Alphalyse, a Danish contract research organisation (CRO) that has developed GMPvalidated liquidchromatography massspectrometry (LCMS) assays for hostcellprotein (HCP) impurity testing in biologic drugs, has announced that Fidelio Capital has acquired a majority stake in the company.
Alphalyse
Alphalyse’s founders will retain a significant shareholding, establishing an ambitious partnership aimed at expanding capacity, accelerating international growth, and establishing Alphalyse as the global reference in biologic HCP impurity analysis.
Thomas Kofoed, PhD, cofounder & CEO, Alphalyse said: “Demand for precise insights into HCP impurities is growing quickly as biologics pipelines continue to expand. Fidelio’s operational expertise and global network will allow us to increase our capacity and international footprint, ensuring developers and manufacturers have the data that regulators now expect from day one.”
The partnership comes at an exciting moment for the biologics market as the drug pipeline – particularly complex modalities – continues to expand and the limitations of legacy ELISA technology become increasingly clear. LC-MS is emerging as the method of choice for drug developers and manufacturers seeking deeper process insight and stronger regulatory compliance, a trend underlined by the new U.S. Pharmacopeia (USP) General Chapter 1132.1 and recent discussions at the BEBPA Host Cell Protein Conference, where this shift was front and centre.
Alphalyse already supports customers at every development stage, from discovery to commercial release, with quantitative, reproducible HCP data that derisks regulatory submissions and shortens development timelines. Its GMPvalidated assays are fully in line with the new USP chapter, positioning the company to scale rapidly and set a new industry standard for HCP impurity analysis worldwide.
Theodor Bonnier, Fidelio Capital said: “Alphalyse operates in an exciting high-growth segment undergoing a structural shift from ELISA to LC-MS. We are impressed by the highly automated, scalable platform the team has built and look forward to supporting their ambitious international expansion.”