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.
Equipped with the state-of-art ABI 7900 HT Sequence Detection System, Avance Biosciences offers both Real-Time PCR or End-Point PCR assays.
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.
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
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, 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!
