• Cross‐scale quality assessment of a mechanistic cation exchange chromatography model

    10 days ago - By Wiley

    Abstract
    Cation exchange chromatography is an essential part of most monoclonal antibody purification platforms. Process characterization and root cause investigation of chromatographic unit operations are performed using scale down models. SDM chromatography columns typically have the identical bed height as the respective manufacturing‐scale, but a significantly reduced inner diameter. While SDMs enable process development demanding less material and time, their comparability to manufacturing‐scale can be affected by variability in feed composition, mobile phase and resin properties, or...
    Read more ...