Process Characterization

A structured, statistical approach for evaluating parameter interactions and process robustness that identifies potential risks to quality early.

Comprehensive impurity profiling to detect, identify, and quantify these species with high sensitivity and specificity. Our integrated analytical approach combines LC-MS with orthogonal techniques to deliver detailed characterization across a wide range of impurity types and biological matrices. This includes host cell protein detection, sequence variant identification, and characterization of low-level and trace impurities.

Evaluate manufacturing parameters systematically to identify process variables and raw material characteristics that may affect critical quality attributes, including physical, chemical, biological, or microbiological properties.

Qualified, small-scale representations of development processes are used to evaluate process performance, troubleshoot, and optimize parameters.