Avance Biosciences is a leading CRO providing CGMP/GLP-compliant assay development, assay validation, and sample analysis services to support biological drug development and manufacturing activities world-wide.
Our clients benefit from collaboration with a scientific team with decades of experience designing, validating and executing regulatory submission level assays for biological samples.
Avance Biosciences is a leading CRO providing CGMP/GLP-compliant assay development, assay validation, and sample analysis services to support biological drug development and manufacturing activities world-wide.
Our clients benefit from collaboration with a scientific team with decades of experience designing, validating and executing regulatory submission level assays for biological samples.
The Avance Biosciences team has more than three decades of experience providing biological testing services to support cell and gene therapy (CGT) development and manufacturing. Our expertise in real-time PCR, digital droplet PCR (ddPCR), next-generation sequencing (NGS), and many other molecular biology, cell biology, and microbiology tools enable us to provide testing solutions that bolster our clients’ CGT programs.
Avance Biosciences is a leading provider of biologics safety testing for both eukaryotic and prokaryotic development projects, offering Sanger sequencing, next generation DNA sequencing, real-time PCR, digital PCR, Southern blot, northern blot and other molecular biology and microbiology methods to support our clients’ biological drug development and manufacturing needs.
It is critical for diagnostic device makers to validate their assays for regulatory submissions. Avance Biosciences offers a series of “Gold Standard” methods, such as Sanger sequencing and real-time PCR, that are often required by regulatory agencies for diagnostic test validation. We specialize in assay development, assay qualification or validation, and sample testing that complies with GLP and CGMP regulations.
The FDA, EMA, and other regulatory agencies require rigorous protein analysis, using validated assays, to ensure drug efficacy and safety. Our CGMP and GLP-compliant protein analysis services are built on sound science and regulatory expertise, so we can develop and validate the best immunoassays for your program, perform accurate sample testing, and go above and beyond the needs of regulatory bodies.
Our Customers Say…
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!
