In biopharmaceutical production, a thorough understanding of analytical processes and target molecules is essential for ensuring patient safety, as well as maintaining consistent and reliable product quality. Mass spectrometry (MS) represents a powerful toolbox to assess this knowledge and partially even compensates the need for a bundle of methods covering different analytical parameters due to its highly versatile applications. While mass spectrometry is often applied in the developmental phase, its use in biopharmaceutical routine testing is often hampered since requirements for specialised knowledge and GMP compliance are significant hurdles.

At Richter BioLogics, a leader in the microbial Contract Development and Manufacturing Organisation (CDMO) space, these hurdles were taken, opening the way to support development, production and release of biopharmaceutical products at multiple levels with an ESI-TOF (Electrospray Ionisation – Time Of Flight) based LC-MS (Liquid Chromatography-MS) system as a single device, beginning with characterisation of upstream process components up to GMP compliant release testing of large biomolecules.

The implemented ESI-TOF LC-MS system thus covers a wide range of applications over the whole product lifecycle, providing additional benefits to complete the analytical portfolio.