The Search for Process Intensification and Simplification: Alternative Approaches versus Current Platform Processes for Monoclonal Antibodies

Abstract Over the past 5–10 years, the need for the biopharmaceutical industry to produce and deliver even higher quantity and quality of mAbs to patients has highlighted and accelerated the need for process productivity and simplification. Process developers must carefully weigh the balance of maintaining a platform process that may become obsolete versus improvements to the platform process that increase throughput, aid in ease of manufacturing, or reduce cost of goods. At one extreme, a company may not be willing to evolve their platform, which risks obsolescence of its platform process and failure to meet market demand. At the other extreme is an aggressive culture of innovation which rapidly implements new technology before fully vetting the technology, putting the process at risk for batch failure, delays in regulatory approval, or worst case, compromise of patient safety.