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Journal articles on the topic 'Continuous pharmaceutical manufacturing'

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Author: Grafiati
Published: 14 March 2023

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1

Korhonen, Ossi. "Continuous Pharmaceutical Manufacturing." Pharmaceutics 12, no. 10 (September 23, 2020): 910. http://dx.doi.org/10.3390/pharmaceutics12100910.

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2

Burcham, Christopher L., Alastair J. Florence, and Martin D. Johnson. "Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing." Annual Review of Chemical and Biomolecular Engineering 9, no. 1 (June 7, 2018): 253–81. http://dx.doi.org/10.1146/annurev-chembioeng-060817-084355.

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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 chemistries not practical in batch, improved safety, flexible manufacturing platforms, and improved product quality assurance. The transformation from batch to continuous manufacturing processing is the focus of this review. The review is limited to small, chemically synthesized organic molecules and encompasses the manufacture of both active pharmaceutical ingredients (APIs) and the subsequent drug product. Continuous drug product is currently used in approved processes. A few examples of production of APIs under current good manufacturing practice conditions using continuous processing steps have been published in the past five years, but they are lagging behind continuous drug product with respect to regulatory filings.
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3

Hock, Sia Chong, Teh Kee Siang, and Chan Lai Wah. "Continuous manufacturing versus batch manufacturing: benefits, opportunities and challenges for manufacturers and regulators." Generics and Biosimilars Initiative Journal 10, no. 1 (March 15, 2021): 44–56. http://dx.doi.org/10.5639/gabij.2021.1001.004.

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Continuous manufacturing (CM) is the integration of a series of unit operations, processing materials continually to produce the final pharmaceutical product. In recent years, CM of pharmaceuticals has transformed from buzzword to reality, with at least eight currently approved drugs produced by CM. Propelled by various driving forces, manufacturers and regulators have recognized the benefits of CM and are awaiting the completion of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q13, a harmonized guideline on CM that would be implemented by ICH members. Although significant progress is evident, the uptake of CM is still sluggish in the pharmaceutical industry due to many existing challenges that have hindered manufacturers from adopting this technology. The top two barriers that manufacturers currently face are regulatory uncertainties and high initial cost. These issues are crucial in unleashing the untapped potential of CM, which has significant implications on patients’ access to life-saving medicines, while mutually benefitting manufacturers and regulators. Despite numerous studies, there have been few existing publications that review current regulatory guidelines, highlight the latest challenges extensively and propose recommendations that are applicable for all pharmaceuticals and biopharmaceuticals. Therefore, this critical review aims to present the recent progress and existing challenges to provide greater clarity for manufacturers on CM. This review also proposes vital recommendations and future perspectives. These include regulatory harmonization, managing financial risks, hybrid processes, capacity building, a culture of quality and Pharma 4.0. While regulators and the industry work towards creating a harmonized guideline on CM, manufacturers should focus on overcoming existing cost, technical and cultural challenges to facilitate the implementation of CM.
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4

TAHARA, Kohei. "Spherical Crystallization for Pharmaceutical Continuous Manufacturing System." Hosokawa Powder Technology Foundation ANNUAL REPORT 25 (2017): 75–78. http://dx.doi.org/10.14356/hptf.15111.

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5

May, Scott A. "Flow chemistry, continuous processing, and continuous manufacturing: A pharmaceutical perspective." Journal of Flow Chemistry 7, no. 3–4 (September 2017): 137–45. http://dx.doi.org/10.1556/1846.2017.00029.

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6

Desai, Parind Mahendrakumar, Griet Van Vaerenbergh, Jim Holman, Celine Valeria Liew, and Paul Wan Sia Heng. "Continuous manufacturing: the future in pharmaceutical solid dosage form manufacturing." Pharmaceutical Bioprocessing 3, no. 5 (September 2015): 357–60. http://dx.doi.org/10.4155/pbp.15.19.

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7

Myerson, Allan S., Markus Krumme, Moheb Nasr, Hayden Thomas, and Richard D. Braatz. "Control Systems Engineering in Continuous Pharmaceutical Manufacturing May 20–21, 2014 Continuous Manufacturing Symposium." Journal of Pharmaceutical Sciences 104, no. 3 (March 2015): 832–39. http://dx.doi.org/10.1002/jps.24311.

