to see the profound difference in business mindset between your organization and our previous vendor. There is for sure no comparison in the way this project was handled in the two organizations. We hope our future projects will be managed by you in the same smooth way. –Project Manager, Belgium


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