Viral contaminants in cell lines used for the production of biologics products pose a significant risk to human health. Adventitious agents testing is essential when assessing the safety and purity of these products during development.
Regulatory guidelines include adventitious agents testing as part of the routine characterization and qualification of cell substrates and other biological materials used in the production of biopharmaceuticals. Next generation sequencing (NGS) is quickly gaining regulatory agencies’ acceptance as a sensitive and un-biased detection method for adventitious agents.
Working closely with a major US-based pharmaceutical client, Avance Biosciences developed its NGS viral detection work flow that is capable of detecting various viruses (dsDNA, ssDNA, ssRNA, and dsRNA viruses) at low concentrations. Avance Biosciences is positioned to be a strategic partner with our pharmaceutical clients in establishing this powerful tool for testing viral contaminants in cell substrates and biological products.
Applications
- Testing adventitious viruses in biological products
- Raw materials
- Final products
- Matrix with viral spike-in
- Testing adventitious viruses in cell substrates
- Cell culture
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
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!
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.