Alphalyse Information

Alphalyse has pioneered the use of mass spectrometry analysis since 2002. Our scientists have completed over 5,000 protein characterization analyses, including forced degradation studies and over 400 LC-MS-based residual/host cell protein projects. Currently, we are the only CRO in the World certified to offer LC-MS-based MRM analysis under GMP for release testing. As a specialist contract research organization (CRO), we offer protein analysis services to support biopharmaceutical companies in developing and manufacturing patient-safe products such as mAbs, vaccines, recombinant proteins, and cell & gene therapies. You can count on us to work closely with you on developing well-characterized biologics by challenging and improving analysis methods using top-of-the-line mass spectrometry technology (LC-MS). Our comprehensive reports will allow you to carry out data-driven process development and regulatory documentation under ICH Q6B guidelines. Our services include analytical characterization of biopharmaceuticals, mass spectrometric peptide mapping, host cell protein analysis, and quantifying specific proteins in complex samples.