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8

Wahlich, John. "Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms." Pharmaceutics 13, no. 8 (August 22, 2021): 1311. http://dx.doi.org/10.3390/pharmaceutics13081311.

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Continuous manufacturing (CM) is defined as a process in which the input material(s) are continuously fed into and transformed, and the processed output materials are continuously removed from the system. CM can be considered as matching the FDA’s so-called ‘Desired State’ of pharmaceutical manufacturing in the twenty-first century as discussed in their 2004 publication on ‘Innovation and Continuous Improvement in Pharmaceutical Manufacturing’. Yet, focused attention on CM did not really start until 2014, and the first product manufactured by CM was only approved in 2015. This review describes some of the benefits and challenges of introducing a CM process with a particular focus on small molecule solid oral dosage forms. The review is a useful introduction for individuals wishing to learn more about CM.
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9

Lee, Sau L., Thomas F. O’Connor, Xiaochuan Yang, Celia N. Cruz, Sharmista Chatterjee, Rapti D. Madurawe, Christine M. V. Moore, Lawrence X. Yu, and Janet Woodcock. "Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production." Journal of Pharmaceutical Innovation 10, no. 3 (March 19, 2015): 191–99. http://dx.doi.org/10.1007/s12247-015-9215-8.

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10

Rehrl, Jakob, Julia Kruisz, Stephan Sacher, Johannes Khinast, and Martin Horn. "Optimized continuous pharmaceutical manufacturing via model-predictive control." International Journal of Pharmaceutics 510, no. 1 (August 2016): 100–115. http://dx.doi.org/10.1016/j.ijpharm.2016.06.024.

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11

Horáková, Pavlína, and Kamila Kočí. "Continuous-Flow Chemistry and Photochemistry for Manufacturing of Active Pharmaceutical Ingredients." Molecules 27, no. 23 (December 4, 2022): 8536. http://dx.doi.org/10.3390/molecules27238536.

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An active pharmaceutical ingredient (API) is any substance in a pharmaceutical product that is biologically active. That means the specific molecular entity is capable of achieving a defined biological effect on the target. These ingredients need to meet very strict limits; chemical and optical purity are considered to be the most important ones. A continuous-flow synthetic methodology which utilizes a continuously flowing stream of reactive fluids can be easily combined with photochemistry, which works with the chemical effects of light. These methods can be useful tools to meet these strict limits. Both of these methods are unique and powerful tools for the preparation of natural products or active pharmaceutical ingredients and their precursors with high structural complexity under mild conditions. This review shows some main directions in the field of active pharmaceutical ingredients’ preparation using continuous-flow chemistry and photochemistry with numerous examples of industry and laboratory-scale applications.
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12

Bostijn, N., J. Van Renterghem, W. Dhondt, C. Vervaet, and T. De Beer. "A continuous manufacturing concept for a pharmaceutical oral suspension." European Journal of Pharmaceutical Sciences 123 (October 2018): 576–83. http://dx.doi.org/10.1016/j.ejps.2018.08.015.

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13

Sugiyama, Hirokazu, and Rainer Schmidt. "Business Process Model of Continuous Improvement in Pharmaceutical Manufacturing." KAGAKU KOGAKU RONBUNSHU 40, no. 3 (2014): 201–10. http://dx.doi.org/10.1252/kakoronbunshu.40.201.

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14

Diab, Samir, and Dimitrios I. Gerogiorgis. "Design Space Identification and Visualization for Continuous Pharmaceutical Manufacturing." Pharmaceutics 12, no. 3 (March 5, 2020): 235. http://dx.doi.org/10.3390/pharmaceutics12030235.

