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Allan Clarke
Lead a project called Liquid Dispensing Technologies (LDT) in mid-2000's leading to a commercial-scale High-Potency-API continuous oral tablet manufacturing process. See chapter about...
https://cmkc.usp.org/members/1675
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Daniel Treffer
https://cmkc.usp.org/members/1489
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USP's first TG - Control Strategies for Solid Oral Drug Product
Forum › defaultsection › technical-guides
USP is excited to share our first technical guide (TG) on PCM, focusing on solid oral drug product manufacturing control strategies.
As we all know, the concept of control strategy is well...
https://cmkc.usp.org/forum/defaultsection/technical-guides/69
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Xiao-Dong Wu
https://cmkc.usp.org/members/1169
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How do you maintain lot integrity in a continuous manufacturing process?
Forum › defaultsection › general
As continuous manufacturing (CM) becomes more prevalent, the question of lot integrity will become more important. The company where I work presently has been dealing with this question for...
https://cmkc.usp.org/forum/defaultsection/general/24
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Using Residence Time Distributions (RTDs) to Address the Traceability of Raw Materials in Continuous Pharmaceutical Manufacturing
Contributor(s):: Engisch, William, Muzzio, Fernando
Continuous processing in pharmaceutical manufacturing is a relatively new approach that has generated significant attention. While it has been used for decades in other industries, showing significant advantages, the pharmaceutical industry has been slow in its adoption of continuous processing,...
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The synthesis of active pharmaceutical ingredients (APIs) using continuous flow chemistry
Contributor(s):: Baumann, M, Baxendale, IR
The implementation of continuous flow processing as a key enabling technology has transformed the way we conduct chemistry and has expanded our synthetic capabilities. As a result many new preparative routes have been designed towards commercially relevant drug compounds achieving more efficient...
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The Use of PAT and Off-line Methods for Monitoring of Roller Compacted Ribbon and Granule Properties with a View to Continuous Processing
Contributor(s):: McAuliffe M.A.P., Omahony G.E., Blackshields C.A., Collins J.A., Egan D.P., Kiernan L., Oneill E., Lenihan S., Walker G.M., Crean A.M.
Real-time process monitoring using process analytical technology (PAT) tools can augment process understanding, enable improved process control, and hence facilitate the production of high-quality pharmaceutical products. While beneficial for batch processes, the availability of PAT tools to...
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Small-Volume Continuous Manufacturing of Merestinib. Part 1. Process Development and Demonstration
Contributor(s):: Cole, KP, Reizman, BJHess, M, Groh, JM, Laurila, ME, Cope, RF, Campbell, BM, Forst, MB, Burt, JL, Maloney, TD, Johnson, MD, Mitchell, D, Polster, CS, Mitra, AW, Boukerche, M, Conder, EW, Braden, TM, Miller, RD, Heller, MR, Phillips, JL, Howell, JR
Development of a small volume continuous process that used a combination of batch and flow unit operations to manufacture the small molecule oncolytic candidate merestinib is described. Continuous processing was enabled following the identification and development of suitable chemical...
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Small-Volume Continuous Manufacturing of Merestinib. Part 2.Technology Transfer and cGMP Manufacturing
Contributor(s):: Reizman, Brandon J., Hess, Molly, Burt, Justin L., Maloney, Todd D., Johnson, Martin D., Laurila, Michael E., Cope, Richard F., Luciani, Carla V., Buser, Jonas Y., Campbell, Bradley M., Forst, Mindy B., Mitchell, David, Braden, Timothy M., Lippelt, Christopher K., Boukerche, Moussa, Starkey, Derek R., Miller, Richard D., Chen, Jing, Sun, Baoquan, Kwok, Martin, Zhang, Xin, Tadayon, Sam, Huang, Ping
Technology transfer of a small volume continuous (SVC) process and Current Good Manufacturing Practices (cGMP) manufacturing of merestinib are described. A hybrid batch-SVC campaign was completed at a contract manufacturing organization under cGMP. The decision process by which unit operations...
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Simulation-Based Design of an Efficient Control System for the Continuous Purification and Processing of Active Pharmaceutical Ingredients
Contributor(s):: Sen, M, Singh, R, Ramachandran, R
In this study, an efficient system-wide controlsystem has been designed for the integrated continuous purification and processing of the active pharmaceutical ingredient (API). The control strategy is based on the regulatory PID controller which is most widely used in the manufacturing industry...
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Real-Time Monitoring of Powder Mass Flowrates for Plant-Wide Control of a Continuous Direct Compaction Tablet Manufacturing Process
Contributor(s):: Huang, Yan-Shu, Medina-González, Sergio Straiton, Benjamin Keller, Joshua, Marashdeh, Qussai, Gonzalez, Marcial, Nagy, Zoltan, Reklaitis, Gintaras V.
While measurement and monitoring of powder/particulate mass flow rate are not essential to the execution of traditional batch pharmaceutical tablet manufacturing, in continuous operation, it is an important additional critical process parameter. It has a key role both in establishing that the...
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Process optimization for continuous extrusion wet granulation
Contributor(s):: Tan, L, Carella, AJ, Ren, YK, Lo, JB
Three granulating binders in high drug-load acetaminophen blends were evaluated using high shear granulation and extrusion granulation. A polymethacrylate binder enhanced tablet tensile strength with rapid disintegration in simulated gastric fluid, whereas polyvinylpyrrolidone and hydroxypropyl...
