Biologics CMC PIP

A Therapeutics client was in a phase III clinical trial and in need of a CMC/Quality specialist to assist with CMO oversight. Bioethic deployed a local consultant who was able to be onsite in Saint Louis, MO, for the cGMP upstream and downstream drug substance manufacturing process of a monoclonal antibody. Our support included overseeing cGMP production as well as process characterization studies and BLA preparedness activities.