Merck conclusionCONCLUSIONS Merck & Co., Inc. (West Point, PA, USA) has explored the compatibility of the microwave vacuum drying process with two different proteins and a live virus vaccine and observed that the process has the potential to be broadly applicable to the same product types that today rely on vial lyophilization. Using a lab-scale unit, our results demonstrate that MVD serves as one of the most rapid dehydration approaches that can reduce freeze-drying cycle time by ≥ 80%. Product critical quality attributes (CQAs) were found to be comparable between a lyo-dried and MVD sample for all cases studied in this report. This contrasts with standard vial freeze drying that is a slow batch drying process requiring a cycle time in the order of days, often requiring scale-up (i.e., capital) to multiple units in a given manufacturing facility and thus prompting the need for faster alternatives to pharmaceutical freeze drying. By virtue of its rapid drying, MVD has the potential to enable semi-continuous manufacturing, and our hope is that this work serves as a foundational prompt to develop a more optimized drying technology that enables exible manufacturing. The challenge ahead is to build upon the fundamental heat and transfer principles associated with MVD and lyophilization to eventually couple more effective heat transfer mechanism associated with radiative drying process with the optimal process controls obtained in lyophilization while maintaining compliance with the cGMP regulations. Such exible rapid cGMP drying, once established, would not only help reduce the overall operational costs but would also better serve our patient needs through on-demand manufacturing....(MVD = microwave vacuum drying)