Potency testing is an essential part of developing cellular and gene therapy (CGT) products. The US Food and Drug Administration (FDA) requires sponsors for Investigational New Drug (IND) and Biologics License Application (BLA) to provide in vitro or in vivo data to demonstrate the potency of the drug product. As such, potency testing plays a critical role in the development and approval of CGT products.

At Avance Biosciences™, we provide comprehensive services to assist our clients in advancing their therapeutic drug development and meeting FDA requirements efficiently and effectively. We use case-by-case approach to develop, qualify, or validate custom potency assays in accordance with current Good Manufacturing Practice (cGMP) regulations, ensuring that they comply with the necessary standards for GMP product release.

Services Provided: 

  • Custom Potency Assay Development – Tailored to your specific requirements, our potency assay development services ensure that your CGT products are thoroughly evaluated.

  • Potency Assay Validation under GMP – Our potency assay validation process ensures that your assays meet regulatory standards and deliver accurate results.

  • Sample Potency Testing under GMP – We offer comprehensive potency testing services to assess the effectiveness of your therapeutic products.

  • Client Potency Assay Technology Transfer

  • Cell-Based Potency Assays – We specialize in designing and validating cell-based potency assays to evaluate the potency of your CGT products.

  • Bioactivity Assays – Our expertise in bioactivity assays ensures that your products are tested thoroughly for their intended biological activity.

Our team excels in developing cell-based potency assays that adhere to the highest standards of quality and compliance. We understand the critical role that bioactivity assays play in CGT product development, and we are committed to providing the expertise you need to succeed.

Our talented scientific team has extensive expertise on a broad range of technologies to support clients’ needs, including cell biology, microbiology, virology, and state-of-the-art analytical tools.

Analytical Capabilities:

  • Mammalian cell culture

  • Microbial cell culture

  • Next-generation sequencing (NGS)

  • Digital droplet polymerase chain reaction (ddPCR)

  • Quantitative polymerase chain reaction (qPCR)

  • Enzyme-linked immunosorbent assay (ELISA)

At Avance Biosciences™, we understand the importance of precision and reliability in potency assays and potency testing. Our commitment to excellence extends to every aspect of our work, from potency assay development to potency assay validation and bioactivity assays.

We pride ourselves on our open communication and quick turnaround times. If you are interested in learning more about our potency testing services, please do not hesitate to contact us by email at sales@avancebio.com or by phone at (713) 849-3380.

Potency testing is an essential part of developing cellular and gene therapy (CGT) products. The US Food and Drug Administration (FDA) requires sponsors for Investigational New Drug (IND) and Biologics License Application (BLA) to provide in vitro or in vivo data to demonstrate the potency of the drug product. As such, potency testing plays a critical role in the development and approval of CGT products.

At Avance Biosciences™, we provide comprehensive services to assist our clients in advancing their therapeutic drug development and meeting FDA requirements efficiently and effectively. We use case-by-case approach to develop, qualify, or validate custom potency assays in accordance with current Good Manufacturing Practice (cGMP) regulations, ensuring that they comply with the necessary standards for GMP product release.

Services provided: 

  • Custom Potency Assay Development – Tailored to your specific requirements, our potency assay development services ensure that your CGT products are thoroughly evaluated.

  • Potency Assay Validation under GMP – Our potency assay validation process ensures that your assays meet regulatory standards and deliver accurate results.

  • Sample Potency Testing under GMP – We offer comprehensive potency testing services to assess the effectiveness of your therapeutic products.

  • Client Potency Assay Technology Transfer

  • Cell-Based Potency Assays – We specialize in designing and validating cell-based potency assays to evaluate the potency of your CGT products.

  • Bioactivity Assays – Our expertise in bioactivity assays ensures that your products are tested thoroughly for their intended biological activity.

Our team excels in developing cell-based potency assays that adhere to the highest standards of quality and compliance. We understand the critical role that bioactivity assays play in CGT product development, and we are committed to providing the expertise you need to succeed.

Our talented scientific team has extensive expertise on a broad range of technologies to support clients’ needs, including cell biology, microbiology, virology, and state-of-the-art analytical tools.

Analytical capabilities:

  • Mammalian cell culture

  • Microbial cell culture

  • Next-generation sequencing (NGS)

  • Digital droplet polymerase chain reaction (ddPCR)

  • Quantitative polymerase chain reaction (qPCR)

  • Enzyme-linked immunosorbent assay (ELISA)

At Avance Biosciences™, we understand the importance of precision and reliability in potency assays and potency testing. Our commitment to excellence extends to every aspect of our work, from potency assay development to potency assay validation and bioactivity assays.

We pride ourselves on our open communication and quick turnaround times. If you are interested in learning more about our potency testing services, please do not hesitate to contact us by email at at sales@avancebio.com or by phone at (713) 849-3380.

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Our Customers Say…

Avance Biosciences™ (AB) has delivered the Sequencing data in a record time. Very impressive! We have benefited from AB’s hard work and are very grateful for that. AB team should feel proud of themselves. We thank AB team for their support and contributions, much appreciated.

Head of Quality Control, Microbial Manufacturing Service, California

Your team met the timelines we needed and did exceptional technical work. I will definitely make my management aware that Avance is a very capable partner for our bioanalytical needs.

Bioanalytical Senior Project Manager,  California

My experience with Avance has been nothing but positive… I will keep sending work your way as I appreciate the attention your team provides and Avance’s creative technical team. See you soon.

Director Individualized Medicines,  California

Avance has been the ideal partner in helping Mission Bio and our client,… be the first in the world to GMP qualify our single cell % transduction assay for a lentiviral gene therapy product. Excellent execution on the part of the Avance team. We look forward to more collaborations in the future.

Senior Director, Cell & Gene Therapy Business,  California

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!

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Dedication to Quality

Dedication To Quality

The Avance Biosciences™ team is committed to strict adherence to GLP and CGMP regulations enacted by the US, European, Japanese, and other international regulatory agencies.

Extensive Experience

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.

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.

Cutting Edge Science

Open Communication

Avance Biosciences™’ GLP/GMP compliant genomic and microbial assays make use of the advanced technologies including real-time PCR, digital PCR, Sanger sequencing, next generation sequencing, and more.