Sphera and global healthcare company Baxter share insights and best practices on Quality by Design to engineer risk out of your processes. The desired state is to attain ‘a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight.’*. However, the path to get there is not without difficulties. As more complexities are introduced into the system, such as drug-device combinations and advanced coating materials, a risk based approach to design and manufacturing has become essential.