Skip to main content
Prepare for an exciting September! Each week, we'll examine the latest trends in PAT, offering fresh insights straight from recent conferences. Your perspective matters, so we encourage you to share your thoughts as well. Stay informed, stay engaged, and let's explore these cutting-edge developments together. https://bit.ly/3Xw0X7k
3.16.218.240

Resources: All

Submit a resource

Find a resource

  1. Implementation of ICH Q13 Continuous Manufacturing Guidance

    0.0 out of 5 stars 

    20 Nov 2023 | Workshop | Contributor(s): Rapti Madurawe

    Continuous Manufacturing (CM) BasicsICH Q13 GuidanceFDA ExperienceFuture Directions and Enabling CM of GenericsPharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing - 10/31/2023 | FDA

  2. CDER's Emerging Technology Program

    0.0 out of 5 stars 

    20 Nov 2023 | Workshop | Contributor(s): Thomas O’Connor

    Emerging Technology Program (ETP) OverviewETP TrendsLifecycle of an Emerging TechnologyInteracting with the ETPPharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing - 10/31/2023 | FDA

  3. Lubricant Sensitivity of Direct Compression Grades of Lactose in Continuous and Batch Tableting Process

    0.0 out of 5 stars 

    16 Nov 2023 | Peer-reviewed journal | Contributor(s): Gerald A. Hebbink, Pauline H. M. Janssen, Jurjen H. Kok, Lorenzo Menarini, Federica Giatti, Caterina Funaro, Salvatore Fabrizio Consoli, Bastiaan H. J. Dickhoff

    Modern pharmaceutical manufacturing based on Quality by Design and digitalisation is revolutionising the pharmaceutical industry. Continuous processes are promoted as they increase efficiency and improve quality control. Compared to batch blending, continuous blending is easier to scale and...

  4. Fully automated continuous flow synthesis of 4,5-disubstituted oxazoles

    0.0 out of 5 stars 

    12 Oct 2023 | Peer-reviewed journal | Contributor(s): Baumann M, Baxandale. I, Ley S, Smith G, Tranmer G

    A multipurpose mesofluidic flow reactor capable of producing gram quantities of material has been developed as an automated synthesis platform for the rapid on-demand synthesis of key building blocks and small exploratory libraries. The reactor is configured to provide the maximum flexibility for...

  5. A Comparative Investment Analysis of Batch Versus Continuous Pharmaceutical Manufacturing Technologies

    0.0 out of 5 stars 

    04 Oct 2023 | Peer-reviewed journal | Contributor(s): Clifford V. Rossi

    Purpose This study examines the risks and economics associated with investing in continuous (CM) versus conventional batch manufacturing for production of oral solid dosage pharmaceutical (OSD) products in the USA and abroad. Methods A stochastic net present value (NPV) simulation of brand...

  6. Vendor Case Study: From Batch to Continuous of a Generic Drug: When It Just Makes Sense

    0.0 out of 5 stars 

    04 Oct 2023 | Document | Contributor(s): Cait Boyd

  7. Vendor Case Study: Diverse Ways to Leverage Continuous Manufacturing in Pharmaceutical Development and Production

    0.0 out of 5 stars 

    04 Oct 2023 | Document | Contributor(s): Mike Fazio

  8. Vendor Case Study: Twin Screw Extrusion For Continuous Manufacturing

    0.0 out of 5 stars 

    04 Oct 2023 | Document | Contributor(s): Steve Post

  9. Vendor Case Study: BASF's Formulation Platforms

    0.0 out of 5 stars 

    04 Oct 2023 | Document | Contributor(s): Krizia M. Karry

  10. A Short Journey in Commercial Manufacturing with PCM

    0.0 out of 5 stars 

    04 Oct 2023 | Document | Contributor(s): Sarang Oka

  11. Quality & Regulatory Perspective for Implementation of PCM Costs & Benefits Considerations in the Decision

    0.0 out of 5 stars 

    04 Oct 2023 | Document | Contributor(s): Bikash Chatterjee

  12. Government Initiatives in Advanced Pharmaceutical Mfg.

    0.0 out of 5 stars 

    04 Oct 2023 | Document | Contributor(s): Fernando J. Muzzio

  13. Investing in Continuous vs. Batch Mfg. NPV Simulation Analysis

    0.0 out of 5 stars 

    04 Oct 2023 | Document | Contributor(s): Clifford Rossi

    Modeling the Continuous Manufacturing Investment Decision Under Uncertainty

  14. Unique Requirements to Achieve Business Success with PCM

    0.0 out of 5 stars 

    04 Oct 2023 | Document | Contributor(s): Eric Jayjock

    The unique business requirements needed to achieve business success in CM for innovators, CDMOs and Generics.

