Implementation of postlicensure process improvements in the biopharmaceutical industry can benefit patients and drug manufacturers alike. Here we demonstrate through a case study how a change to the cell culture medium and process can be taken from proof of concept through scale-up to demonstration of feasibility. We further illustrate the scope and complexity of implementing a change in commercial manufacturing to realize significant benefits such as increased production capacity over an existing legacy process.
The Importance of Postapproval Improvements
Drug development is a complex process, and related business drivers typically shift through a drug’s life cycle. Before market licensure, the emphasis is on ensuring product safety and efficacy during clinical trials in addition to speed to market (left). The need to lock a process in as soon as possible limits opportunities for optimization. As a consequence, process optimization and capacity improvements are often postlaunch activities performed when the scope of market demand and the competitive business environment are both better understood. After a product is launched, related business drivers shift toward cost of goods (CoGs) and ensuring supply to patients while maintaining product quality. After launch and throughout a commercial production life cycle, process optimization is performed within the strict regulatory and quality frameworks of biopharmaceutical products, of course.
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