One of the many lessons that the SARS-CoV-2 pandemic has taught the world is the vulnerability of supply chains. When factoring in wars, tit-for-tat tariffs, and safety recalls, an actionable plan needs to be in place to swiftly adapt to rapidly changing supply demands. In response, a call for more flexible manufacturing is desired to address such challenging geographic, economical, and political climates. One aspect of flexible manufacturing is the ability to quickly transfer product between manufacturing locations. When production of a specific product cannot meet supply additional manufacturing lines, not previously utilized for said product, could be implemented to meet the additional supply demand. One such instance where this procedure would have been extremely useful during the recall and subsequential lack of supply of baby formula in the United States, which resulted in the import of product from foreign entities. In the current practice of transferring between one manufacturing route, or site, to another, the procedure is to perform multiple designed experiments and perform statistical analysis on the results. While scientifically beneficial, practically this leads to significant waste in material with little to no actionable items. This methodical approach is not suited to respond to a crisis. Therefore, an approach is needed to focus on critical quality attributes of the existing drug product and methods in which to reproduce the key attributes. One step that is universal in making tablets is the compaction step. Whether it is roller compaction, wet granulation, direct compaction, batch manufacturing, or continuous manufacturing, a tablet press is utilized to bring punches together and compress the final blend into a desired thickness, shape, and mass. Therefore, if the material entering the dies of the press has the same properties (bulk packing, flow, etc.) similar tablet properties should be obtained for both processes. With this understanding, the research presented here is focused on how shearing of powder that occurs in different manufacturing lines can be utilized to generate blend with similar properties. Utilizing three different blenders and two different tablet press feed frames, an IR shear sensitive formulation was blended in three different manufacturing routes, under different shearing profiles, number of rotations, throughput, and RPM, to prove that the final product can be manufactured on different lines.
