Intertek, a quality and safety solutions provider, has launched cGMP compliant cell based assay services for biologic therapeutics in its European Centre of Excellence for Biopharmaceuticals at Manchester, U.K.
“With the addition of tailored cell based assays, Intertek now offers a comprehensive characterization service for biologic therapeutics,” said Ashleigh Wake, biotechnology team leader, Intertek.
The assays determine biological activity or potency by measuring the product’s physiological response and are important to product release and stability studies. They are applied in the analysis of biologics, biosimilars and a wide range of macromolecules including peptides, recombinant proteins, monoclonal antibodies, growth factors, hormones or cytokines.
“We will work with our clients to provide a fully validated cell based assay suitable for regulatory submission, one which performs reproducibly throughout the entire drug development process,” added Wake.
Cell based assay services from Intertek include method transfer, development and validation, release and stability testing, tracking and trending (for establishment and maintenance of assays for earliest identification of assay drift, ensuring reliable results over the assay’s lifetime) and end-point analysis.