Monoclonal antibody manufacturing is advancing to boost efficiency, cut costs, and expand access, driven by innovation, demand, and the rise of biosimilars.
The United States Pharmacopeia is overhauling general chapters to align them with current industry standards. One scientist on the project helps us unpack the changes.
Here are practical tips to build validated, transparent, and auditable AI systems that align with GxP principles, paving the way for smarter and more resilient manufacturing processes.
