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  1. An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US

    20 Nov 2024 | Peer-reviewed journal | Contributor(s): Adam C. Fisher, William Liu, Andreas Schick, Mahesh Ramanadham, Sharmista Chatterjee, Raphael Brykman, Sau L. Lee, Steven Kozlowski, Ashley B. Boam, Stelios C. Tsinontides, Michael Kopcha

    Continuous manufacturing (CM) sends materials directly and continuously to the next step of a process, eliminating hold times and reducing processing times. The potential benefits of CM include improved product quality, reduced waste, lower costs, and increased manufacturing flexibility and...

  2. Increasing Processing Flexibility to Meet Demand

    18 Nov 2024 | Magazine | Contributor(s): Felicity Thomas

    Evolving industry demands are driving the need for greater flexibility and innovation in processing equipment for pharmaceutical manufacturing.

  3. Development and process scaling of repeat mini-blending as a complementary approach to deliver continuous direct compression

    13 Nov 2024 | Peer-reviewed journal | Contributor(s): Martin Prostredny, Hikaru Graeme Jolliffe, Richard Elkes, Khalid Maqsood, Yunfei Li Song, Gavin Reynolds, Bernhard Meir, John Robertson

    Process integration efforts in the pharmaceutical industry have led to an increased interest in Direct Compression, including Continuous Direct Compression. Accurate scale-up of powder blending and prediction of blend Critical Quality Attributes (CQAs) is key. The present work takes a modified...

  4. Demonstrating scalability between two blender types using DEM

    12 Nov 2024 | Peer-reviewed journal | Contributor(s): Peter Boehling, Johan Remmelgas, Mohammadsadegh Salehi, Johannes Poms, Rúben Martins Fraga, Manel Bautista, Johannes G. Khinast, Emmanuela Gavi, Michela Beretta

    Powder blending is a critical step in pharmaceutical manufacturing that can impact product quality such as tablet tensile strength. This study utilized the Discrete Element Method (DEM) to investigate blending in a 5-liter mini-batch and a 2-liter Turbula blender. DEM parameters were calibrated...

  5. Development of a high-fidelity digital twin using the discrete element method for a continuous direct compression process. Part 2. Validation of calibration workflow

    30 Oct 2024 | Peer-reviewed journal | Contributor(s): Peter Toson, Marko Matić, Theresa Hörmann-Kincses, Michela Beretta, Jakob Rehrl, Johannes Poms, Peter Boehling, Thomas O’Connor, Abdollah Koolivand, Geng Tian, Scott M. Krull, Johannes G. Khinast, Johan Remmelgas, Dalibor Jajcevic

    This paper is the second in a series of two that describes the application of discrete element method (DEM) and reduced order modeling to predict the effect of disturbances in the concentration of drug substance at the inlet of a continuous powder mixer on the concentration of the drug...

  6. The role of digital twins in driving sustainability

    29 Oct 2024 | Peer-reviewed journal | Contributor(s): Deborah McElhone, Barrie Cassey, Kamal Abu-Hassan

    As the pharmaceutical sector endeavours to become more sustainable, we hear how digital twins – virtual replicas of systems or products that can help predict performance – are supporting the industry in its efforts.

  7. Development of a high-fidelity digital twin using the discrete element method for a continuous direct compression process. Part 1. Calibration workflow

    24 Oct 2024 | Peer-reviewed journal | Contributor(s): Peter Toson, Marko Matić, Theresa Hörmann-Kincses, Michela Beretta, Jakob Rehrl, Johannes Poms, Thomas O’Connor, Abdollah Koolivand, Geng Tian, Scott M. Krull, Johannes G. Khinast, Dalibor Jajcevic, Johan Remmelgas

    In this work, a high-fidelity digital twin was developed to support the design and testing of control strategies for drug product manufacturing via direct compression. The high-fidelity digital twin platform was based on typical pharmaceutical equipment, materials, and direct compression...

  8. Understanding Powder Behavior in Continuous Feeding: Powder Densification and Screw Layering

    16 Oct 2024 | Peer-reviewed journal | Contributor(s): Sara Fathollahi, Pauline H. M. Janssen, Bram Bekaert, Dirk Vanderroost, Valerie Vanhoorne, Bastiaan H. J. Dickhoff

    Background: Precise continuous feeding of active pharmaceutical ingredients (APIs) and excipients is crucial in a continuous powder-to-tablet manufacturing setup, as any inconsistency can affect the final tablet quality. Method: This study investigated the impact of various materials on the...

