Your regulatory submission project is so important to you and your organization that it is critical to select a reliable service provider for your next GLP DNA sequencing project. Avance Biosciences’ DNA sequencing services include a broad range of offerings that meet your needs. Our experienced scientists can execute DNA sequencing techniques of all complexities including difficult templates, viral, bacterial and genomic DNA, as well as projects tailored to your needs.
The FDA continues to require the completion of two-fold double stranded sequencing for identity and safety testing of products produced from cell lines via integrated or non-integrated vectors because DNA/RNA-genetic sequences are susceptible to random mutation. Sequencing reactions are performed using Applied Biosystems BigDye V3.1 Chemistry and analyzed on ABI 3730XL DNA Analyzers.
Two-fold coverage on both DNA strands (4-fold coverage total)
Sequencing methods validated per ICH guidelines
FDA 21 CFR Part 58 and OECD GLP compliance
FDA 21 CFR Part 11 compliance
Next Generation Sequencing (NGS) has the potential to unlock causative factors from our genetic material. NGS also represents a technological advancement using array-based sequencing that will improve many aspects of scientific research and advance the field of personalized medicine. Avance Biosciences offers Next Generation sequencing with Illumina’s high throughput next generation sequencing platforms.
Reports readily accepted by regulatory authorities
Independent quality unit assuring regulatory compliance
Weekly report on project progress
Open communication between our study directors and clients
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.
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
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.
Cutting Edge Science
Avance Biosciences’ cGMP/GLP compliant genomic and microbial assays make use of the advanced technologies including real-time PCR, digital PCR, Sanger sequencing, next generation sequencing, and more.