Is next level Multi-Attribute Analysis by LC-MS becoming the new regulatory standard?

If so, we are prepared. We recently expanded our lab space, now home to our newest acquisition: the Orbitrap Exploris 240 LC-MS.

LCMS (Liquid Chromatography Mass Spectrometry) is rapidly emerging as a preferred technology for Multiple-Attribute Analysis (MAA), especially for complex biologics. By consolidating into a single, information-rich run what previously required multiple chromatographic methods (RP, IEX, HIC, etc.), LC-MS provides detailed molecular insights, enabling monitoring of critical quality attributes.
A trend today, a potential regulatory standard tomorrow? ProJect Pharmaceutics is already leading the way with next-generation technology on board!
ProJect Pharmaceutics is a CRO specialized in formulation and lyophilization process development for injectable drug products. Our newest team member, the Orbitrap Exploris 240 LC-MS (by Thermo Fisher https://documents.thermofisher.com/TFS-Assets/CMD/brochures/br-73410-ms-orbitrap-exploris-240-br73410-en.pdf), has moved into our expanded laboratory space, enabling next-level analytics for formulation and process development of injectable drug products, such as:

  • mAb and ADC characterization
  • Native DAR determination by SEC-MS
  • Drug-load-distribution by PepMap
  • Detection of degradation (fragments, side chain modifications, hydrolysis)
  • Analysis of mAb glycosylation
  • Impurity analysis (e.g. HCP)

Partner with us to unlock faster, deeper, and more precise analytical insights.

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