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Progress in continuous flow chemistry over the past two decades has facilitated significant developments in the flow synthesis of a wide variety of Active Pharmaceutical Ingredients (APIs), the foundation of Continuous Pharmaceutical Manufacturing (CPM), which has gained interest for its potential to reduce material usage, energy and costs and the ability to access novel processing windows that would be otherwise hazardous if operated via traditional batch techniques. Design space investigation of manufacturing processes is a useful task in elucidating attainable regions of process performance and product quality attributes that can allow insight into process design and optimization prior to costly experimental campaigns and pilot plant studies. This study discusses recent demonstrations from the literature on design space investigation and visualization for continuous API production and highlights attainable regions of recoveries, material efficiencies, flowsheet complexity and cost components for upstream (reaction + separation) via modeling, simulation and nonlinear optimization, providing insight into optimal CPM operation.
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15

Zhang, Ping, Nopphon Weeranoppanant, Dale A. Thomas, Kohei Tahara, Torsten Stelzer, Mary Grace Russell, Marcus O'Mahony, et al. "Advanced Continuous Flow Platform for On-Demand Pharmaceutical Manufacturing." Chemistry - A European Journal 24, no. 11 (January 31, 2018): 2776–84. http://dx.doi.org/10.1002/chem.201706004.

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16

Yadav, Vikramaditya G., and Gregory Stephanopoulos. "Metabolic Engineering: The Ultimate Paradigm for Continuous Pharmaceutical Manufacturing." ChemSusChem 7, no. 7 (April 9, 2014): 1847–53. http://dx.doi.org/10.1002/cssc.201301219.

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17

Helal, Nada A., Ola Elnoweam, Heba Abdullah Eassa, Ahmed M. Amer, Mohamed Ashraf Eltokhy, Mohamed A. Helal, Heba A. Fayyaz, and Mohamed Ismail Nounou. "Integrated continuous manufacturing in pharmaceutical industry: current evolutionary steps toward revolutionary future." Pharmaceutical Patent Analyst 8, no. 4 (July 2019): 139–61. http://dx.doi.org/10.4155/ppa-2019-0011.

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Continuous manufacturing (CM) has the potential to provide pharmaceutical products with better quality, improved yield and with reduced cost and time. Moreover, ease of scale-up, small manufacturing footprint and on-line/in-line monitoring and control of the process are other merits for CM. Regulating authorities are supporting the adoption of CM by pharmaceutical manufacturers through issuing proper guidelines. However, implementation of this technology in pharmaceutical industry is encountered by a number of challenges regarding the process development and quality assurance. This article provides a background on the implementation of CM in pharmaceutical industry, literature survey of the most recent state-of-the-art technologies and critically discussing the encountered challenges and its future prospective in pharmaceutical industry.
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18

Ouranidis, Andreas, Christina Davidopoulou, Reald-Konstantinos Tashi, and Kyriakos Kachrimanis. "Pharma 4.0 Continuous mRNA Drug Products Manufacturing." Pharmaceutics 13, no. 9 (August 31, 2021): 1371. http://dx.doi.org/10.3390/pharmaceutics13091371.

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Continuous mRNA drugs manufacturing is perceived to nurture flow processes featuring quality by design, controlled automation, real time validation, robustness, and reproducibility, pertaining to regulatory harmonization. However, the actual adaptation of the latter remains elusive, hence batch-to-continuous transition would a priori necessitate holistic process understanding. In addition, the cost related to experimental, pilot manufacturing lines development and operations thereof renders such venture prohibitive. Systems-based Pharmaceutics 4.0 digital design enabling tools, i.e., converging mass and energy balance simulations, Monte-Carlo machine learning iterations, and spatial arrangement analysis were recruited herein to overcome the aforementioned barriers. The primary objective of this work is to hierarchically design the related bioprocesses, embedded in scalable devices, compatible with continuous operation. Our secondary objective is to harvest the obtained technological data and conduct resource commitment analysis. We herein demonstrate for first time the feasibility of the continuous, end-to-end production of sterile mRNA formulated into lipid nanocarriers, defining the equipment specifications and the desired operational space. Moreover, we find that the cell lysis modules and the linearization enzymes ascend as the principal resource-intensive model factors, accounting for 40% and 42% of the equipment and raw material, respectively. We calculate MSPD 1.30–1.45 €, demonstrating low margin lifecycle fluctuation.
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19

Garcia, Fernando A., and Michael W. Vandiver. "Throughput Optimization of Continuous Biopharmaceutical Manufacturing Facilities." PDA Journal of Pharmaceutical Science and Technology 71, no. 3 (December 14, 2016): 189–205. http://dx.doi.org/10.5731/pdajpst.2016.006882.

