A world-leading CRO specialized in GLP/GMP compliant assay development, assay validation, and sample testing services
Molecular Biology & Microbiology Assays
GLP/GMP compliant Sanger sequencing, next-gen sequencing, real-time PCR, ddPCR, phage testing, Southern blot, and many more
Biological Drug Development Support
Providing custom assay solutions in support of all phases of drug development and manufacturing activities
Cutting-edge Assay Technologies
First in the world to provide GLP/GMP compliant next generation DNA sequencing and ddPCR assays for regulatory submissions
Welcome to Avance Biosciences
Avance Biosciences is a leading CRO providing GLP/GMP-compliant assay development, assay validation, and sample testing services to support biological drug development and manufacturing activities world-wide.
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.
Avance Biosciences’ cGMP/GLP compliant genomic and microbial assays make use of the advanced technologies including real-time PCR, ddPCR, Sanger sequencing, next-gen sequencing, Southern blot, and more.
Our leading scientists have designed and completed hundreds of testing 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.
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.
Avance Biosciences offers real-time PCR, digital PCR, and NGS amplicon assay development, assay validation, and sample testing services to support gene therapy and cell therapy preclinical biodistribution studies and clinical trial pharmacokinetics studies.
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.
With its team’s extensive experience in Sanger sequencing, next generation DNA sequencing, Southern blot, real-time PCR, digital PCR, and other molecular biology testing methods, Avance Biosciences is positioned to support our clients worldwide for their agrigenomics research and development.
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.
MEET OUR MANAGMENT
Our experienced technical and quality staff have worked together for more than two decades offering GLP/cGMP compliant molecular biology and microbiology assays to support regulatory submissions.
Dr. Huang has extensive management experiences in the biotechnology service industry. Before he joined Avance Biosciences, he held senior management positions in several biotechnology service companies…
DAVID WALL, PhDVP of Operations, Co-founder
Dr. Wall brings 20 years of experience in molecular biology industry and a profound knowledge of both quality compliance and the biological sciences…
LI (KIMBERLY) LI, PhDVP of Project Management, Co-founder
Dr. Li has extensive experience in the molecular biology industry and possesses strong technical leadership in DNA sequencing, QPCR, Southern Blot, and other molecular biological methods…
Avance Biosciences provides custom cGMP/GLP compliant testing solutions to evaluate the identity, purity and genetic stability of biologics in support of drug research, preclinical safety studies, clinical trials and cGMP manufacturing.
With its breadth of service platforms and experienced scientific team, Avance Biosciences offers a broad range of custom assay development services to support all phases of drug development.
We are dedicated to high-quality services from the start of your project to the finish. Send us a quick message with your questions to find out what Avance can do for you.
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!