Intertek has launched cGMP-compliant cell-based assay services for biologic therapeutics at its European Centre of Excellence for Biopharmaceuticals in Manchester, UK. The cell-based assay services include: method transfer, development and validation, release and stability testing, tracking and trending, and end-point analysis.

“With the addition of tailored cell based assays, Intertek now offers a comprehensive characterization service for biologic therapeutics,” said Ashleigh Wake, Intertek biotechnology team leader. “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.”

“The launch of cell based assays in Europe further demonstrates Intertek’s commitment to support developers and producers of biopharmaceuticals with essential and advanced testing services,” said Dr. Andrew Swift, executive vice president, Intertek Chemicals and Pharmaceuticals, “Our wide technology base and experience in characterizing these complex drug substances and products positions Intertek well to support biologics development worldwide.”