Ensure the Success of Your Biological Drug Development

Avance Biosciences is a world leading CRO providing CGMP/GLP compliant biological testing solutions supporting the biological drug development pipeline from discovery through manufacturing.

What We Do

Biopharmaceutical drug development requires extensive biological testing for raw material release, in-process quality control, and final product characterization to secure product safety and satisfy the regulatory requirements of the FDA and other regulatory agencies.

We offer CGMP/GLP-compliant assay development, assay validation, and sample testing services to ensure strict regulatory compliance and a smooth journey to market. Using ICH guidelines, we offer a broad range of biologics quality control assays, including:

  • Cell bank characterization
  • Plasmid and viral vector ID testing
  • Residual DNA and host cell protein testing
  • Compendial assays
  • Gene therapy drug substance and product release assays
  • Custom assay development, validation, and more

Ensure the Success of Your Biological Drug Development

Avance Biosciences is a world leading CRO providing CGMP/GLP compliant biological testing solutions supporting the biological drug development pipeline from discovery through manufacturing.

What We Do

Biopharmaceutical drug development requires extensive biological testing for raw material release, in-process quality control, and final product characterization to secure product safety and satisfy the regulatory requirements of the FDA and other regulatory agencies.

We offer CGMP/GLP-compliant assay development, assay validation, and sample testing services to ensure strict regulatory compliance and a smooth journey to market. Using ICH guidelines, we offer a broad range of biologics quality control assays, including:

  • Cell bank characterization
  • Plasmid and viral vector ID testing
  • Residual DNA and host cell protein testing
  • Compendial assays
  • Gene therapy drug substance and product release assays
  • Custom assay development, validation, and more
Avance

Our Comprehensive CGMP-Compliant Biologics Testing Solutions

We offer tailored services that provide you with a powerful way to address identity, stability, and safety concerns, satisfying the requirements of regulatory agencies worldwide.

Our Comprehensive CGMP-Compliant Biologics Testing Solutions

We offer tailored services that provide you with a powerful way to address identity, stability, and safety concerns, satisfying the requirements of regulatory agencies worldwide.

CAR-T

CAR-T and other gene or
cell therapy product release

  • Replication competent lentivirus (RCL) and vector copy number (VCN) testing

  • qPCR and ddPCR assays for integrated gene copy analysis

  • NGS amplicon sequencing for product characterization

  •  Potency and infectivity assays

  •  Transfection assay via single-cell NGS

  •  Transfection assay via colony picking and Sanger sequencing 

  • STEMvision™ for colony-forming unit (CFU) assays

DNA sequencing and residual host cell
DNA assays for product release

  • Sanger sequencing for plasmid drug products and viral vaccines

  • NGS for inverted terminal repeats (ITR), GC-rich, and other challenging constructs

  • cDNA sequencing and qPCR for multi-valent RNA vaccines

  • qPCR residual host cell DNA testing for protein drug products

Cell Bank

Cell bank and viral seed
characterization assays

  • Microbial assays for bacterial cell bank release, including identity, purity, stability, viability, and phage contamination

  • qPCR and ddPCR for plasmid copy number or inserted gene copy number

  • Sanger sequencing for plasmid and inserted gene sequence verification

  • Next-generation sequencing (NGS) for plasmid and viral genome confirmation

  • Restriction mapping for plasmid evaluation

  • Southern blots for integration site and inserted gene structure analysis

  • NGS for phage ID

CAR-T

CAR-T and other gene or cell therapy product release

  • Replication competent lentivirus (RCL) and vector copy number (VCN) testing

  • qPCR and ddPCR assays for integrated gene copy analysis

  • NGS amplicon sequencing for product characterization

  •  Potency and infectivity assays

  •  Transfection assay via single-cell NGS

  •  Transfection assay via colony picking and Sanger sequencing 

  • STEMvision™ for colony-forming unit (CFU) assays

DNA sequencing and residual host cell DNA assays for product release

  • Sanger sequencing for plasmid drug products and viral vaccines

  • NGS for inverted terminal repeats (ITR), GC-rich, and other challenging constructs

  • cDNA sequencing and qPCR for multi-valent RNA vaccines

  • qPCR residual host cell DNA testing for protein drug products

Cell Bank

Cell bank and viral seed characterization assays

  • Microbial assays for bacterial cell bank release, including identity, purity, stability, viability, and phage contamination

  • qPCR and ddPCR for plasmid copy number or inserted gene copy number

  • Sanger sequencing for plasmid and inserted gene sequence verification

  • Next-generation sequencing (NGS) for plasmid and viral genome confirmation

  • Restriction mapping for plasmid evaluation

  • Southern blots for integration site and inserted gene structure analysis

  • NGS for phage ID

Who We Are

A world leading CRO providing GMP/GLP compliant biological testing solutions supporting the biological drug development pipeline from discovery through manufacturing. Our team has decades of experience in supporting cell-based drug manufacturing. With our technical expertise, focus on a strong adherence to regulatory guidelines, and dedication to exceeding our client’s expectations, we provide creative solutions to assure your drug development success.

Meet With Our Experts Today

We are a team of dedicated scientists, and quality control professionals focused on meeting your needs and completing your challenging drug development and manufacturing projects. By partnering with us, you’ll benefit from collaboration with a scientific team with decades of experience designing, validating, and executing biological assays and tests for regulatory submission.

Have questions?

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.

SEND US A NOTE

Ready to get started?

Give us a little background on your needs and the goals of your project, and we’ll send a preliminary quote including: tasks, deliverables and a no-obligation cost estimate.

REQUEST A QUOTE

Our Customers Say…

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!

Partner

Dedication to Quality

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.

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Extensive Experience

Open Communication

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.

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Open Communication

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.

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Cutting Edge Science

Open Communication

Avance Biosciences’ GLP/GMP 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.

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