  9. Continuous Processing. Continuous Evolution

    08 Oct 2024 | Magazine | Contributor(s): Douglas Hausner

    Continuous processing for small molecule products has been a hot topic for years, but where does the industry stand with it today? We speak with Doug Hausner, Senior Manager, Continuous Manufacturing, Oral Solid Dose, Pharma Services at Thermo Fisher Scientific, to find out.

  10. Continuous micro feeding and mixing of solid dosage forms under vibrational excitation

    08 Oct 2024 | Peer-reviewed journal | Contributor(s): Haifeng Lu, Liang Zhang, Hui Du, Xiaolei Guo, Haifeng Liu

    Continuous manufacturing has intrigued many researchers in the pharmaceutical industry in the post-COVID-19 world. We experimentally studied the discharge characteristics of pharmaceutical excipients under vibrational excitation. The successful accurate dosing and filling of powders at fill...

  11. Investigating screw-agitator speed ratio impact on feeding performance in pharmaceutical manufacturing using discrete element method

    23 Sep 2024 | Peer-reviewed journal | Contributor(s): Paul Van Liedekerke, Thomas De Beer, Ashish Kumar, Luz Nadiezda Naranjo Gómez, Kensaku Matsunami

    In continuous powder handling processes, precise and consistent feeding is crucial for ensuring the quality of the final product. The intermixing effect caused by agitators, which alters the powder’s bulk density, flow rate, and flow patterns, plays a significant role in this process, yet...

  12. Continuous manufacturing: Changing the paradigm in the pharmaceutical manufacturing sector

    23 Sep 2024 | Magazine | Contributor(s): Indu Bhushan

    The author explains how continuous manufacturing is reshaping pharmaceutical production

  13. Pharmaceutical Continuous Manufacturing: Content Uniformity With PAT And RTR

    16 Sep 2024 | Website | Contributor(s): Richard Steiner

    In pharmaceutical continuous manufacturing (PCM), technical solutions ensuring critical quality attributes for content uniformity and unit dose exist for online, in-line, and at-line measurements. Process analytical technology (PAT) allows in-line measurement and control of critical process...

  14. Systematic investigation of the impact of screw elements in continuous wet granulation

    10 Sep 2024 | Peer-reviewed journal | Contributor(s): Katharina Kiricenko, Peter Kleinebudde, Robin Meier

    Twin-screw wet granulation (TSG) is a continuous manufacturing technique either for granules as final dosage form or as an intermediate before tableting or capsule filling. A comprehensive process understanding is required to implement TSG, considering various parameters influencing granule and...

  15. Population balance model enabled digital design and uncertainty analysis framework for continuous crystallization of pharmaceuticals using an automated platform with full recycle and minimal material use

    05 Sep 2024 | Peer-reviewed journal | Contributor(s): Wei-Lee Wu, Zoltan K. Nagy, Yash Barhate, Hemalatha Kilari

    A systematic digital design framework for the development of a digital twin of a continuous crystallization process was presented using the model compound, diphenhydramine hydrochloride (DPH). The key features of the framework include operating space investigations, kinetic parameter estimation...

  16. A modeling and control framework for extraction processes

    05 Sep 2024 | Peer-reviewed journal | Contributor(s): Peter Neugebauer, Jakob Rehrl, Peter Poechlauer, Dirk Kirschneck, Martin Horn, Martin Steinberger, Stephan Sacher, Joscha Boehm, Daniel Moser

    Many continuously operated pharmaceutical process routes have been presented recently. Most of these cover the synthesis of the active pharmaceutical ingredient (API) or solid dosage processing. However, the API purification is also gaining attraction. One widespread and waste-intensive unit...

  17. The Rise of Continuous Manufacturing in Pharma

    13 Aug 2024 | Website | Contributor(s): Editorial Team

    "Mr Indu Bhushan, CEO and Director of STEERLife shares his insights on the transformative journey of continuous manufacturing, and the advanced technologies that have propelled this paradigm shift. He also throws light on how continuous manufacturing has accelerated drug development...

