Biopharmaceutical products require the removal of host cell impurities as a critical step in product purification. Companies that produce biopharmaceutical products must verify the quantity of host cell DNA impurities carried over through the purification process and in the drug’s final dosage to meet or exceed regulatory guidelines.

Avance Biosciences has developed a number of accurate and sensitive target-specific QPCR assays to detect residual host cell DNA in biopharmaceutical products from a number of common host cell lines (E. coli, CHO cells, and yeast). Our custom-designed GMP/GLP compliant qPCR method offers a powerful tool to address the safety concerns and satisfy the requirements for regulatory agencies worldwide.

With our expertise and extensive experience in the “Gold-standard” real-time qPCR assay development and validation, Avance Biosciences offers customized residual DNA analysis services to determine the residual host cell DNA in biological products derived from cell substrates.

Avance Biosciences also offers Southern blot service to determine the size distribution of residual DNA contaminants in various steps of biologics manufacturing processes. DNA extracted from testing samples are separated by Agarose gel electrophoresis and detected by Southern blotting using a 32P labeled probe.


CGMP/GLP 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

Have questions?

We are dedicated to timely, high-quality service from the start of your project to the finish. Send us a note or give us a call to find out what Avance can do for you.


Ready to get started?

Give us a little background on your needs and the goals of your project, and we’ll send a preliminary quote including: tasks, deliverables and a no-obligation cost estimate.


Our Customers Say…

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, we give you undivided attention, share our experience and knowledge, and respond to your needs in a timely manner. Contact our technical staff to discuss how we can support you in your project!


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.


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.


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.


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.