GMP LC-MS Alphalyse is uniquely certified to offer LC-MS-based MRM analysis under GMP for release testing, presenting a compelling selling point for biopharma companies seeking compliant, release-validated analytics.

Mass Spec Leader With over 5,000 protein characterization analyses and 400+ LC-MS residual/host cell protein projects, Alphalyse demonstrates deep mass spectrometry expertise ideal for rigorous biopharma development, QC, and regulatory support.

HCP & Impurity Focus Strong track record in host cell protein analysis and impurity profiling, including orthogonal MS methods, positions Alphalyse as a strategic partner for risk mitigation and quality assurance in biologics manufacturing.

Recent Collaborations Recent partnership with 89bio and ongoing expansion of MS-based assays indicate growth and potential for joint development programs in liver, cardiometabolic, and gene therapy spaces.

Growth & Availability Smaller CRO profile (11-50 employees) combined with high-end capabilities suggests agility for early- to mid-stage projects, making Alphalyse a strong fit for fast-moving biotech startups needing trusted analytical support.