Alphalyse
Biotechnology ResearchSouth Denmark, Denmark11-50 Employees
Alphalyse is a biotechnology research contract organization focused on analytical characterization of biopharmaceuticals. Based in Odense, Denmark, the company offers mass spectrometry–driven protein analysis services aimed at supporting development and manufacturing for products such as monoclonal antibodies, vaccines, recombinant proteins, and cell and gene therapies. With a track record of thousands of protein characterizations and hundreds of LC-MS–based residual or host cell protein projects, Alphalyse positions itself as a specialized partner for data-driven process development and regulatory documentation under ICH Q6B guidelines. The firm emphasizes close collaboration with clients to challenge and refine analytical methods, delivering comprehensive reports to aid release testing and quality control, including GMP-compliant LC-MS–MRM analysis as a unique capability. Notable recent developments include a collaboration with 89bio to develop and validate an LC-MS–based assay with very low detection limits.
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