Pilot-Scale Studies, Scaling-Up, and Technology Transfer

Abstract

Pilot-scale and scaling-up studies are essential steps for assessing the practicality of any bioprocessing project. They can determine whether the project or venture is likely to succeed and can identify potential issues and problems that could arise before scaling up the project to larger industrial scales. This chapter discusses critical matters related to pilot-scale studies, scaling-up, and technology transfer. The chapter aims to create the basis for further discussion regarding crucial milestones from the pilot plant to necessary technology transfer for industrial application. The different characteristics and the time element are also mentioned to illustrate some of the finer points of scale-up and technology transfer. This chapter also touches on some operational aspects of the technology transfer and scale-up processes. It offers a systematic approach for negotiating them effectively, including a methodology designed to ease and accelerate transfer from one bioreactor to another.