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20

Piñeiro, David Pérez, Anastasia Nikolakopoulou, Johannes Jäschke, and Richard D. Braatz. "Self-Optimizing Control of a Continuous-Flow Pharmaceutical Manufacturing Plant." IFAC-PapersOnLine 53, no. 2 (2020): 11601–6. http://dx.doi.org/10.1016/j.ifacol.2020.12.640.

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21

Yang, Wenhui, Wuxi Qian, Zhihong Yuan, and Bingzhen Chen. "Perspectives on the flexibility analysis for continuous pharmaceutical manufacturing processes." Chinese Journal of Chemical Engineering 41 (January 2022): 29–41. http://dx.doi.org/10.1016/j.cjche.2021.12.005.

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22

Dilley, Garrett. "Guest Editorial: Continuous Manufacturing at Johnson Matthey For Pharmaceutical Applications." Johnson Matthey Technology Review 63, no. 3 (July 1, 2019): 148–49. http://dx.doi.org/10.1595/205651319x15579077595864.

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23

Roggo, Yves, Morgane Jelsch, Philipp Heger, Simon Ensslin, and Markus Krumme. "Deep learning for continuous manufacturing of pharmaceutical solid dosage form." European Journal of Pharmaceutics and Biopharmaceutics 153 (August 2020): 95–105. http://dx.doi.org/10.1016/j.ejpb.2020.06.002.

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24

Jolliffe, Hikaru G., and Dimitrios I. Gerogiorgis. "Process modelling and simulation for continuous pharmaceutical manufacturing of ibuprofen." Chemical Engineering Research and Design 97 (May 2015): 175–91. http://dx.doi.org/10.1016/j.cherd.2014.12.005.

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25

Jolliffe, Hikaru G., and Dimitrios I. Gerogiorgis. "Process modelling and simulation for continuous pharmaceutical manufacturing of artemisinin." Chemical Engineering Research and Design 112 (August 2016): 310–25. http://dx.doi.org/10.1016/j.cherd.2016.02.017.

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26

Ierapetritou, Marianthi, Fernando Muzzio, and Gintaras Reklaitis. "Perspectives on the continuous manufacturing of powder-based pharmaceutical processes." AIChE Journal 62, no. 6 (March 18, 2016): 1846–62. http://dx.doi.org/10.1002/aic.15210.

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27

Lee, Boung Wook, Kehua Yin, Kevin Splaine, and Brian Roesch. "Thin-Film Evaporator Model for Continuous Active Pharmaceutical Ingredient Manufacturing." Industrial & Engineering Chemistry Research 59, no. 7 (January 17, 2020): 3252–60. http://dx.doi.org/10.1021/acs.iecr.9b03974.

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28

Wong, Wee, Ewan Chee, Jiali Li, and Xiaonan Wang. "Recurrent Neural Network-Based Model Predictive Control for Continuous Pharmaceutical Manufacturing." Mathematics 6, no. 11 (November 7, 2018): 242. http://dx.doi.org/10.3390/math6110242.

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The pharmaceutical industry has witnessed exponential growth in transforming operations towards continuous manufacturing to increase profitability, reduce waste and extend product ranges. Model predictive control (MPC) can be applied to enable this vision by providing superior regulation of critical quality attributes (CQAs). For MPC, obtaining a workable system model is of fundamental importance, especially if complex process dynamics and reaction kinetics are present. Whilst physics-based models are desirable, obtaining models that are effective and fit-for-purpose may not always be practical, and industries have often relied on data-driven approaches for system identification instead. In this work, we demonstrate the applicability of recurrent neural networks (RNNs) in MPC applications in continuous pharmaceutical manufacturing. RNNs were shown to be especially well-suited for modelling dynamical systems due to their mathematical structure, and their use in system identification has enabled satisfactory closed-loop performance for MPC of a complex reaction in a single continuous-stirred tank reactor (CSTR) for pharmaceutical manufacturing.
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29

McWilliams, J. Christopher, Ayman D. Allian, Suzanne M. Opalka, Scott A. May, Michel Journet, and Timothy M. Braden. "The Evolving State of Continuous Processing in Pharmaceutical API Manufacturing: A Survey of Pharmaceutical Companies and Contract Manufacturing Organizations." Organic Process Research & Development 22, no. 9 (August 8, 2018): 1143–66. http://dx.doi.org/10.1021/acs.oprd.8b00160.

