Chapter 7 - Process Scale-up, Tech-Transfer, and Optimization

Abstract

In an engineering environment, experiments are often conducted to explore, estimate, or confirm. These experiments become the basis for ensuring quality of the product as the process is scaled-up. As a project progresses through appropriate clinical trials, a fortunate instance may arise in which the drug molecule may show promise and is therefore a candidate for further registration and commercialization at a larger scale. This stage in the project is very critical as the bioperformance of the drug is being better understood and significant resources are being expended to make it registration-ready. This is unfortunately the time at which the formulators and process engineers lose most of their flexibility to make adjustments to the formulation and/or process. Therefore, formulators should realize the restrictions that scale-up and tech transfer places on their product and should proactively work with their manufacturing team to address these limitations. In this chapter, some best practices for addressing scale-up issues are discussed.