Continuous Manufacturing for Pharmaceuticals
Innovations
The operational complexity and the challenges in obtaining high yields of pure enantiomers pose great challenges to the pharmaceutical industry. As a solution, the migration from batch to continuous manufacturing may enable efficient, viable, and sustainable processes.
Improvements
Continuous manufacturing (CM) has many positive attributes, e.g. real-time process variable control, integrated product quality monitoring, and process integration, that chemical engineers in process industries have implemented for decades.
Progress
By contrast, the pharmaceutical industry has focused on batch processing, driven by numerous factors including certain regulatory constraints and limitations of the typical development timeline.
Future
In recent years, the Food Drug Administration (FDA) and pharmaceutical companies have initiated a movement to change from batch processing to CM by creating advances in unit operations and process analytical technology (PAT) that can be implemented throughout the process.Prospects
To satisfy the FDA regulations and implement CM across the industry, some challenges associated with exothermic reactions, high temperatures and pressures, and toxic, reactive, corrosive, and explosive intermediates must be resolved. In the Allgeier lab, we aim to develop general solutions, impacting a range of innovative continuous flow unit operations for active pharmaceutical ingredients and intermediates. We apply fundamental understanding of reaction kinetics, reaction engineering and fluid phase behavior to optimize reactions and improve downstream processing operations.
The Continuous Manufacturing Team in the Allgeier Research Group - Spring 2019