{"product_id":"chemical-engineering-in-the-pharmaceutical-industry-isbn-9781119285861","title":"Chemical Engineering in the Pharmaceutical Industry","description":"\u003cp\u003e\u003cb\u003eA guide to the development and manufacturing of pharmaceutical products written for professionals in the industry, revised second edition\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eThe revised and updated second edition of \u003ci\u003eChemical Engineering in the Pharmaceutical Industry\u003c\/i\u003e is a practical book that highlights chemistry and chemical engineering. The book’s regulatory quality strategies target the development and manufacturing of pharmaceutically active ingredients of pharmaceutical products. The expanded second edition contains revised content with many new case studies and additional example calculations that are of interest to chemical engineers. The 2\u003csup\u003end\u003c\/sup\u003e Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling.\u003c\/p\u003e \u003cp\u003eThe active pharmaceutical ingredients book puts the focus on the chemistry, chemical engineering, and unit operations specific to development and manufacturing of the active ingredients of the pharmaceutical product. The drug substance operations section includes information on chemical reactions, mixing, distillations, extractions, crystallizations, filtration, drying, and wet and dry milling. In addition, the book includes many applications of process modeling and modern software tools that are geared toward batch-scale and continuous drug substance pharmaceutical operations. This updated second edition:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eContains 30new chapters or revised chapters specific to \u003ci\u003eAPI\u003c\/i\u003e, covering topics including: manufacturing quality by design, computational approaches, continuous manufacturing, crystallization and final form, process safety\u003c\/li\u003e \u003cli\u003eExpanded topics of scale-up, continuous processing, applications of thermodynamics and thermodynamic modeling, filtration and drying\u003c\/li\u003e \u003cli\u003ePresents updated and expanded example calculations\u003c\/li\u003e \u003cli\u003eIncludes contributions from noted experts in the field\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eWritten for pharmaceutical engineers, chemical engineers, undergraduate and graduate students, and professionals in the field of pharmaceutical sciences and manufacturing, the second edition of \u003ci\u003eChemical Engineering in the Pharmaceutical Industry\u003c\/i\u003ef ocuses on the development and chemical engineering as well as operations specific to the design, formulation, and manufacture of drug substance and products.\u003c\/p\u003e \u003cp\u003eList of Contributors xi\u003c\/p\u003e \u003cp\u003ePreface xv\u003c\/p\u003e \u003cp\u003eUnit Conversions xvii\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart I Introduction 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1 Chemical Engineering in the Pharmaceutical Industry: An Introduction 3\u003cbr\u003e \u003ci\u003eDavid J. am Ende and Mary T. am Ende\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2 Current Challenges and Opportunities in the Pharmaceutical Industry 19\u003cbr\u003e \u003ci\u003eJoseph L. Kukura and Michael P. Thien\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart II Mass and Energy Balances 27\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3 Process Safety and Reaction Hazard Assessment 29\u003cbr\u003e \u003ci\u003eWim Dermaut\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4 Calorimetric Approaches to Characterizing Undesired Reactions 61\u003cbr\u003e \u003ci\u003eMegan Roth and Tom Vickery\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5 Case Study of a Borane–THF Explosion 91\u003cbr\u003e \u003ci\u003eDavid J. am Ende and Richard M. Davis\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6 Analytical Aspects for Determination of Mass Balances 115\u003cbr\u003e \u003ci\u003eMatthew Jorgensen\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7 Quantitative Applications of NMR Spectroscopy 133\u003cbr\u003e \u003ci\u003eBrian L. Marquez and R. Thomas Williamson\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart III Reaction Kinetics and Mixing Processes 151\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8 Reaction Kinetics and Characterization 153\u003cbr\u003e \u003ci\u003eUtpal K. Singh, Brandon J. Reizman, Shujauddin M. Changi, Justin L. Burt, and Chuck Orella\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9 Understanding Fundamental Processes in Catalytic Hydrogenation Reactions 191\u003cbr\u003e \u003ci\u003eYongkui Sun and Carl LeBlond\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10 Characterization and First Principles Prediction of API Unit Operations 203\u003cbr\u003e \u003ci\u003eJoe Hannon\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11 Scale-Up of Mass Transfer-Limited Reactions: Fundamentals and a Case Study 227\u003cbr\u003e \u003ci\u003eAyman Allian and Seth