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  1. Application of Continuous Flow in Tazobactam Synthesis

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    24 Apr 2024 | Contributor(s): Zhou, Shuhao, Xin, Yunting, Wang, Jiasheng, Wu, Chengjun, Sun, Tiemin

    Tazobactam is a β-lactamase inhibitor. In this work, a combination of continuous flow and batch experiments for the synthesis of tazobactam has been developed. The first three steps and the preparation of the peroxyacetic acid are continuously carried out in the microreactors, which improves the...

  2. Application of Continuous Flow Micromixing Reactor Technology for Synthesis of Benzimidazole Drugs

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    24 Apr 2024 | Contributor(s): Reddy, Gunupati Sharathchandra, Reddy, Narra Santosh, Manudhane, Kushal, Rama Krishna, Medisetti Venkata, Ramachandra, Kopparapu Janardana Sarma, Gangula, Srinivas

    Synthesis of pharmaceutically active compounds by employing continuous flow micromixing reactor technology is an interesting research area. In this article we describe the synthesis of benzimidazole core drugs, such as lansoprazole (1a), pantaprazole (1b), and rabeprazole (1c) by using a...

  3. A Focused and Flexible Analytical Strategy is Key to Unlocking the Benefits of Continuous Manufacturing

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    11 Apr 2024 | Website | Contributor(s): Bikash Chatterjee

    Continuous manufacturing processes promise shorter manufacturing cycle times without the need for intermediate storage, sampling testing and release of intermediate process steps, and shorter product release times through the intelligent application of in-line and at-line testing strategies....

  4. A Continuous Process for Manufacturing Apremilast. Part II: Process Characterization to Establish a Parametric Control Strategy

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    03 Apr 2024 | Peer-reviewed journal | Contributor(s): Griffin, Daniel J., Avci, Nadide Hazal, Sarkar, Nandini, Fostinis, James D., Klitzing, Nicholas, Murray, James I., Wimalasinghe, Rasangi, Spada, Simone, Zeng, Alicia, Beaver, Matthew G., Hsieh, Hsiao-Wu

    This is Part II of a series on the development and characterization of an integrated continuous manufacturing (CM) process developed for the penultimate step in the synthesis of the drug substance Apremilast (Otezla). Part I gives the development history and highlights the achieved process...

  5. Innovation and Continuous Improvement in Pharmaceutical Manufacturing

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    28 Mar 2024 | Document | Contributor(s): Ajaz Hussain (Chairperson) Raafat Fahmy (CVM), William Bargo (CVM), Robert Coleman, Robert (ORA), Elise Murphy (ORA), Frank Holcombe Jr (CDER), Chris Watts (CDER), See Lam (CDER), Jon Clark (CDER), Christopher Joneckis (CBER), John Dietrick (CDER), Diana Kolaitis (ORA), Vilayat Sayeed (CDER), Mai Huynh (CVM), Norman Schmuff (CDER), Andrew Chang (CBER)

    The PAT Team and Manufacturing Science Working Group Report: A Summary of Learning, Contributions and Proposed Next Steps for Moving towards the "Desired State" of Pharmaceutical Manufacturing in the 21st Century

  6. A Perspective on Quality by Design: A Preclinical Opportunity

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    28 Mar 2024 | Document | Contributor(s): Ajaz S. Hussain

  7. A Shared Vision for Pharmaceutical Development and Manufacturing in the 21st Century: Contributions of the PAT Initiative

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    28 Mar 2024 | Document | Contributor(s): Ajaz S. Hussain

  8. The Subcommittee on Process Analytical Technologies (PAT): Closing Remarks

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    28 Mar 2024 | Document | Contributor(s): Ajaz S. Hussain

  9. The Process Analytical Technology Initiative: PAT and the Pharmacopeias

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    28 Mar 2024 | Document | Contributor(s): Ajaz S. Hussain

    The PAT Initiative A part of the Pharmaceutical Quality for the 21st Century Initiative  PAT and the USP Opportunities for the USP to support the PAT Framework

  10. Utilizing PAT to Monitor and Control Bulk Biotech Processes

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    27 Mar 2024 | Document | Contributor(s): Rick E. Cooley

    1.What is and isn’t PAT? 2.Implementing PAT in Manufacturing: What does it take? 3.Characteristics of bulk, biotech API processes 4.Why PAT? 5.Review of PAT technologies utilized 6.PAT application examples

  11. Continuous Manufacturing: Many Want It, But Here's Why Few Have It

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    20 Feb 2024 | Website | Contributor(s): Ioanna Deni

    Continuous manufacturing remains a key objective among bioprocessing professionals. While continuous bioprocessing isn’t a new concept, having been applied in the production of both old and new products, significant technological advancements set the stage for its wider adoption.

  12. Influence of refilling on dosing accuracy of loss-in-weight powder feeders in continuous manufacturing

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    19 Feb 2024 | Peer-reviewed journal | Contributor(s): Jochen Thies, Peter Kleinebudde, Fabiola N. Santamaría Alvarez

    Continuous manufacturing is a novel concept to produce high quality drug products. The manufacture of solid dosage forms starts with the feeding of materials, which is consider a critical step because it could have a high influence on the quality of the final product. Therefore, this unit...

  13. Compact NMR Spectroscopy for Automated Continuous-Flow Production of Chemicals and Pharmaceuticals (On-Demand)

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    31 Jan 2024 | Seminars | Contributor(s): Klas Meyer

    Chemical companies are under constant pressure to improve productivity while cutting costs. Flexible and modular chemical plants can produce high-quality products using multi-purpose equipment with short downtimes, reducing time to market for new products. Intensified continuous production...