  18. Critical review on the role of excipient properties in pharmaceutical powder-to-tablet continuous manufacturing

    13 Aug 2024 | Peer-reviewed journal | Contributor(s): Sara Fathollahi, Pauline H. M. Janssen, Bastiaan H. J. Dickhoff, Henderik W. Frijlink

    The pharmaceutical industry is gradually changing batch-wise manufacturing processes to continuous manufacturing processes, due to the advantages it has to offer. The final product quality and process efficiency of continuous manufacturing processes is among others impacted by the properties of...

  19. Process intensification of pharmaceutical powder blending at commercial throughputs by utilizing semi-continuous mini-blending

    13 Aug 2024 | Peer-reviewed journal | Contributor(s): Maarten Jaspers, Florian Tegel, Timo P. Roelofs, Fabian Starsich, Yunfei Li Song, Bernhard Meir, Richard Elkes, Bastiaan H.J. Dickhoff

    Process intensification involves the miniaturization of equipment while retaining process throughput and performance. The pharmaceutical industry can benefit from this approach especially during drug product development, where the availability of active pharmaceutical ingredients (API) is often...

  20. Non-destructive detection of disintegrant levels in compressed oral solid dosage forms

    23 Jul 2024 | Peer-reviewed journal | Contributor(s): Sultan, Tipu, Rozin, Enamul Hasan, Dave, Vivek S., Cetinkaya, Cetin

    Quality issues related to compressed oral solid dosage (OSD) forms, such as tablets, arise during the design, development, and production stages, despite established processes and robust production tools. One of the primary quality concerns is the disintegration properties and drug release...

  21. Machine learning framework for extracting micro-viscoelastic and micro-structural properties of compressed oral solid dosage forms

    23 Jul 2024 | Peer-reviewed journal | Contributor(s): Sultan, Tipu, Rozin, Enamul Hasan, Paul, Shubhajit, Tseng, Yin-Chao, Cetinkaya, Cetin

    A compressed pharmaceutical oral solid dosage (OSD) form is a strongly micro-viscoelastic material composite arranged as a network of agglomerated particles due to its constituent powders and their bonding and fractural mechanical properties. An OSD product's Critical Quality Attributes, such as...

  22. Machine learning modeling for ultrasonic quality attribute assessment of pharmaceutical tablets for continuous manufacturing and real-time release testing

    23 Jul 2024 | Peer-reviewed journal | Contributor(s): Sultan, Tipu, Rozin, Enamul Hasan, Paul, Shubhajit, Tseng, Yin-Chao, Dave, Vivek S., Cetinkaya, Cetin

    In in-process quality monitoring for Continuous Manufacturing (CM) and Critical Quality Attributes (CQA) assessment for Real-time Release (RTR) testing, ultrasonic characterization is a critical technology for its direct, non-invasive, rapid, and cost-effective nature. In quality evaluation with...

  23. Orodispersible films: Product transfer from lab-scale to continuous manufacturing

    23 Jul 2024 | Peer-reviewed journal | Contributor(s): Thabet, Yasmin, Breitkreutz, Joerg

    Orodispersible films have been described as new beneficial dosage forms for special patient populations. Due to various production settings, different requirements on film formulations are required for non- continuous and continuous manufacturing. In this study, a continuous coating machine was...

  24. Optimization of Critical Quality Attributes in Tablet Film Coating and Design Space Determination Using Pilot-Scale Experimental Data

    23 Jul 2024 | Peer-reviewed journal | Contributor(s): Liu, Huolong, Meyer, Robert, Flamm, Matthew, Wareham, Laura, Metzger, Matthew, Tantuccio, Anthony, Yoon, Seongkyu

    In this study, the novel high-speed tablet film coating process in the continuous manufacturing was investigated. The influence of key process variables (inlet air flow rate, inlet air temperature, and suspension spray rate) were investigated using a Box-Behnken experimental design method....

  25. Matrix-assisted cocrystallization (MAC) simultaneous production and formulation of pharmaceutical cocrystals by hot-melt extrusion

    23 Jul 2024 | Peer-reviewed journal | Contributor(s): Boksa, Kevin, Otte, Andrew, Pinal, Rodolfo

    A novel method for the simultaneous production and formulation of pharmaceutical cocrystals, matrix-assisted cocrystallization (MAC), is presented. Hot-melt extrusion (HME) is used to create cocrystals by coprocessing the drug and coformer in the presence of a matrix material. Carbamazepine...