-
Continuous Manufacturing to Improve Pharmaceutical Quality: Research Examples and Opportunities
| Contributor(s):: Geng Tian
Continuous manufacturing (CM) of drug substances and drug productsProcess modeling and simulation (M&S) for CM at FDACM research highlightsOpportunities of CM for generic drug productsPharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing -...
-
Model-based comparison of batch and flow syntheses of an active pharmaceutical ingredient using heterogeneous hydrogenation
| Contributor(s):: Kim, J, Yonekura, HWatanabe, T, Yoshikawa, S, Nakanishi, H, Badr, S, Sugiyama, H
This work presents a model-based comparison of the batch and flow syntheses for doripenem, which is an antibiotic active pharmaceutical ingredient. The targeted reaction is heterogeneous hydrogenation, the most widely used method for reduction reaction in drug syntheses. We developed rigorous...
-
Flow Chemistry, Continuous Processing, and Continuous Manufacturing: A Pharmaceutical Perspective
| Contributor(s):: May, SA
Flow chemistry has become a vibrant area for Research Article over the past decade. This perspective is intended to capture insights on how these advances have and will continue to impact the development and commercialization of active pharmaceutical ingredients. A series of chemistry examples...
-
Continuous manufacturing of drug substance and small molecules: process and equipment view
| Contributor(s):: Yazdanpanah, Nima
The continuous manufacturing of pharmaceutical compounds and fine chemicals is in high interest for the industry due to significant technical, quality, and economical advantages. This manufacturing method has its own challenges. Beside the more efficient, safer, and greener synthesis rout, a new...
-
Continuous flow technology vs. the batch-by-batch approach to produce pharmaceutical compounds
| Contributor(s):: Cole, KP, Johnson, MD
Introduction: For the manufacture of small molecule drugs, many pharmaceutical innovator companies have recently invested in continuous processing, which can offer significant technical and economic advantages over traditional batch methodology. This Expert Review will describe the reasons for...
-
Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing
| Contributor(s):: Burcham, Christopher L., Florence, Alastair J., Johnson, Martin D.
The pharmaceutical industry has found new applications for the use of continuous processing for the manufacture of new therapies currently in development. The transformation has been encouraged by regulatory bodies as well as driven by cost reduction, decreased development cycles, access to new...
-
Achieving Continuous Manufacturing: Technologies and Approaches for Synthesis, Workup, and Isolation of Drug Substance May 20-21, 2014 Continuous Manufacturing Symposium
| Contributor(s):: Baxendale, IR, Braatz, RDHodnett, BK, Jensen, KF, Johnson, MD, Sharratt, P, Sherlock, JP, Florence, AJ
This whitepaper highlights current challenges and opportunities associated with continuous synthesis, workup, and crystallization of active pharmaceutical ingredients (drug substances). We describe the technologies and requirements at each stage and emphasize the different considerations for...
-
Achieving Continuous Manufacturing for Final Dosage Formation: Challenges and How to Meet Them
| Contributor(s):: Byrn, Stephen, Futran, Maricio, Thomas, Hayden, Jayjock, Eric, Maron, Nicola, Meyer, Robert F., Myerson, Allan S., Thien, Michael P., Trout, Bernhardt L.
We describe the key issues and possibilities for continuous final dosage formation, otherwise known as downstream processing or drug product manufacturing. A distinction is made between heterogeneous processing and homogeneous processing, the latter of which is expected to add more value to...