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Process dynamics and control of API manufacturing and purification processes
Contributor(s):: Sen, Maitraye, Singh, Ravendra, Ramachandran, Rohit
The pharmaceutical industries have started transitioning toward continuous mode of manufacturing recently. Due to many advantages of the continuous manufacturing over the traditional alternatives, the industries are putting huge effort to efficiently adapt the continuous processing mode. However,...
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Process design applied to optimise a directly compressible powder produced via a continuous manufacturing process
Contributor(s):: Gonnissen, Y., Goncalves, S. I. V., De Geest, B. G., Remon, J. P., Vervaet, C.
Manufacturing of 'ready-to-compress' powder mixtures for direct compression was performed by spray drying, without granulation, milling and/or blending steps in between spray drying and compaction. Powder mixtures containing acetaminophen, mannitol, erythritol, maltodextrin, crospovidone,...
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Pharmaceutical Crystallization
Contributor(s):: Chen, J, Sarma, BEvans, JMB, Myerson, AS
Crystallization is crucial in the pharmaceutical industry as a separation process for intermediates and as the final step in the manufacture of active pharmaceutical ingredients (APIs). In this perspective article to celebrate 10 years of Crystal Growth & Design, we focus on three areas related...
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Multi-scale flowsheet simulation of an integrated continuous purification-downstream pharmaceutical manufacturing process
Contributor(s):: Sen, M, Chaudhury, ASingh, R, John, J, Ramachandran, R
Properties of active pharmaceutical ingredients influence the critical quality attributes (CQAs) of final solid dosage forms (e. g. tablets). In the last decade, continuous manufacturing has been shown to be a promising alternative to batch processing in the pharmaceutical industry. Therefore, a...
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Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production
Contributor(s):: Lee, SL, O'Connor, TFYang, XC, Cruz, CN, Chatterjee, S, Madurawe, RD, Moore, CMV, Yu, LX, Woodcock, J
Currently, there is a high level of interest in the pharmaceutical industry in continuous-manufacturing strategies, integrated with online-monitoring tools, that are designed, optimized, and controlled using advanced, model-predictive systems. These strategies can accelerate the full...
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Model-Based Control-Loop Performance of a Continuous Direct Compaction Process
Contributor(s):: Ramachandran, Rohit, Arjunan, Jeyrathan, Chaudhury, Anwesha, Ierapetritou, Marianthi G
This study is concerned with enhanced model-based control of a continuous direct compression pharmaceutical process. The control-loop performance is assessed in silico and results obtained will be incorporated into the pilot plant facility of the continuous direct compaction process at the NSF...
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Loss-in-Weight Feeding Trials Case Study: Pharmaceutical Formulation
Contributor(s):: Engisch, WE, Muzzio, FJ
This article presents a case study of a continuous feeding strategy for five pharmaceutical components (active pharmaceutical ingredient (API), Prosolv HD90, crospovidone, magnesium stearate, and colloidal silicon dioxide), for the purpose of developing a direct compression continuous...
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Impact of screw configuration on the particle size distribution of granules produced by twin screw granulation
Contributor(s):: Vercruysse, J, Burggraeve, A., Fonteyne, M., Cappuyns, P., Delaet, U., Van Assche, I., De Beer, T., Remon, J. P., Vervaet, C.
Twin screw granulation (TSG) has been reported by different Research Article groups as an attractive technology for continuous wet granulation. However, in contrast to fluidized bed granulation, granules produced via this technique typically have a wide and multimodal particle size distribution...
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Implementation of an advanced hybrid MPC–PID control system using PAT tools into a direct compaction continuous pharmaceutical tablet manufacturing pilot plan
Contributor(s):: Singh, Ravendra, Sahay, Abhishek, Karry, Krizia, Muzzio, Fernando, Ierapetritou, Marianthi, Ramachandran, Rohit
It is desirable for a pharmaceutical final dosage form to be manufactured through a quality by design (QbD)-based approach rather than a quality by testing (QbT) approach. An automatic feedback control system coupled with PAT tools that is part of the QbD paradigm shift, has the potential to...
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Implementation of control system into continuous pharmaceutical manufacturing pilot plant (powder to tablet)
Contributor(s):: Singh, Ravendra
Real-time process control is highly desired for efficient quality by design (QbD)-based pharmaceutical manufacturing. A control system ensures the predefined end-product quality, satisfies the high regulatory constraints, facilitates real-time release of the product, and optimizes the resources....
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Hybrid advanced control of flexible multipurpose continuous tablet manufacturing process via direct compaction
Contributor(s):: Singh, Ravendra, Ierapetritou, Marianthi, Ramachandran, Rohit
With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing.
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Forbidden Chemistries - Paths to a Sustainable Future Engaging Continuous Processing
Contributor(s):: Gutmann, B, Kappe, CO
Optimizing current chemical processes alone does not yield the improvements required in the fine chemical and pharmaceutical industries. At least partially, a switch from batch to continuous manufacturing is needed. Cost-, time-, and atom-efficient routes frequently demand the application of high...