  15. PCM Business Case Drivers on Internal & Client Business Cases

    0.0 out of 5 stars 

    04 Oct 2023 | Document | Contributor(s): Doug Hausner

  16. Continuous Manufacturing: The Case for Agility and Flexibility During New Product Commercialization

    0.0 out of 5 stars 

    04 Oct 2023 | Document | Contributor(s): Seth Forster

  17. PCM Business & Commercial Considerations

    0.0 out of 5 stars 

    04 Oct 2023 | Document | Contributor(s): Richard Loughlin

  18. Business Strategy Overview

    0.0 out of 5 stars 

    04 Oct 2023 | Document | Contributor(s): Richard Steiner, Lawrence De Belder

    PCM LandscapePCM BusinessPCM Implementation

  19. Pharmaceutical Continuous Manufacturing: A Guide to Control Strategies for Solid Oral Dose Drugs

    0.0 out of 5 stars 

    23 Aug 2023 | Technical Guides | Contributor(s): Atul Dubey

    Advanced manufacturing technologies like pharmaceutical continuous manufacturing (PCM) can provide potential efficiencies for many medicines and their ingredients, thereby facilitating geographic diversity in manufacturing and supply chain resilience. One of the ways the U.S. Pharmacopeia (USP)...

  20. The Regulatory Landscape Regarding Continuous Manufacturing

    0.0 out of 5 stars 

    17 Aug 2023 | Document | Contributor(s): Adam Fisher

  21. Mitigating Regulatory Challenges to Adoption of Advanced Manufacturing

    0.0 out of 5 stars 

    17 Aug 2023 | Document | Contributor(s): Riley C. Myers

  22. Case study: Commercializing a continuous direct compression product with a novel control strategy

    0.0 out of 5 stars 

    17 Aug 2023 | Document | Contributor(s): Frank Witulski

  23. Effect of batch-to-batch variation of spray dried lactose on the performance of feeders

    0.0 out of 5 stars 

    10 Aug 2023 | Peer-reviewed journal | Contributor(s): Carlota Mendez Torrecillas, Florian Tegel, Ralf Weinekötter, Bernhard Meir, Bastiaan H.J. Dickhoff, Sri Sharath Kulkarni, Pauline H.M. Janssen

    With the emergence of quality by design (QbD), it becomes imperative to gain understanding of the impact of batch-to-batch variability of raw materials on the performance of processes. Feeding is the first unit of operation in a continuous manufacturing line and is critical for the final product...

  24. Impact of material properties and process parameters on tablet quality in a continuous direct compression line

    0.0 out of 5 stars 

    09 Aug 2023 | Peer-reviewed journal | Contributor(s): Pauline H.M. Janssen, Sara Fathollahi Bram Bekaert, Dirk Vanderroost, Timo Roelofs, Valerie Vanhoorne, Chris Vervaet, Bastiaan H.J. Dickhoff

    The current paper shows how excipient properties impact the process parameters and the final tablet properties in a fully integrated continuous direct compression line. Blend properties of low-dose (1% w/w) and high-dose (40% w/w) paracetamol formulations were evaluated...

  25. Process intensification using a semi-continuous mini-blender to support continuous direct compression processing

    0.0 out of 5 stars 

    04 Aug 2023 | Peer-reviewed journal | Contributor(s): Alexandra Lohrmann, Florian Tegel, Muhammad Khalid Maqsood, Yunfei Li Song, Bernhard Meir, Richard Elkes, Bastiaan H.J. Dickhoff, Maarten Jaspers, Timo P. Roelofs

    The production of pharmaceutical tablets is shifting towards continuous manufacturing. Therefore, individual unit operations such as powder blending need to be re-designed. Continuous powder blending has been implemented successfully, but for low-dose formulations this is challenging due to...