As part of our GLP/GMP Cell Bank Characterization services, Southern blot analysis is used evaluate the number of integration site and the expression construct structural integrity. Both integration site number and structure will be evaluated and may be compared to a reference if available.

DNA will be extracted from the test article, non-transfected host cells, followed by UV quantitation and electrophoresis analysis. After restriction digest with up to 4 enzymes, which cut once within the expression system, DNA samples are separated by electrophoresis and then transferred and UV cross-linked to a positive charged nylon membrane. Probe DNA will be prepared and labeled with either Chemiluminescent or 32P chemistry. After hybridization, the captured fragments will be visualized by exposure of X-Ray film. After producing the autoradiogram, the estimation of integration site number and the size of transgene will be reported.

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Services

GLP/GMP Compliant
Genomics & Biological Services

  • Experienced scientists functioning as project managers or study directors

  • Independent quality unit assuring regulatory compliance

  • Methods validated per ICH GLP/GMP guidelines – also research grade testing available

  • Rigorous sample tracking and handling procedures to prevent mistakes and cross-contamination

  • Controlled laboratory environment to prevent cross-contamination

When you partner with Avance Biosciences™, you gain a CRO partner that is creative, collaborative and dedicated to sound science with a focus on the regulatory requirements our partners require. Contact our technical staff to discuss how we can support you in your project!

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Dedication to Quality

Dedication To Quality

The Avance Biosciences™ team is committed to strict adherence to CGMP and GLP regulations enacted by the US, European, Japanese, and other international regulatory agencies.

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Extensive Experience

Open Communication

Our team has extensive knowledge and experience working with scientists, QA/QC professionals, and project managers from over 100 pharmaceutical and biotechnology companies and organizations throughout the world.

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Open Communication

Open Communication

Transparency and integrity are two of our core values. Our well-trained, friendly, and professional study directors and project managers strive to complete your projects on-time with open communication channels and to your specifications.

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Cutting Edge Science

Open Communication

Avance Biosciences™’ CGMP/GLP compliant genomic and microbial assays make use of the advanced technologies including real-time PCR, ddPCR, Sanger sequencing, next-gen sequencing, Southern blot, and more.

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