Bioassay and Potency Testing

Bioassay and Potency Testing

Development of bioassays for batch release testing are a vital part of biologic drug product development. They are required to ensure the quality control of proteins, monoclonal antibodies (mAbs) or biosimilars. Once established, these assays are used to perform release testing to determine the purity, concentration, identity, safety and ensure consistency of the final drug or chemical product.

We can work with you on both the early assay development and validation to then convert those established assays to perform batch release testing under GMP.

We offer the following full value chain service from development to validation and routine testing:

Potency Assays

  • GMP potency assays of biologicals
  • Cell based and in vivo potency assays

Binding and Neutralization Assays

  • Binding Assays
  • Neutralisation AB-Assays
  • ADCC and CDC
  • Primary Blood Cell Assays

GLP Tox, Safety & in-Chemico Assays

  • Pharmacokinetics
  • HPLC
  • Focus areas include:
    • Pharmaceuticals
    • Chemicals
    • Cosmetics

Example assays that we have developed as routine assays:

Our team has over 20 years of experience in assay development and GMP testing.  These services are performed by Reaction Biology’s subsidiary Bioassay GmBH

Quality Management

The assay development and testing is performed under strict quality management and operated following current GLP, GMP and FDA guidelines. The site has obtained regulatory certifications:

  • GLP Certificate 2021
  • GMP Certificate 2021
  • FDA Registration Certificate 2014


Contact us to learn more about our GMP bioassay and potency testing services: 

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