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1.877.909.5210|sales@avancebio.com

MENUMENU
 * Home
 * Applications
   
   * Assay Development & Validation
     
     
     
      * Assay Development
     
      * Cross Validation by Sanger Sequencing
     
      * Cross Validation by Real-Time PCR
     
     
     
     Cell and Gene Therapy Assays
     
     
     
      * Biodistribution Studies
     
      * Potency Assay Development
     
      * CRISPR Edited Gene Assays
     
      * NGS-Based ID Testing
     
      * CAR-T and Other Cell Therapy Assays
     
      * Single-cell Multi-omics Analysis
     
     
     
     Biologics Assays
     
     
     
      * RNA Therapeutics Analysis
     
      * Cell Line Development Assays
     
      * Cell Bank Assays                     
     
      * Viral Seed Assays                              
     
      * Clinical Trial Genetic Assays
     
      * Lot Release Assays
     
     
     
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      * Preclinical / Clinical Biodistribution Services
     
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 * Services
   
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      * Copy Number Variation Analysis
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      * Phage Assays                     
     
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 * Company
   
   * Avance Biosciences™
     
     
      * About Us                             
     
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     SOT – ToxExpo – March 10-14
     
     BioProcess International – US West – March 11-14
     
     Boston Society Gene & Cell Therapy Conference – March 21
     
     American Society for Clinical Pharmacology & Therapeutics (ASCPT) Annual
     Meeting – March 27-29
     
     World Vaccine Congress – April 1-4
     
     American Society for Gene and Cell Therapy (ASGCT) Annual Meeting – May
     7-11
     
     American Association of Pharmaceutical Scientists (AAPS) National Biotech
     Conference – May 13-16
     
     Workshops on Recent Issues in Bioanalysis (WRIB) – May 6-10
     
     
     
     The Latest News
     
     
     
     
     
     FDA issues final guidelines on incorporating human genome editing in gene
     therapy products
     FDA’s Innovative Approach to Global Gene Therapy Collaboration
     FDA issues new draft guidelines on potency assurance for cell and gene
     therapy products
     The FDA’s approval of Casgevy and Lyfgenia represents a transformative
     moment in the evolution of gene therapy
     A Historic Milestone as UK Regulatory Body Approves Revolutionary CRISPR
     Treatment
     Join Avance Biosciences™ at These Upcoming Analytical Development Summits
     Join Avance Biosciences™ at the CRISPR-Based Therapy Analytical Development
     Summit – Oct 2023
     Donor kidneys carrying human transgenes results in life-supporting organ
     function and recipient survival of over two years
     Gene therapy biotech LEXEO Therapeutics files for IPO
     FDA takes action on updated mRNA COVID-19 vaccines
     
     
     
     Contact Us
     
     
     
     
     PHONE US
     
     Main: (713) 849-3380 Toll Free: (877) 909-5210 Quality: (713) 849-3508
     
     
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     sales@avancebio.com customerservice@avancebio.com
     
     
     VISIT US
     
     Avance Biosciences™ Inc. 9770 West Little York Road Houston, TX 77040
     
     
 * Library
   
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      * Single-cell Multi-omics Analysis
     
     
      * CRISPR Edited Gene Assays
      * Cell Therapy Assays
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      * RNA Therapeutics Analysis
     
      * Cell Line Development Assays
     
      * Cell Bank Assays
     
     
     
     
     Technical Bulletins
     
     
      * GUIDE-Seq/iGuide for CRISPR On/Off Target Analysis
      * NGS for Biologics Development Support
     
      * Phage Testing of Bacterial Cultures
     
     
     
     Press Releases
     
     
     
      * Oct 2018 – Avance Biosciences Completes Successful FDA Inspection
     
      * Feb 2021 – Avance Biosciences Expanding Houston Campus in Support of
        Cell and Gene Therapy Drug Development
     
      * Feb 2022 – Mission Bio Transfers First Tapestri GMP-Ready CGT Assay to
        Avance Biosciences for Cell-Based Therapies
      * May 2022 – Avance Biosciences Announces Validation of New Facilities
      * March 2023 – Avance Biosciences licenses SeQure Dx’s GUIDE-seq
        off-target NGS analysis technology
     
     
     
     In The News
     
     
     
