Residual DNA Assayswebmaster2022-11-18T16:51:39+00:00
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 GLP/GMP 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.
Avance Biosciences™, Inc. provides all necessary expertise for Southern or Northern 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.
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
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.
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 CGMP and GLP regulations enacted by the US, European, Japanese, and other international regulatory agencies.
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.
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.
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.