Skip to main content
Join CMKC members for a complimentary virtual event on December 10, 11am ET: CM MythBusters: https://bit.ly/3YXJynA. This is a fantastic opportunity to connect, collaborate, and debunk common myths about continuous manufacturing!
52.14.88.137

Resources: All

Submit a resource

Find a resource
  1. nearinfraredspectroscopy x
  2. continuousmanufacturing x
  3. regulatory x
  4. processanalyticaltechnology x

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

    0.0 out of 5 stars 

    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. The role of digital twins in driving sustainability

    0.0 out of 5 stars 

    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.

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

    0.0 out of 5 stars 

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

    The author explains how continuous manufacturing is reshaping pharmaceutical production

  4. The Rise of Continuous Manufacturing in Pharma

    0.0 out of 5 stars 

    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...

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

    0.0 out of 5 stars 

    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...

  6. The Use of a Closed Feed Frame for the Development of Near-Infrared Spectroscopic Calibration Model to Determine Drug Concentration

    0.0 out of 5 stars 

    23 Jul 2024 | Peer-reviewed journal | Contributor(s): Movilla-Meza, Nathaly A., Sierra-Vega, Nobel O., Alvarado-Hernández, Bárbara B., Méndez, Rafael, Romañach, Rodolfo J.

    Purpose: This study evaluates the use of the closed feed frame as a material sparing approach to develop near-infrared (NIR) spectroscopic calibration models for monitoring blend uniformity. The effect of shear induced by recirculation on NIR spectra was also studied. Methods: Calibration models...

  7. Continuous Manufacturing in the Pharmaceutical Industry: Enhancing Drug Production

    0.0 out of 5 stars 

    23 Jul 2024 | Website | Contributor(s): Timmerman, Siebe

    A significant shift towards continuous manufacturing (CM) is currently underway in the pharmaceutical industry. Unlike the more commonly used batch processing, CM operates continuously. This method potentially offers increased efficiency, agility, and flexibility in the manufacturing of drug...

  8. Cleaning of direct compression continuous manufacturing equipment through displacement of API residues by excipients

    0.0 out of 5 stars 

    23 Jul 2024 | Peer-reviewed journal | Contributor(s): Patel, Dhavalkumar S, Méndez, Rafael, Romañach, Rodolfo J

    This feasibility study evaluates a cleaning process designed to avoid the use of detergents and reduce operator exposure to the active pharmaceutical ingredient (API). The continuous manufacturing equipment was cleaned using excipients to displace ibuprofen residues from the system. The cleaning...

  9. Control oriented modeling of twin-screw granulation in the ConsiGmaTM-25 production plant

    0.0 out of 5 stars 

    09 Jul 2024 | Peer-reviewed journal | Contributor(s): Johannes Khinast, Martin Horn, Jakob Rehrl, Selma Celikovic, Johannes Poms

    ConsiGmaTM-25 is a continuous production plant integrating a twin-screw granulation, fluid bed drying, granule conditioning, and a tableting unit. The particle size distribution (PSD), active pharmaceutical ingredient (API) content, and liquid content of wet granules after twin-screw...

  10. Implementation of a fully integrated continuous manufacturing line for direct compression and coating at a commercial pharmaceutical facility – Part 1: Operational considerations and control strategy

    0.0 out of 5 stars 

    25 Jun 2024 | Peer-reviewed journal | Contributor(s): Conway, Stephen L., Rosas, Juan G., Overton, Paul, Tugby, Neil, Cryan, Phillip, Witulski, Frank, Hurley, Samantha, Wareham, Laura, Tantuccio, Anthony, Ramasamy, Manoharan, Lalloo, Anita, Gibbs, Mason, Meyer, Robert F.

    We implement a fully integrated continuous manufacturing (CM) line for direct compression and coating of a pharmaceutical oral solid dosage form in a commercial production facility. In this first paper of a two-part series, we describe process design and operational choices made to introduce CM...

  11. Implementation of a fully integrated CM direct compression and coating process at a commercial pharmaceutical facility - Part 2: PAT and RTD results for normal operational conditions batches.

    0.0 out of 5 stars 

    25 Jun 2024 | Peer-reviewed journal | Contributor(s): Rosas, JG, Brush, P, Thompson, B, Miller, C, Overton, P, Tugby, N, Stoliarskaia, D, Hurley, S, Ramasamy, M, Conway, SL

    This is the second of two articles detailing the continuous manufacturing (CM) development and implementation activities for an marketed product which have been realized in novel, qualified equipment, using validated control strategy elements to enable manufacture of batches under current good...

  12. Development of a Continuous Flow Grignard Reaction to Manufacture a Key Intermediate of Ipatasertib

    0.0 out of 5 stars 

    25 Jun 2024 | Peer-reviewed journal | Contributor(s): Kaldre, Dainis, Stocker, Severin, Linder, David, Reymond, Helena, Schuster, Andreas, Lamerz, Jens, Hildbrand, Stefan, Püntener, Kurt, Berry, Malcolm, Sedelmeier, Jörg

    This article outlines the development of a continuous flow process for the manufacture of a key intermediate of the active pharmaceutical ingredient ipatasertib for the treatment of metastatic castration-resistant prostate cancer and triple-negative metastatic breast cancer. The reaction sequence...

  13. Embracing continuous manufacturing in the pharmaceutical industry

    0.0 out of 5 stars 

    03 Jun 2024 | Website | Contributor(s): Joelle Anselmo

    "Drugmakers have been slow to adopt the production process, which experts say can streamline operations, boost data quality and reduce time to market."

  14. Embracing continuous manufacturing in the pharmaceutical industry

    0.0 out of 5 stars 

    03 Jun 2024 | Website | Contributor(s): Joelle Anselmo

    "Drugmakers have been slow to adopt the production process, which experts say can streamline operations, boost data quality and reduce time to market."

  15. Innovation and Continuous Improvement in Pharmaceutical Manufacturing

    0.0 out of 5 stars 

    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

  16. Innovation and Continuous Improvement in Pharmaceutical Manufacturing

    0.0 out of 5 stars 

    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

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

    0.0 out of 5 stars 

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

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

    0.0 out of 5 stars 

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

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

    0.0 out of 5 stars 

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

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

    0.0 out of 5 stars 

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

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

    0.0 out of 5 stars 

    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

  22. Utilizing PAT to Monitor and Control Bulk Biotech Processes

    0.0 out of 5 stars 

    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

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

    0.0 out of 5 stars 

    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...

  24. Quality & Regulatory Solutions for PAT in Continuous Manufacturing

    0.0 out of 5 stars 

    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...

  25. MOOC 1 Introduction to Continuous Manufacturing

    0.0 out of 5 stars 

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