Potency Assay Development Services

Ensure regulatory success with custom-developed and validated potency assays designed to meet FDA IND/BLA requirements for cell and gene therapy products.

Avance Biosciences delivers tailored potency assay solutions under cGMP, supporting efficient therapeutic development and compliant product release.

Customized Assay Design

We understand that each therapeutic product is unique. Our team works closely with you to design customized potency assays tailored to your specific needs, ensuring an accurate evaluation of your product’s efficacy.

Method Optimization

Our scientists have extensive experience in optimizing complex assays. We carefully assess variables, including critical parameters, sample matrices, and analytical techniques, to develop robust and reproducible assays.

Reliable Bioanalytical Techniques

We employ a range of cutting-edge techniques, including flow cytometry, automated western blot, qPCR, ELISA, ddPCR, and NGS, to measure potency accurately. Our advanced instrumentation and rigorous quality control processes guarantee reliable and precise results.

Regulatory Compliance

We are well-versed in regulatory guidelines, such as those provided by the FDA, EMA, and ICH. Our assays are designed and qualified and/or validated to meet these requirements, ensuring the generation of data suitable for regulatory submissions.

Data Analysis and Reporting

Our team provides comprehensive data analysis and interpretation, delivering clear and concise reports. We ensure that you receive actionable insights and recommendations to support your decision-making process.

Why Choose Avance Biosciences?

Avance Biosciences offers unmatched scientific expertise, combining deep experience in assay development with a commitment to innovation in the biologics field. Our state-of-the-art facilities and advanced instrumentation support the execution of complex potency assays under rigorous quality standards. We deliver reliable, high-quality results on time to meet the demands of fast-paced drug development. Above all, we uphold the highest standards of confidentiality and data security to safeguard your sensitive information and intellectual property.

Our Customers Say…

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

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

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