Process characterization and viral clearance validation are pivotal studies in biopharmaceutical manufacturing, particularly for monoclonal antibodies (mAbs) produced in mammalian systems, which carry ...

Assessing the chemical makeup of a medical device as part of the safety evaluation can either be a blessing for manufacturers by shortening the time to market or entail some surprises, according to ...

Expertise in CMC (chemistry, manufacturing, and control) ensures the appropriate manufacture of a pharmaceutical or biologic by coordinating material characterization, formulation development, and ...