Potency & QC Lot-release Testing Solutions

Functional, MOA-based Bioassays with Superior Lot-to-lot Reproducibility

Cell-based potency assays are critical tools to measure the efficacy of a drug during stability and potency testing. Potency assays begin early in drug development to measure the biologic therapeutic's intended biological effect and mechanism of action (MOA). Quality control (QC) lot-release testing, intended for late-stage drug release programs, involves assays that ensure consistency with high lot-to-lot reproducibility. Because drug discovery and development are time-consuming, complex, and expensive, implementing a physiologically relevant assay platform from early development through late-stage drug release programs, such as QC lot release, can be highly valuable.

Phase-Appropriate Bioassays for Potency and QC Lot Release

Eurofins DiscoverX^® develops qualified, MOA-reflective cell-based assays (bioassays) that are phase-appropriate and meet the requirements of specific therapeutic development stages, including potency and QC lot-release testing. These robust and highly sensitive bioassays provide reproducible and quantitative results. They are derived from stable cell lines and use a simple, homogeneous (no wash) thaw-and-use approach that alleviates assay passage-to-passage variability associated with cells derived from continuous cell culture. Packaged with ready-to-use cryopreserved cells, plates, and all the reagents and documents needed, Eurofins DiscoverX bioassay kits offer the ideal solution for your therapeutic development programs. These kits are rigorously tested to meet ICH (International Council for Harmonization) requirement guidelines and qualified with marketed biologic drugs or reference standards, allowing you to confidently de-risk your potency testing program, support the documentation expectations of regulatory submissions, and accelerate your therapeutic development timelines.