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30

Takizawa, Bayan Teisho, Stephen Christopher Born, and Salvatore Mascia. "Leveraging Integrated Continuous Manufacturing to Address Critical Issues in the U.S. Military." Military Medicine 185, Supplement_1 (January 2020): 656–62. http://dx.doi.org/10.1093/milmed/usz245.

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ABSTRACT There is a tremendous opportunity to modernize the pharmaceutical manufacturing industry—relinquishing outdated machines that have been used for decades, and replacing them with state-of-the-art equipment that reflect more contemporary advanced technologies. This article describes how the implementation of continuous manufacturing, replacing outdated batch systems, can positively impact our health care sector. Important benefits will include the creation of advanced pharmaceutical manufacturing jobs in the United States, the establishment of capabilities and capacity to quickly produce drugs critical to U.S. citizens, the reduction of health care costs through more efficient manufacturing, and access to better quality drugs through more sophisticated and reliable production processes. Furthermore, the application of continuous manufacturing will enable the U.S. Government, in partnership with pharmaceutical companies, to address current issues such as drug shortages, national emergencies (eg, natural disasters or chemical, biological, radiological, or nuclear threats), the Strategic National Stockpile (ie, improving response time and reducing maintenance costs), and the delivery of critical drugs to distant geographies (eg, forward military bases). The article also provides a detailed example of a critical aspect of continuous manufacturing: the ability to overcome technical challenges encountered by batch technologies.
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31

HAMMOND. "Process Analytical Technology Enabling Continuous Drug Product Manufacturing." Scientia Pharmaceutica 78, no. 3 (2010): 549. http://dx.doi.org/10.3797/scipharm.cespt.8.l09.

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32

VANGENECHTEN. "The Potential of Continuous Processing in Secondary Manufacturing." Scientia Pharmaceutica 78, no. 3 (2010): 562. http://dx.doi.org/10.3797/scipharm.cespt.8.lpes01.

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33

Razavi, Sonia M., James Scicolone, Ronald D. Snee, Ashish Kumar, Johny Bertels, Philippe Cappuyns, Ivo Van Assche, Alberto M. Cuitiño, and Fernando Muzzio. "Prediction of tablet weight variability in continuous manufacturing." International Journal of Pharmaceutics 575 (February 2020): 118727. http://dx.doi.org/10.1016/j.ijpharm.2019.118727.

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34

Chavan, Rahul B., Rajesh Thipparaboina, Balvant Yadav, and Nalini R. Shastri. "Continuous manufacturing of co-crystals: challenges and prospects." Drug Delivery and Translational Research 8, no. 6 (January 19, 2018): 1726–39. http://dx.doi.org/10.1007/s13346-018-0479-7.

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35

Bostijn, N., J. Van Renterghem, B. Vanbillemont, W. Dhondt, C. Vervaet, and T. De Beer. "Continuous manufacturing of a pharmaceutical cream: Investigating continuous powder dispersing and residence time distribution (RTD)." European Journal of Pharmaceutical Sciences 132 (April 2019): 106–17. http://dx.doi.org/10.1016/j.ejps.2019.02.036.

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36

Nasr, Moheb M., Markus Krumme, Yoshihiro Matsuda, Bernhardt L. Trout, Clive Badman, Salvatore Mascia, Charles L. Cooney, et al. "Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice." Journal of Pharmaceutical Sciences 106, no. 11 (November 2017): 3199–206. http://dx.doi.org/10.1016/j.xphs.2017.06.015.

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37

Mesbah, Ali, Joel A. Paulson, Richard Lakerveld, and Richard D. Braatz. "Model Predictive Control of an Integrated Continuous Pharmaceutical Manufacturing Pilot Plant." Organic Process Research & Development 21, no. 6 (June 2017): 844–54. http://dx.doi.org/10.1021/acs.oprd.7b00058.

