The Intensified Design of Experiment (iDoE) approach has the potential to significantly reduce the time needed for process development and characterization. “We’ve proved iDoE on a 20 L scale and ...
Expertise in CMC (chemistry, manufacturing, and control) ensures the appropriate manufacture of a pharmaceutical or biologic by coordinating material characterization, formulation development, and ...
Process characterization and viral clearance validation are pivotal studies in biopharmaceutical manufacturing, particularly for monoclonal antibodies (mAbs) produced in mammalian systems, which carry ...