Open Access
Economic Analysis of Integrated Continuous and Batch Pharmaceutical Manufacturing
Spencer D. Schaber,Dimitrios I. Gerogiorgis,Rohit Ramachandran,James M. B. Evans,Paul I. Barton,Bernhardt L. Trout +5 more
TLDR
In this paper, the authors compared the costs of a dedicated continuous manufacturing process to synthesize an active pharmaceutical ingredient (API) and formulate it into tablets for a production scale of 2000 t of tablets per year, with raw material cost, production yield and API loading varied over broad ranges.Abstract:
The capital, operating, and overall costs of a dedicated continuous manufacturing process to synthesize an active pharmaceutical ingredient (API) and formulate it into tablets are estimated for a production scale of 2000 t of tablets per year, with raw material cost, production yield, and API loading varied over broad ranges. Costs are compared to batch production in a dedicated facility. Synthesis begins with a key organic intermediate three synthetic steps before the final API; results are given for key intermediate (KI) costs of $100 to $3000/kg, with drug loadings in the tablet of 10 and 50 wt %. The novel continuous process described here is being developed by an interdisciplinary team of 20 researchers. Since yields are not yet well-known, and continuous processes typically have better yields than batch ones, the overall yields of the continuous processes with recycling were set equal to that of the batch process. Without recycling, yields are 10% lower, but less equipment is required. The continuous process has not been built at large scale, so Wroth factors and other assumptions were used to estimate costs. Capital expenditures for continuous production were estimated to be 20 to 76% lower, depending on the drug loading, KI cost, and process chosen; operating expenditures were estimated to be between 40% lower and 9% higher. The novel continuous process with recycling coupled to a novel direct tablet formation process yields the best overall cost savings in each drug loading/KI price scenario: estimated savings range from 9 to 40%. Overall cost savings are also given assuming the yield in the continuous case is 10% above and 10% below that of the batch process. Even when yields in the continuous case are lower than in the batch case, savings can still be achieved because the labor, materials handling, CapEx, and other savings compensate.read more
Citations
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Journal ArticleDOI
On-demand continuous-flow production of pharmaceuticals in a compact, reconfigurable system
Andrea Adamo,Rachel L. Beingessner,Mohsen Behnam,Jie Chen,Timothy F. Jamison,Klavs F. Jensen,Jean-Christophe Monbaliu,Allan S. Myerson,Eve Revalor,David R. Snead,Torsten Stelzer,Nopphon Weeranoppanant,Shin Yee Wong,Ping Zhang +13 more
TL;DR: An apparatus roughly the size of a household refrigerator is presented that can synthesize and purify pharmaceuticals under continuous-flow conditions, and the synthesis and formulation of active pharmaceutical ingredients in a compact, reconfigurable manufacturing platform is reported.
Journal ArticleDOI
Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production
Sau L. Lee,Thomas F. O’Connor,Xiaochuan Yang,Celia N. Cruz,Sharmista Chatterjee,Rapti D. Madurawe,Christine M. V. Moore,Lawrence X. Yu,Janet Woodcock +8 more
TL;DR: The Food and Drug Administration (FDA) regulates pharmaceutical drug products to ensure a continuous supply of high-quality drugs in the USA as mentioned in this paper, where the FDA supports the implementation of continuous manufacturing using science-and risk-based approaches.
Journal ArticleDOI
End‐to‐End Continuous Manufacturing of Pharmaceuticals: Integrated Synthesis, Purification, and Final Dosage Formation
Salvatore Mascia,Patrick L. Heider,Haitao Zhang,Richard Lakerveld,Brahim Benyahia,Paul I. Barton,Richard D. Braatz,Charles L. Cooney,James M. B. Evans,Timothy F. Jamison,Klavs F. Jensen,Allan S. Myerson,Bernhardt L. Trout +12 more
TL;DR: The continuous pilot-scale plant used a novel route that incorporated many advantages of continuous-flow processes to produce active pharmaceutical ingredients and the drug product in one integrated system.
Book ChapterDOI
Multifunctional nanocrystals for cancer therapy: a potential nanocarrier
Emil Joseph,Gautam Singhvi +1 more
TL;DR: This review gives an overview of recent advances and current status of nanocrystals, especially with respect to the method of preparations, physicochemical characterizations, in vitro/in vivo performance, scale-up techniques and applications in the field of drug delivery for different tumor targeting.
Journal ArticleDOI
Continuous flow biocatalysis.
TL;DR: This Review explores continuous flow biocatalysts with emphasis on new technology, enzymes, whole cells, co-factor recycling, and immobilization methods for the synthesis of pharmaceuticals, value-added chemicals, and materials.
References
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Perrys chemical engineers handbook
TL;DR: Perry's Chemical Engineers' Handbook as mentioned in this paper is a free download pdf for chemical engineering applications, from the fundamentals to details on computer applications and control, and it can be found in any computer science course.
Book
Chemical Process Equipment : Selection and Design
TL;DR: In this article, the authors present a guide to the selection and design of a wide range of chemical process equipment, with a focus on specific information concerning the process design and performance of equipment.
Journal ArticleDOI
Microreactor Technology: A Revolution for the Fine Chemical and Pharmaceutical Industries?
TL;DR: In this paper, the authors proposed that 50% of reactions in the fine chemical/pharmaceutical industry could benefit from a continuous process based mainly on microreactor technology, however, the frequent presence of a solid phase still hinders the widespread application of such a technology as a multi-purpose solution.
Journal ArticleDOI
Continuous Processing in the Pharmaceutical Industry: Changing the Mind Set
TL;DR: In this paper, the authors examine how chemical engineers can use the opportunity that arises from this changed regulatory environment to revisit their own ideas and drive a change of mind set within the industry.
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