Tailored cell-based bioassay or potency assays for biologics and biosimilars to meet the requirements of ICH Q6B and Good Manufacturing Practice (GMP)
GMP Cell-based assays, or potency assays, determine the biological activity of a biologic by measuring the product’s physiological response and play an important role in product release testing and biopharmaceutical stability studies. Cell-based assays determine the relative potency of a product by comparing the biological response, related to its mode of action, with a control preparation (USP, WHO or in-house reference standards) in order to determine a product’s efficacy and ability to achieve a defined biological effect.
A biological assay or potency assay is required to determine the biological activity of the product to meet regulatory submissions and should be validated to GMP for use in lot release testing. These are complex cell-based assay methods which necessitate expertise in method development and validation.
We are experienced in method development, method transfer, method validation to GMP standards and conducting routine potency assays using cell migration, ligand binding, ELISA, cell signalling, cell proliferation and inhibition of proliferation, binding assays or competitive assays approaches.
Our experts will work closely with you to provide a fully validated potency assay your biological drug substance and/or drug product, suitable for regulatory submission, which will perform reproducibly throughout the whole drug development process.
GMP Cell-based Assays or Potency Assay Applications
Our potency testing services are routinely deployed in biopharmaceutical stability testing and product release testing. In addition, we can also apply our cell-based bioassay services to support you in gap analysis (for optimisation and transfer of assays), tracking and trending (for establishment and maintenance of assays to identify assay drift early on to ensure reliable results over the assays lifetime), range finder studies to investigate assay parameters or for statistical evaluation using fully validated software packages.
Further cGMP Potency Applications:
Potency Testing for Biosimilar Monoclonal Antibodies
Our biosimilar testing experts perform detailed determination of relative potency through side-by-side analyses of an appropriate number of lots of the proposed biosimilar product and the reference product using accepted mode of action approaches such as antibody-dependent cell-mediated cytotoxicity (ADCC) or complement-dependent cytotoxicity (CDC).
Alongside potency or biologic activity assessment, we can provide extensive information on the product structure from the primary structure through to higher-order structure, post-translational modifications and glycosylation studies. Our physicochemical property determination services include molecular weight and electrophoretic, chromatographic and spectroscopic profiles.
Our expertise in complex method development and validation, in particular for cell-based assays, can give you detailed insight into your product, helping to accelerate your development process.
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