An equipment selection methodology for continuous manufacturing of small-molecule drugs
Author(s)Peng, Kevin,S. M.Massachusetts Institute of Technology.
Massachusetts Institute of Technology. Department of Chemical Engineering.
Sloan School of Management.
Leaders for Global Operations Program.
Richard D. Braatz and Roy E. Welsch.
MetadataShow full item record
Flexible, modular, continuous manufacturing small-scale plants (MCSPs) for small-molecule drugs have been recognized as potential safe and economical solutions for pharmaceutical manufacturing. However, among the variety of equipment technologies required for an MCSP platform, there are only a few technologies that have publicly available methodologies for equipment selection. In this study, a new method and tool for computer-assisted equipment selection was developed, which use key engineering correlations and design criteria to match off-the-shelf equipment with the synthesis processes of interest. Furthermore, the tool allows simultaneous equipment selection for multiple synthesis processes to allow the identification of the most flexible MCSP assets. The long-term goal of this tool is to encompass the entire span of technologies that could be used in an MCSP skid and to serve as a communal storage location for vendor-available equipment information to facilitate collaboration and design of a mainstream continuous manufacturing (CM) system. This methodology was applied to equipment selection for the continuous manufacturing of an actual Amgen small-molecule drug substance (API) as a case study. The results from this study showed that the new tool can improve the speed at which equipment is selected and can aid the process developer in decision-making for choosing the most suitable CM asset.
This electronic version was submitted by the student author. The certified thesis is available in the Institute Archives and Special Collections.Thesis: S.M., Massachusetts Institute of Technology, Department of Chemical Engineering, 2019, In conjunction with the Leaders for Global Operations Program at MITThesis: M.B.A., Massachusetts Institute of Technology, Sloan School of Management, 2019, In conjunction with the Leaders for Global Operations Program at MITCataloged from student-submitted PDF version of thesis. "June 2019."Includes bibliographical references (pages 87-89).
DepartmentMassachusetts Institute of Technology. Department of Chemical Engineering; Sloan School of Management; Leaders for Global Operations Program
Massachusetts Institute of Technology
Chemical Engineering., Sloan School of Management., Leaders for Global Operations Program.