Ensure the Success of Your Biological Drug Discovery and Development

Avance Biosciences is a world-leading CRO providing advanced and customized assay solutions to facilitate your biotherapeutic products’ research and development.

What We Do

Biopharmaceutical drug discovery and development requires a solid understanding of the therapeutic target, conformation and characterization of drug candidates, and customized solutions for pre-clinical and clinical testing.

We offer a broad range of assay development services, including assay design, assay validation, sample testing, and technology transfer under GLP compliance to support IND-enabling and clinical studies. With decades of experience helping gene and cell therapy companies, Avance Biosciences has the expertise and track record to assist you with your biological drug discovery and development.

Our assays use the latest biological assay techniques and technologies, including:

Assay Techniques

Ensure the Success of Your Biological Drug Discovery and Development

Avance Biosciences is a world-leading CRO providing advanced and customized assay solutions to facilitate your biotherapeutic products’ research and development.

What We Do

Biopharmaceutical drug discovery and development requires a solid understanding of the therapeutic target, conformation and characterization of drug candidates, and customized solutions for pre-clinical and clinical testing.

We offer a broad range of assay development services, including assay design, assay validation, sample testing, and technology transfer under GLP compliance to support IND-enabling and clinical studies. With decades of experience helping gene and cell therapy companies, Avance Biosciences has the expertise and track record to assist you with your biological drug discovery and development.

Our assays use the latest biological assay techniques and technologies, including:

Assay Techniques

Applications

We offer tailored GLP-compliant assay solutions in several application areas, driving your discovery and development efforts forward with reliable, trusted results.

  • DNA and RNA biodistribution studies

  • Gene expression studies

  • Protein studies with ELISA and western blot

  • CRISPR on-/off-target evaluation

  • Gene editing translocation evaluation

  • Single-cell amplicon NGS assays

  • NGS integration analysis for gene editing and gene therapy

  • Vector copy number (VCN) analysis for inserted genes

  • Colony forming unit assays (CFU)

  • Viral titer determination

  • Custom assay design and validation

Avance

Our Approach To Your Project

We’re here to advance your biological discovery and development. We do it with solid science, strict regulatory compliance, and an experienced team to streamline the process.

Our Approach To Your Project

We’re here to advance your biological discovery and development. We do it with solid science, strict regulatory compliance, and an experienced team to streamline the process.

Project Management

  • Collaboration with you to develop and qualify assays, and perform sample testing

  • Dedicated project manager, senior scientist, and study director to lead your project

  • Regularly scheduled project check-in meetings to review data and discuss next steps

  • Flexible structure to accommodate changing requirements

  • Sound scientific approach and methods

Assay Development

  • Robust assay design

  • Specificity, sensitivity, accuracy, and precision determination

  • Development of appropriate control and reference samples

  • Advanced development and pre-qualification of all parameters associated with qualification and validation to fully characterize assay performance

Qualification and Validation

  • Follow FDA/ICH guidelines for assay qualification and validation

  • Parameters include specificity, sensitivity, precision/accuracy, robustness, extraction efficiency, and more

  • Mutually agreed on pass/fail criteria determined in advanced development

  • QA reviews all data, test plans, and final report

  • Ability to validate NGS data analysis pipeline

Project Management
Design

Project Management

  • Collaboration with you to develop and qualify assays, and perform sample testing

  • Dedicated project manager, senior scientist, and study director to lead your project

  • Regularly scheduled project check-in meetings to review data and discuss next steps

  • Flexible structure to accommodate changing requirements

  • Sound scientific approach and methods

Assay Development

  • Robust assay design

  • Specificity, sensitivity, accuracy, and precision determination

  • Development of appropriate control and reference samples

  • Advanced development and pre-qualification of all parameters associated with qualification and validation to fully characterize assay performance

Qualification and Validation

  • Follow FDA/ICH guidelines for assay qualification and validation

  • Parameters include specificity, sensitivity, precision/accuracy, robustness, extraction efficiency, and more

  • Mutually agreed on pass/fail criteria determined in advanced development

  • QA reviews all data, test plans, and final report

  • Ability to validate NGS data analysis pipeline

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 biological drug development and 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. When you partner with Avance Biosciences, you gain a CRO partner that is creative, collaborative, and dedicated to sound science with a focus on your specific regulatory requirements.

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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