Trusted Bioassay Support & Potency Testing

Whether you’re working on biologics such as monoclonal antibodies, recombinant proteins or peptides, vaccines, oligonucleotides or gene therapies, the regulatory requirements are explicit – the biological activity or potency of a biopharmaceutical product must be established as a critical quality attribute (CQA). 

The challenge is related to the complexity in designing, optimising, and executing them. They involve living systems, nuanced method development, and require highly skilled analysts capable of consistently managing variable biological systems.

With decades of proven expertise, the Eurofins BioPharma Product Testing network of laboratories provides comprehensive support across all phases of product development, delivering robust, regulatory-aligned biological assays—validated and tailored to each product profile, development timeline, and strategic objectives.

Our full suite of services:

  • Custom assay development and optimisation
  • Method validation (based on ICH Q2 (R2)-compliant approaches) and transfer
  • Lot release and stability testing
  • Potency assay development and validation of cell & gene therapy products
  • Support for all Phases and commercial programmes

From building client-specific, ad hoc assays to adapting platform methods for novel biologics, our teams are equipped with the regulatory knowledge and scientific expertise required to deliver:

Cell-Based Assays

  • Cell proliferation
  • Cell survival/apoptosis
  • Reporter gene assay
  • ADCC, CDC, and ADCP
  • Cell migration
  • Cytokine release assay
  • Cell based ELISA
  • Flow Cytometry (FACS) cell-based assay

Binding Assays

  • ELISA
  • Electrochemiluminescence
  • Surface Plasmon Resonance (SPR)
  • Bio-layer Interferometry (BLI)
  • Flow Cytometry (FACS)

Our assay maintenance programmes and continued lifecycle management ensure validated methods remain robust and fit for purpose over time.

If your internal teams need added capacity or expertise to manage this demanding testing, Eurofins BPT provides the kind of end-to-end solution that has resulted in long-lasting client partnerships.