Welcome to Avance Biosciences
Avance Biosciences is a leading CRO providing CGMP and GLP-compliant assay development, assay validation, and sample testing services to support biological drug development and manufacturing activities world-wide.
Your Trusted Partner for
Advanced Biological Assay Solutions
Our leading scientists have designed and completed hundreds of analysis projects under CGMP/GLP regulations for the FDA, EPA, as well as European and Japanese regulatory agencies. This 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.
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 QUALITY STATEMENT
Our established quality system is based on the requirements of Good Laboratory Practices, current Good Manufacturing Practices, and Quality System Regulation as promulgated by the U.S. Food and Drug Administration 21 CFR Part 58, 21 CFR Parts 210, 211, and 820 respectively, and by European, Japan, and other international regulatory agencies.
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!