Products derived from transgenic organisms, for use as human or animal drugs or for biologics are regulated by the FDA for safety and efficacy. The FDA requires Southern blots to confirm that the structure of the genomic DNA of a cell bank is stable and unchanged and that no clonal rearrangement has occurred. Southern blots also confirm target identity as matching the hybridization probe, size as compared to a molecular weight marker, and abundance. Northern blots confirm the gene expression pattern of a cell bank.
Avance Biosciences™, Inc. provides all necessary expertise for Southern blot projects from nucleotide extraction to probe design. We offer Southern blot analysis to support gene discovery and confirmation, gene mapping, evolution and development studies, diagnostics, and forensics tests.
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.
Science, Compliance, Service
Experienced scientists functioning as project managers or study directors
Controlled laboratory environment to prevent cross-contamination
Rigorous sample tracking and handling procedures to prevent mistakes and cross-contamination
Methods validated per ICH GLP/GMP guidelines – also research grade testing available
Projects customized and tailored to suit your needs
Independent quality unit assuring regulatory compliance
Transparent process flow and weekly report on project progress
Professional project reports ready for regulatory filing
Fast turn-around time & Competitive pricing
GLP/GMP Compliant
Biological Assay Services
Our Customers Say…
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
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
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
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!
Dedication to Quality
The Avance Biosciences™ team is committed to strict adherence to GLP and CGMP regulations enacted by the US, European, Japanese, and other international regulatory agencies.
Extensive Experience
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.
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.
Cutting Edge Science
Avance Biosciences™’ GLP/GMP compliant genomic and microbial assays make use of the advanced technologies including real-time PCR, digital PCR, Sanger sequencing, next generation sequencing, and more.