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38

Liu, Jianfeng, Qinglin Su, Mariana Moreno, Carl Laird, Zoltan Nagy, and Gintaras Reklaitis. "Robust state estimation of feeding–blending systems in continuous pharmaceutical manufacturing." Chemical Engineering Research and Design 134 (June 2018): 140–53. http://dx.doi.org/10.1016/j.cherd.2018.03.017.

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39

Wang, Zilong, M. Sebastian Escotet-Espinoza, and Marianthi Ierapetritou. "Process analysis and optimization of continuous pharmaceutical manufacturing using flowsheet models." Computers & Chemical Engineering 107 (December 2017): 77–91. http://dx.doi.org/10.1016/j.compchemeng.2017.02.030.

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40

Su, Qinglin, Sudarshan Ganesh, Mariana Moreno, Yasasvi Bommireddy, Marcial Gonzalez, Gintaras V. Reklaitis, and Zoltan K. Nagy. "A perspective on Quality-by-Control (QbC) in pharmaceutical continuous manufacturing." Computers & Chemical Engineering 125 (June 2019): 216–31. http://dx.doi.org/10.1016/j.compchemeng.2019.03.001.

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41

Sen, Maitraye, Amanda Rogers, Ravendra Singh, Anwesha Chaudhury, Joyce John, Marianthi G. Ierapetritou, and Rohit Ramachandran. "Flowsheet optimization of an integrated continuous purification-processing pharmaceutical manufacturing operation." Chemical Engineering Science 102 (October 2013): 56–66. http://dx.doi.org/10.1016/j.ces.2013.07.035.

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42

Boukouvala, Fani, and Marianthi G. Ierapetritou. "Surrogate-Based Optimization of Expensive Flowsheet Modeling for Continuous Pharmaceutical Manufacturing." Journal of Pharmaceutical Innovation 8, no. 2 (May 11, 2013): 131–45. http://dx.doi.org/10.1007/s12247-013-9154-1.

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43

Vargas, Jenny M., Sarah Nielsen, Vanessa Cárdenas, Anthony Gonzalez, Efrain Y. Aymat, Elvin Almodovar, Gustavo Classe, Yleana Colón, Eric Sanchez, and Rodolfo J. Romañach. "Process analytical technology in continuous manufacturing of a commercial pharmaceutical product." International Journal of Pharmaceutics 538, no. 1-2 (March 2018): 167–78. http://dx.doi.org/10.1016/j.ijpharm.2018.01.003.

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44

Yadav, Vikramaditya G., and Gregory Stephanopoulos. "ChemInform Abstract: Metabolic Engineering: The Ultimate Paradigm for Continuous Pharmaceutical Manufacturing." ChemInform 45, no. 43 (October 10, 2014): no. http://dx.doi.org/10.1002/chin.201443280.

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45

Robertson, Karen, and Chick Wilson. "A novel open tubular continuous crystalliser: design and evaluation." Acta Crystallographica Section A Foundations and Advances 70, a1 (August 5, 2014): C1182. http://dx.doi.org/10.1107/s2053273314088172.

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The ability to continuously manufacture products can be of huge benefit to industry as it can reduce waste and capital expenditure. Continuous crystallisation has received tepid interest for many years but has come to the fore recently as it holds the potential for a radical transformation in the way crystalline products are manufactured, leading to the development method being embraced by major industries such as pharmaceuticals. In addition to the financial benefits offered by continuous crystallisation over conventional batch methods, a higher level of control over the crystallisation process can also be achieved – allowing improved, more consistent particle attributes to be obtained in the crystallisation process. This control is in part a consequence of the smaller volumes involved in continuous crystallisation, which also has the advantage of reducing any hazards associated with the materials being processed. By using smaller volumes, the mixing efficacy is inherently increased which reduces any disparity between local environments, thereby allowing kinetics to dictate the nature of the products. The EPSRC Centre for Innovative Manufacturing in Continuous Manufacturing and Crystallisation (CMAC [1]) in the UK is a collaborative national initiative to further the knowledge base and understanding of all aspects relating to continuous crystallisation and its use in the manufacturing of crystalline particulate products. In this work we present the design and construction of a novel continuous crystalliser and its evaluation using various model systems such as calcium carbonate (polymorph control [2]) and Bourne reactions (mixing efficacy [3]). The crystalliser will then be used in the co-crystallisation of agrichemical and pharmaceutical compounds with co-formers in an effort to optimise the solid-state properties of these materials such as solubility. Various aspects of the evaluation of the design of the new crystalliser will be presented with reference to these trials, and assessed critically with respect to evolution of this design and potential implementation in manufacturing processes.
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46

