Avance Biosciences

Southern Blot Services

Confirm genetic stability and transgene integrity across MCB, WCB, and EOPC with FDA-compliant Southern blot analysis.

Detect clonal rearrangements and verify copy number and integration sites to ensure consistent, contamination-free biotherapeutic production.

Avance Biosciences team has a long history of providing Southern blot analysis to support cell bank characterization for protein therapeutics development and manufacturing. Radioactive (P32) labeled hybridization probes are used in our lab for blotting and a Typhon FLA 7000 phosphorimager is used for detection. The quality of our blots is second to none.

Southern Blot Services

  • Integration Site and Structural Change Analysis: Southern Blotting is used to evaluate gene integration sites and to confirm the structure of the integrated gene.
  • Integrated Cell Clone Selection: Various integrated cell clones are evaluated with multiple probes to select clones with the desired integrations.
  • Single Clone Confirmation: We can perform limited dilution cloning of a cell bank followed by Southern blot analysis to determine whether the cell bank is comprised of a single clone.
  • Gene Knock-in/Knock-out Confirmation: Genomic DNA from animal models are extracted and analyzed using Southern blot to confirm the knock-in or knock-out of a gene.

GMP QC Analysis Process

  • Assay Development: A gene-specific hybridization probe will be prepared by PCR from the provided control plasmid and optionally confirmed by Sanger Sequencing. A pilot study will be conducted with the P32-labeled probe following our standard Southern blot procedure that has been validated as a platform method.
  • Assay Validation: A partial validation will be performed to demonstrate the specificity of the assay (probe specificity), and sensitivity of the blots.
  • Sample Testing: MCB, WCB, and EOPC along with negative and positive controls are tested to support cell bank genetic stability.

Contact Us For More Info

Our Customers Say…

Your team met the timelines we needed and did exceptional technical work. I will definitely make my management aware that Avance is a very capable partner for our bioanalytical needs.

Bioanalytical Senior Project Manager, California

Avance Biosciences™ (AB) has delivered the Sequencing data in a record time. Very impressive! We have benefited from AB’s hard work and are very grateful for that. AB team should feel proud of themselves. We thank AB team for their support and contributions, much appreciated.

Head of Quality Control, Microbial Manufacturing Service, California

My experience with Avance has been nothing but positive… I will keep sending work your way as I appreciate the attention your team provides and Avance’s creative technical team. See you soon.

Director Individualized Medicines, California

Avance has been the ideal partner in helping Mission Bio and our client,… be the first in the world to GMP qualify our single cell % transduction assay for a lentiviral gene therapy product. Excellent execution on the part of the Avance team. We look forward to more collaborations in the future.

Senior Director, Cell & Gene Therapy Business, California

From the preliminary conclusion of this work, we are already pleased to 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…

Project Manager, Belgium

Thank you so much for successfully completing this important project for us on time. We are very satisfied with the final report and thank you for taking the extra effort to customize the report format. We will definitely use your lab for future projects.

Program Manager, California

It has been a pleasure working with you and your team. The project was carried out to the highest standard and delivered in a timely manner. I will definitely recommend Avance Biosciences™’ services to colleagues and friends.

Senior Scientist, Singapore