      * Pharma Tech Outlook – Nov 2020
     
      * Genetic Engineering News – June 2022
     
     
 * Careers
 * Quality
 * Contact Us
 * 

 * Home
 * Applications
   * Assay Development & Validation
     * Assay Development
     * Cross Validation by Sanger Sequencing
     * Cross Validation by Real-Time PCR
   * Biologics Assays
     * Biological Discovery Assays
     * Cell Line Development Assays
     * Cell Bank Assays
     * Viral Seed Assays
     * Lot Release Assays
     * Clinical Trial Genetic Analysis
   * Testing for Gene & Cell Therapy
     * Biodistribution DNA Assays
     * CAR-T & Other Cell Therapy Testing
     * CRISPR Edited Gene Testing
   * Agriculture Genomic Testing
     * Genotyping for Seeds and Plants
     * GMO Characterization
 * Platforms
   * Sanger Sequencing
   * Next-Gen Sequencing
   * Real-Time PCR
   * Digital PCR
   * Southern / Northern Blotting
   * Microbial Analysis
   * Other Molecular Biology Services
 * Company
   * News & Events
   * Contact Us
 * Contact Us
   * Information and Quote Request
   * Driving Directions
 * Search


 * Home
 * Applications
   * Assay Development & Validation
     * Assay Development
     * Cross Validation by Sanger Sequencing
     * Cross Validation by Real-Time PCR
   * Biologics Assays
     * Biological Discovery Assays
     * Cell Line Development Assays
     * Cell Bank Assays
     * Viral Seed Assays
     * Lot Release Assays
     * Clinical Trial Genetic Analysis
   * Testing for Gene & Cell Therapy
     * Biodistribution DNA Assays
     * CAR-T & Other Cell Therapy Testing
     * CRISPR Edited Gene Testing
   * Agriculture Genomic Testing
     * Genotyping for Seeds and Plants
     * GMO Characterization
 * Platforms
   * Sanger Sequencing
   * Next-Gen Sequencing
   * Real-Time PCR
   * Digital PCR
   * Southern / Northern Blotting
   * Microbial Analysis
   * Other Molecular Biology Services
 * Company
   * News & Events
   * Contact Us
 * Contact Us
   * Information and Quote Request
   * Driving Directions
 * Search



Homewebmaster2024-01-17T13:47:21+00:00
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A world-leading CRO specialized in GLP/GMP compliant assay
development, assay validation, and sample testing services LEARN MORE 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 CGMP AND GLP-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.




LEARN MORE






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.




LEARN MORE






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.




LEARN MORE






CUTTING EDGE SCIENCE






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.




LEARN MORE






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.





CELL AND GENE THERAPY ASSAYS



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.


BIOLOGICS ASSAYS



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.





ASSAY DEVELOPMENT & VALIDATION



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.


CGMP/GLP PROTEIN ANALYSIS SERVICES



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.





MEET OUR MANAGMENT






OUR EXPERIENCED TECHNICAL AND QUALITY STAFF HAVE WORKED TOGETHER FOR MORE THAN
TWO DECADES OFFERING GLP/GMP COMPLIANT MOLECULAR BIOLOGY AND MICROBIOLOGY ASSAYS
TO SUPPORT REGULATORY SUBMISSIONS.






XUENING (JAMES) HUANG, PhDGeneral Manager, Co-founder
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 Quality, Co-founder
Dr. Wall brings more than 20 years of experience in the molecular biology and
microbiology industry and has a profound knowledge of both GxP 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…





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!






CONTACT INFORMATION

 * 9770 West Little York Road, Houston TX 77040
 * 1.877.909.5210
 * sales@avancebio.com






ABOUT US

Avance Biosciences™ is specialized in assay development, assay validation, and
sample testing using Next Generation DNA Sequencing, Sanger Sequencing,
Quantitative PCR, and other biological methods to support Drug Development and
Manufacturing.

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!



NEWSLETTER SIGNUP






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THE LATEST NEWS



FDA issues final guidelines on incorporating human genome editing in gene
therapy products
FDA’s Innovative Approach to Global Gene Therapy Collaboration
FDA issues new draft guidelines on potency assurance for cell and gene therapy
products
The FDA’s approval of Casgevy and Lyfgenia represents a transformative moment in
the evolution of gene therapy
A Historic Milestone as UK Regulatory Body Approves Revolutionary CRISPR
Treatment
Join Avance Biosciences™ at These Upcoming Analytical Development Summits
Join Avance Biosciences™ at the CRISPR-Based Therapy Analytical Development
Summit – Oct 2023
Donor kidneys carrying human transgenes results in life-supporting organ
function and recipient survival of over two years
Gene therapy biotech LEXEO Therapeutics files for IPO
FDA takes action on updated mRNA COVID-19 vaccines


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