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Continuous Pharmaceutical Processing

  • Zoltan K Nagy
  • Arwa El Hagrasy
  • Jim Litster
Book
  • 1.2k Downloads

Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 42)

Table of contents

  1. Front Matter
    Pages i-viii
  2. Sudarshan Ganesh, Gintaras V. Reklaitis
    Pages 1-21
  3. Martin D. Johnson, Scott A. May, Michael E. Kopach, Jennifer Mc Clary Groh, Timothy Donald White, Kevin P. Cole et al.
    Pages 23-50
  4. Martin D. Johnson, Scott A. May, Jennifer Mc Clary Groh, Luke P. Webster, Vaidyaraman Shankarraman, Richard D. Spencer et al.
    Pages 51-85
  5. Martin D. Johnson, Scott A. May, Jennifer McClary Groh, Timothy Braden, Richard D. Spencer
    Pages 87-127
  6. Yiqing C. Liu, Zoltan K. Nagy
    Pages 129-192
  7. Qinglin Su, Gintaras V. Reklaitis, Zoltan K. Nagy
    Pages 193-226
  8. Arwa El Hagrasy, Li Ge Wang, Jim Litster
    Pages 269-300
  9. Ibrahim Alaathar, Stefan Heinrich, Ernst-Ulrich Hartge
    Pages 301-359
  10. Vanessa Cárdenas, Juan G. Rosas, Carlos Pinzón, Rodolfo J. Romañach
    Pages 361-393
  11. Qinglin Su, Sudarshan Ganesh, Gintaras V. Reklaitis, Zoltan K. Nagy
    Pages 395-427
  12. Arun Giridhar, Gintaras V. Reklaitis
    Pages 429-440
  13. Martin D. Johnson, Jeffry Niemeier
    Pages 441-476
  14. Jagjit Singh Srai, Ettore Settanni, Parminder Kaur Aulakh
    Pages 477-512
  15. Back Matter
    Pages 537-541

About this book

Introduction

Continuous pharmaceutical manufacturing is currently receiving much interest from industry and regulatory authorities, with the joint aim of allowing rapid access of novel therapeutics and existing medications to the public, without compromising high quality. Research groups from different academic institutions have significantly contributed to this field with an immense amount of published research addressing a variety of topics related to continuous processing. The book is structured to have individual chapters on the different continuous unit operations involved in drug substance and drug product manufacturing. A wide spectrum of topics are covered, including basic principles of continuous manufacturing, applications of continuous flow chemistry in drug synthesis, continuous crystallization, continuous drying, feeders and blenders, roll compaction and continuous wet granulation.The underlying theme for each of these chapters is to present to the reader the recent advances in modeling, experimental investigations and equipment design as they pertain to each individual unit operation. The book also includes chapters on quality by design (QbD) and process analytical technology (PAT) for continuous processing, process control strategies including new concepts of quality-by-control (QbC), real-time process management and plant optimization, business and supply chain considerations related to continuous manufacturing as well as safety guidelines related to continuous chemistry. A separate chapter is dedicated to discussing regulatory aspects of continuous manufacturing, with description of current regulatory environment quality/GMP aspects, as well as regulatory gaps and challenges.

Our aim from publishing this book is to make it a valuable reference for readers interested in this topic, with a desire to gain a fundamental understanding of engineering principles and mechanistic studies utilized in understanding and developing continuous processes. In addition, our advanced readers and practitioners in this field will find that the technical content of Continuous Pharmaceutical Processing is at the forefront of recent technological advances, with coverage of future prospects and challenges for this technology.  


Keywords

Continuous Manufacturing Pharmaceutical Manufacturing Continuous Pharmaceutical Processing Drug Substance Manufacturing Drug Product Manufacturing Quality by Design Quality by Control Process Analytical Technology Pharmaceuticals

Editors and affiliations

  • Zoltan K Nagy
    • 1
  • Arwa El Hagrasy
    • 2
  • Jim Litster
    • 3
  1. 1.Davidson School of Chemical EngineeringPurdue UniversityWest LafayetteUSA
  2. 2.Faculty of PharmacyCairo UniversityCairoEgypt
  3. 3.Department of Chemical and Biochemical EngineeringThe University of SheffieldSheffieldUK

Bibliographic information

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