Fidelio Capital has acquired a majority stake in Alphalyse, a fast-growing Danish contract research organization specializing in GMP-validated liquid-chromatography mass-spectrometry (LC-MS) assays for host-cell-protein (HCP) impurity testing in biologic drugs. The founders of Alphalyse will retain a significant shareholding in the partnership, which aims to expand capacity, accelerate international growth, and establish the company as the global reference in biologic HCP impurity analysis.
Timing Aligns with Industry Shift
The partnership comes at a pivotal 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.
This technological shift has been underlined by the new U.S. Pharmacopeia (USP) General Chapter 1132.1 and was a central topic at recent discussions at the BEBPA Host Cell Protein Conference, where the transition from ELISA to LC-MS was front and center.
Comprehensive Development Support
Alphalyse already supports customers at every development stage, from discovery to commercial release, with quantitative, reproducible HCP data that de-risks regulatory submissions and shortens development timelines. The company's GMP-validated assays are fully aligned with the new USP chapter, positioning it to scale rapidly and set a new industry standard for HCP impurity analysis worldwide.
"Demand for precise insights into HCP impurities is growing quickly as biologics pipelines continue to expand," said Thomas Kofoed, PhD, Co-founder & CEO of Alphalyse. "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."
Strategic Growth Platform
Theodor Bonnier from Fidelio Capital highlighted the strategic opportunity: "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."
The acquisition positions Alphalyse to capitalize on the growing demand for advanced HCP impurity testing as the biologics industry continues to evolve and regulatory requirements become more stringent.