DEL RIO ALVAREZ, LUIS ALBERTO, and NURIA SALAZAR SANCHEZ. "TECHNOLOGICAL CHALLENGES IN STERILE PRODUCTOS MANUFACTURING: IS PHARMACEUTICAL INDUSTRY TRAINED?" DYNA 97, no. 2 (March 1, 2022): 135–39. http://dx.doi.org/10.6036/10288.

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Pharmaceutical industry, in addition to assuming the sanitary commitment, as has been demonstrated with the manufacturing of COVID-19 vaccines, must comply with the European Union Good Manufacturing Practices, for that reason it´s subject to a continuous updating demanded by the regulatory requirements. This commitment is even, if possible, greater for injectable drug’s manufacturing companies due to their intrinsic characteristics of safety for the patient, all this together with the maximum productivity objective. A review about the main challenges that the pharmaceutical industry must face for the manufacture of injectable products is carried out, that comprised the incorporation of new biological drugs and advanced therapies into the therapeutic arsenal, the increase in terms of the requirements in regulatory and inspection tasks by health authorities and the leading role that Contract Manufacturing Organisations are playing. On the other hand, issues such as the analytical methods used to evaluate product sterility validity, the impact of possible changes in the different processes and elements, especially in the case of aseptic manufacturing, and the evolution, with the implementation of Sterility and Quality by Design, of sterile products manufacturing science are discussed. Finally, the implementation of disruptive factors such as continuous manufacturing and robotization, which will have, with a high probability, a greater role in the not-so-distant future, is proposed. Key Words: Sterile Drugs, Inspection, Aseptic Manufacturing, Isolators, Good Manufacturing Practices, PAT, Pharmaceutical Industry
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47

Vervaet, Chris, and Jean Paul Remon. "Continuous granulation in the pharmaceutical industry." Chemical Engineering Science 60, no. 14 (July 2005): 3949–57. http://dx.doi.org/10.1016/j.ces.2005.02.028.

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48

Adali, Merve B., Antonello A. Barresi, Gianluca Boccardo, and Roberto Pisano. "Spray Freeze-Drying as a Solution to Continuous Manufacturing of Pharmaceutical Products in Bulk." Processes 8, no. 6 (June 19, 2020): 709. http://dx.doi.org/10.3390/pr8060709.

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Pharmaceutical manufacturing is evolving from traditional batch processes to continuous ones. The new global competition focused on throughput and quality of drug products is certainly the driving force behind this transition which, thus, represents the new challenge of pharmaceutical manufacturing and hence of lyophilization as a downstream operation. In this direction, the present review deals with the most recent technologies, based on spray freeze-drying, that can achieve this objective. It provides a comprehensive overview of the physics behind this process and of the most recent equipment design.
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49

Panikar, Savitha, Jingzhe Li, Varsha Rane, Sean Gillam, Gerardo Callegari, Bogdan Kurtyka, Sau Lee, and Fernando Muzzio. "Integrating sensors for monitoring blend content in a pharmaceutical continuous manufacturing plant." International Journal of Pharmaceutics 606 (September 2021): 120085. http://dx.doi.org/10.1016/j.ijpharm.2020.120085.

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50

Takeuchi, Hirofumi. "Recent Trends in Continuous Pharmaceutical Manufacturing and Expected Contribution of Powder Technology." Journal of the Society of Powder Technology, Japan 58, no. 5 (May 10, 2021): 212–18. http://dx.doi.org/10.4164/sptj.58.212.

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