Cell-based and Potency Assay Services
Potency testing is a critical component in the development of biologics and other therapeutic products. The U.S. Food and Drug Administration (FDA) requires sponsors submitting Investigational New Drug (IND) and Biologics License Applications (BLA) to provide robust in vitro and/or in vivo data demonstrating the biological activity and effectiveness of the drug product. As a result, potency testing is central to both regulatory approval and product development, particularly for advanced modalities such as cell and gene therapies (CGT), mRNA therapeutics, vaccines, monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), and other large molecule biologics.
Potency Assay Services
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 Applications (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.
Built Around Your Product’s Actual Mechanism of Action
A single standardized bioassay can confirm your product does something, it often can’t confirm it’s doing the right thing, for the right reason. Avance builds potency strategies around your product’s actual mechanism of action, combining a functional readout with orthogonal molecular and protein-expression measurements so you can show regulators not just that your therapy works, but why.
Our Expertise
At Avance Biosciences, we offer comprehensive potency testing services designed to support therapeutic development and help clients meet regulatory expectations with confidence. Using a tailored, case-by-case approach, we develop, qualify, and validate custom potency assays in alignment with current Good Manufacturing Practice (cGMP) requirements, ensuring suitability for GMP product lot release, stability testing, and comparability studies.
Our team brings extensive experience in assay development, validation, and sample testing across a wide range of modalities, including gene-edited cell therapies, mRNA/LNP therapeutics, LNP-based vaccines, engineered bacterial vaccines, advanced delivery systems, large molecule biologics, and viral products.
Our Potency Assay Services
Potency work rarely starts and ends in the same place, we support programs anywhere on this path, from a first mechanism-of-action study to routine GMP release.
Custom potency assay development
Client potency assay technology transfer
Assay qualification or validation under GMP
Sample testing under GMP
Why Choose Avance Biosciences
Mechanism-first Assay Design
We start from your product’s mechanism of action, not a template assay, identifying which functional and orthogonal readouts actually represent how your product works, then designing the assay matrix around that, not the other way around.
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.
Portfolio of Analytical Techniques
We employ a range of cutting-edge techniques, including flow cytometry, automated western blot, qPCR, ELISA, ddPCR, and NGS, deployed together as a matrix, not a menu, so each readout confirms a different piece of your product’s mechanism of action.
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.
Independence
Avance is an independent analytical CRO. We develop and run your potency strategy without tying it to a particular manufacturing platform or provider, which matters if you work with a separate CDMO, anticipate a manufacturing-site transfer, or need one consistent analytical partner across a comparability or stability program.
Direct Scientist Access
You work directly with the scientists designing and running your assay, not a layer of account management between you and the science.
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.
Technical Information
Avance Biosciences developed and compared NGS and ddPCR-based potency assay platforms for a client’s LNP gene-editing drug product, screening candidate cell lines and dose ranges to establish a reproducible, cross-validated readout method.
Avance Biosciences developed a cell-based NGS assay to characterize on- and off-target gene-editing activity for a client’s LNP drug product, comparing editing at both loci across single-dose and repeated low-dose exposure to support its nonclinical characterization program.
This case study details how Avance Biosciences qualified an LC-MS/MS potency assay for a lentiviral gene therapy vector, measuring percent metabolite reduction in transduced patient-derived cells. The method met precision, assay performance, and system suitability criteria across two analysts and two days under a pre-approved cGMP protocol...
This case study explores a dual-platform potency assay strategy for multivalent LNP-mRNA vaccines, combining ELISA and flow cytometry to assess both mRNA expression and delivery performance. It highlights key analytical challenges and provides practical insights to support robust, scalable, and regulatory-ready potency testing.
Download our technote, Successful Development of Cell-based Potency Assays, to explore the essential role of potency assays in evaluating the biological activity of complex therapeutics, including cell and gene therapy products. This comprehensive guide draws on our extensive experience designing and validating custom potency assays, offering practical insights into assay formats, MOA selection, and relative potency determination...
Regulatory Guidance
This draft guidance provides recommendations for developing assays to evaluate potency as part of a potency assurance strategy for active immunotherapy products (ACTIMPs), including peptide- and protein-based ACTIMPs that are not cellular or gene therapy products. It supplements FDA's December 2023 draft guidance "Potency Assurance for Cellular and Gene Therapy...
On December 28, 2023, FDA announced the availability of the draft guidance, Potency Assurance for Cellular and Gene Therapy Products. For a high-level overview of this guidance document, please view this recorded webinar featuring Dr. Matthew Klinker, Cell Therapy Branch 2 Chief, Office of Cellular Therapy and Human Tissues, Office...
The purpose of this guidance is to provide to sponsors recommendations that assist in the development of monoclonal antibodies (mAbs) and other therapeutic proteins that directly target viral proteins or host cell proteins mediating pathogenic mechanisms of infection. A critical quality control measure for these products is the development and...
We, FDA, are issuing this guidance to provide you, manufacturers of cellular and gene therapy (CGT) products, with recommendations for developing tests1 to measure potency.2 These recommendations are intended to clarify the potency information that could support an Investigational New Drug Application3 (IND) or a Biologics License Application4 (BLA). Because...