  14. Continuous Manufacturing for Pharmaceutical Solid Dosage Forms (On-Demand)

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    31 Jan 2024 | Seminars | Contributor(s): Atul Dubey, Fernando Muzzio, Gerardo Callegari, Lucy L. Botros, Ravendra Singh, James Scicolone, Andres Roman, Sonia Modarres Razavi

    Course Description: This self-paced curriculum contains fourteen self-paced modules and three recordings of live virtual education on Pharmaceutical Continuous Manufacturing (PCM). Learners will have access to the following: A recording of the introductory session covering topics such as...

  15. USP Excipients Workshop: Understanding the Impact of Material Attributes on Product Quality for Continuous Manufacturing (On-Demand)

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    31 Jan 2024 | Seminars | Contributor(s): Thomas O’Connor

    For continuous manufacturing processes, the impact of variation in material attributes on material feeding and process dynamics should be characterized and appropriate controls implemented if needed.

  16. Advancing tablet lubrication: A systematic comparison of feed frame lubrication and internal lubrication

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    26 Jan 2024 | Peer-reviewed journal | Contributor(s): Jens Bartsch, Markus Thommes, Christopher Mathias, René Brands

    For the continuous manufacturing of tablets, internal lubrication is often utilized. Here, lubricant is added to a pre-blend in an additional blending step. However, over-lubrication may occur, with a negative impact on the tablet quality. This study consequently focuses on the...

  17. Five key factors to consider when selecting a granulation system for tablet manufacturing

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    23 Jan 2024 | Magazine | Contributor(s): Fi Forrest

    Granulation is a vital process in pharmaceutical dosage forms, transforming powders into granules. Michael Schupp from Gerteis - specialists in dry granulation systems for the pharmaceutical industry - discusses what you should be looking for when choosing your granulation method. 

  18. New gravimetric dosing device for Continuous Manufacturing

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    18 Jan 2024 | Website | Contributor(s): VX management

    "So far, it is mainly Loss in Weight feeders (LIW) that are used for this purpose, especially in the pharmaceutical industry, as they can handle smaller flow rates accurately enough. The mechanical concept of these is decades old and despite miniaturisation and improvements at detail...

  19. Liquid API feeding in pharmaceutical HME: Novel options in solid dosage manufacturing

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    18 Jan 2024 | Peer-reviewed journal | Contributor(s): Simone Eder, Aygün Doğan, Johannes Khinast, Stephan Sacher, Martin Spoerk, Lisa Kuchler

    Hot melt extrusion (HME) is a common unit operation. It is broadly applicable in the pharmaceutical industry and can be implemented in a continuous manufacturing line. However, the conventional way of active pharmaceutical ingredient (API) feeding with a pre-blend consisting of a powdered API...

  20. USP-ID

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    04 Jan 2024 | Website | Contributor(s): Molly Ferns

    USP-ID, delivered by Mestrelab Research, is a one-click, automated software solution for identifying, quantifying and labelling a broad range of chemical components in both simple solutions and complex mixtures by qNMR.

  21. Quality & Regulatory Solutions for PAT in Continuous Manufacturing

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    04 Jan 2024 | Magazine | Contributor(s): Gabriella Dahlgren, Kevin A. Macias, Antonio R. Moreira, Duncan R. Thompson, Christoph Herwig, Robert Dream

    Process analytical technology (PAT) is perceived as the main enabler for a robust control strategy with continuous manufacturing (CM) because process analytical technology can aid in implementing continuous manufacturing throughout the entire life cycle. This article discusses quality and...

  22. Batch vs. continuous direct compression – a comparison of material processability and final tablet quality

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    03 Jan 2024 | Peer-reviewed journal | Contributor(s): S. Fathollahi, D. Vanderroost, T. Roelofs, B.H.J. Dickhoff, C. Vervaet, V. Vanhoorne, B. Bekaert, P.H.M. Janssen

    In this study, an in-depth comparison was made between batch and continuous direct compression using similar compression set-ups. The overall material processability and final tablet quality were compared and evaluated. Correlations between material properties, process parameters and final...

  23. E-factor analysis of a pilot plant for end-to-end integrated continuous manufacturing (ICM) of pharmaceuticals

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    06 Dec 2023 | Peer-reviewed journal | Contributor(s): Stephen C. Born, Wei Wu, Khrystyna Shvedova, Ridade Sayin, Bhakti S. Halkude, Federica Casati, Anjana Ramnath, Paul Hermant, Bayan Takizawa, Thomas F. O'Connor, Xiaochuan Yang, Sukumar Ramanujamd, Salvatore Mascia, Christopher J. Testa, Chuntian Hu

    Most drugs are still manufactured by time-intensive and cost-inefficient batch processes; however, the pharmaceutical industry is undergoing a transition to continuous processes to benefit from the reduced lead time, cost, and footprint and improved quality associated with this new methodology....

  24. Sustainability case studies on the use of continuous manufacturing in pharmaceutical production

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    06 Dec 2023 | Peer-reviewed journal | Contributor(s): Mark S. Kerr, Kevin P. Cole

    Continuous processing is now commonly used in the manufacturing of fine chemicals including agrochemicals and pharmaceuticals. Datasets are now available, including some on environmental sustainability aspects, that enable more direct comparison between related batch and flow processes....

  25. MOOC 1 Introduction to Continuous Manufacturing

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    29 Nov 2023 | Teaching Materials | Contributor(s): RCPE