Monoclonal antibody manufacturing is advancing to boost efficiency, cut costs, and expand access, driven by innovation, demand, and the rise of biosimilars.
Antibody-drug conjugate manufacturing requires, among other things, unidirectional flow and air locks for people and materials. Facilities often lack these attributes.
A conversation with Brandi Stockton and Martin Heitmann
International Society for Pharmaceutical Engineering members developed this guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.
