Bioassays for Biologics

Ready-to-use, Cell-based Assays for Biologics Therapeutic Development, Including Characterization, MOA Confirmation, NAbs Detection, Stability Studies, and Potency Testing

Bioassays are analytical methods used to measure a drug's biological activity or potency using a biological system representing the mechanism of action (MOA) of that drug. Eurofins DiscoverX® offers an extensive portfolio of cell-based, mechanistically-relevant bioassays optimized and qualified using ICH (International Council for Harmonization) guidelines with marketed innovator biologic drugs or reference standards. These robust, quantitative, ready-to-use cell-based assays use a simple, homogeneous protocol. They are easily implemented for characterization, potency measurement, neutralizing antibodies (NAb) detection, stability studies, and many other additional applications to interrogate biological functions and accelerate your biologics development program from discovery to post-market QC lot-release testing.

Bioassays are ideal for determining drug potency and stability using a simple, homogeneous protocol that reflects the drug’s clinical MOA. These rapid cell-based assays bypass the need for expensive and time-consuming cell culturing or assay development, reducing timelines and errors.

Product Highlights
  • Biologically Relevant – MOA-reflective, functional assays for monitoring and testing of biologic therapeutics
  • Qualified – Qualified with marketed biologic drugs or reference standards using ICH guidelines
  • Robust & Reproducibility – High intra- & inter-lot reproducibility with assay linearity for stability & potency testing in QC lot release applications
  • Simple Protocol, Fast Results – Automation friendly, homogeneous protocol amenable to implementation in multiple labs & high-throughput format for increased efficiency

Consider Eurofins DiscoverX’s custom development capabilities for custom cell lines, assays, & enzyme development.

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Products

Bioassays are ready-to-use cell-based assay kits with a simple, homogenous protocol and are provided as qualified or target-based. These bioassay kits deliver results in less than a day, enabling implementation in QC lot-release programs and transfer across multiple testing sites globally. Qualified bioassays have been optimized for their respective originator drug or reference standard, and can easily reduce assay development timelines by over 12 months. Ready-to-use target-based or MOA-based bioassays are optimized with a reference ligand. These assays can be readily implemented in development programs for biologic drug candidates that use the same MOA or specific target and can be further optimized and qualified with the clinical drug candidate.