(273b) Pharmacy on Demand: A Case of Arrested Development or Flourishing Adolescence

Pharmacy on Demand is an initiative to realize mobile production skids that utilize continuous manufacturing unit operations to produce both active pharmaceutical ingredients and final drug products. This is in direct response to rising drug prices and centralized supply chains. These proof-of-concept units placed an emphasis on automation, reduced form factor, and modularity. Throughout the lifetime of the PoD initiative, substantial advances have been made in complex reaction telescoping, real time formulation, reaction engineering, and pumping technologies. Our vision of an end state for the Pharmacy on Demand project, however, has taken on a longer view. We have begun to re-imagine how we both develop syntheses and prototype equipment with respect to regulatory guidelines, and in particular, how we address life-cycle management. We have begun to apply these updated workflows to the new additions to our product portfolio in conjunction with best practices from other industries on supply chain management. We believe PoD is growing up. We believe we have emerged from a proof-of-concept mindset to a flourishing adolescence as we prepare for a suite of commercial regulatory filings in 2022 and beyond. We wish to share the new processes we have developed for these molecules as well as generalized workflows to decrease the transition time from batch discovery to continuous production mode.

References:

1. Mascia, P. L. Heider, H. Zhang, R. Lakerveld, B. Benyahia, P. I. Barton, R. D. Braatz, C. L. Cooney, J. M. B. Evans, T. F. Jamison, K. F. Jensen, A. S. Myerson and B. L. Trout, Angew. Chem., Int. Ed., 52, 12359–12363
2. P. Cole, J. M. Groh, M. D. Johnson, C. L. Burcham, B. M. Campbell, W. D. Diseroad, M. R. Heller, J. R. Howell, N. J. Kallman, T. M. Koenig, S. A. May, R. D. Miller, D. Mitchell, D. P. Myers, S. S. Myers, J. L. Phillips, C. S. Polster, T. D. White, J. Cashman, D. Hurley, R. Moylan, P. Sheehan, R. D. Spencer, K. Desmond, P. Desmond and O. Gowran, Science, 2017, 356, 1144–1150
3. Adamo, R. L. Beingessner, M. Behnam, J. Chen, T. F. Jamison, K. F. Jensen, J.-C. M. Monbaliu, A. S. Myerson, E. M. Revalor, D. R. Snead, T. Stelzer, N. Weeranoppanant, S. Y. Wong and P. Zhang, Science, 2016, 352, 61–67
4. Rogers, L., Briggs, N., Achermann, R., Adamo, A., Azad, M., Brancazio, D. et al., Continuous Production of Five Active Pharmaceutical Ingredients in Flexible Plug-and-Play Modules: A Demonstration Campaign. Organic Process Research & Development 2020, 24 (10), 2183-2196.
5. Imbrogno, J., Rogers, L., Thomas, D., Jensen, K.F. Continuous Purification of Active Pharmaceutical Ingredients Utilizing Polymer Membrane Surface Wettability. Commun., 2018, 54, 70-73.
6. Srai JS, Graham G, Hennelly P, Phillips W, Kapletia D, Lorentz H. Distributed Manufacturing: A new form of localised production?, International Journal of Operations and Production Management. 2020 40 (6), 697-727
7. Harrington, T.S., Phillips, M.A., Srai, J.S. 2016, Reconfiguring global pharmaceutical value networks through targeted technology interventions, International Journal of Production Research, http://dx.doi.org/10.1080/00207543.2016.1221541
8. https://www.fda.gov/regulatory-information/search-fda-guidance-documents...