Huggins\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12 Scale-Up of Mixing Processes: A Primer 241\u003cbr\u003e \u003ci\u003eFrancis X. McConville and Stephen B. Kessler\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13 Stirred Vessels: Computational Modeling of Multiphase Flows and Mixing 261\u003cbr\u003e \u003ci\u003eAvinash R. Khopkar and Vivek V. Ranade\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart IV Continuous Processing 319\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e14 Process Development and Case Studies of Continuous Reactor Systems for Production of API and Pharmaceutical Intermediates 321\u003cbr\u003e \u003ci\u003eThomas L. LaPorte, Chenchi Wang, and G. Scott Jones\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15 Development and Application of Continuous Processes for the Intermediates and Active Pharmaceutical Ingredients 341\u003cbr\u003e \u003ci\u003eFlavien Susanne\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e16 Design and Selection of Continuous Reactors for Pharmaceutical Manufacturing 367\u003cbr\u003e \u003ci\u003eMartin D. Johnson, Scott A. May, Michael E. Kopach, Jennifer McClary Groh, Timothy Braden, Vaidyaraman Shankarraman, and Jeremy Miles Merritt\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart V Biologics 387\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e17 Chemical Engineering Principles in Biologics: Unique Challenges and Applications 389\u003cbr\u003e \u003ci\u003eSourav Kundu, Vivek Bhatnagar, Naveen Pathak, and Cenk Undey\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart VI Thermodynamics 417\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e18 Applications of Thermodynamics Toward Pharmaceutical Problem Solving 419\u003cbr\u003e \u003ci\u003eAhmad Y. Sheikh, Alessandra Mattei, Raimundo Ho, Moiz Diwan, Thomas Borchardt, Gerald Danzer, Nadine Ding, and Xinmin (Sam) Xu\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e19 A General Framework for Solid–Liquid Equilibria in Pharmaceutical Systems 439\u003cbr\u003e \u003ci\u003eThomas Lafitte, Vasileios Papaioannou, Simon Dufal, and Constantinos C. Pantelides\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e20 Drug Solubility, Reaction Thermodynamics, and Co-Crystal Screening 467\u003cbr\u003e \u003ci\u003eKarin Wichmann, Christoph Loschen, and Andreas Klamt\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e21 Thermodynamic Modeling of Aqueous and Mixed Solvent Electrolyte Systems 493\u003cbr\u003e \u003ci\u003eBenjamin Caudle, Toni E. Kirkes, Cheng-Hsiu Yu, and Chau-Chyun Chen\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e22 Thermodynamics and Relative Solubility Prediction of Polymorphic Systems 505\u003cbr\u003e \u003ci\u003eYuriy A. Abramov and Klimentina Pencheva\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e23 Toward a Rational Solvent Selection for Conformational Polymorph Screening 519\u003cbr\u003e \u003ci\u003eYuriy A. Abramov, Mark Zell, and Joseph F. Krzyzaniak\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart VII Crystallization and Final Form 533\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e24 Crystallization Design and Scale-Up 535\u003cbr\u003e \u003ci\u003eJames Wertman, Robert McKeown, Lotfi Derdour, and Philip Dell’Orco\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e25 Introduction to Chiral Crystallization in Pharmaceutical Development and Manufacturing 569\u003cbr\u003e \u003ci\u003eJose E. Tabora, Shawn Brueggemeier, Michael Lovette, and Jason Sweeney\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e26 Measurement of Solubility and Estimation of Crystal Nucleation and Growth Kinetics 591\u003cbr\u003e \u003ci\u003eNandkishor K. Nere, Manish S. Kelkar, Ann M. Czyzewski, Kushal Sinha, and Evelina B. Kim\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e27 Case Studies On Crystallization Scale-Up 617\u003cbr\u003e \u003ci\u003eNandkishor K. Nere, Moiz Diwan, Ann M. Czyzewski, James C. Marek, Kushal Sinha, and Huayu Li\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e28 Population Balance-Enabled Model for Batch and Continuous Crystallization Processes 635\u003cbr\u003e \u003ci\u003eAjinkya Pandit, Rahul Bhambure, and Vivek V. Ranade\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e29 Solid Form Development for Poorly Soluble Compounds 665\u003cbr\u003e \u003ci\u003eAlessandra Mattei, Shuang Chen, Jie Chen, and Ahmad Y. Sheikh\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e30 Multiscale Assessment of API Physical Properties in the Context of Materials Science Tetrahedron Concept 689\u003cbr\u003e \u003ci\u003eRaimundo Ho, Yujin Shin, Yinshan Chen, Laura Poloni, Shuang Chen, and Ahmad Y. Sheikh\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart VIII Separations, Filtration, Drying and Milling 713\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e31 The Design and Economics of Large-Scale Chromatographic Separations 715\u003cbr\u003e \u003ci\u003eFiroz D. Antia\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e32 Membrane Systems for Pharmaceutical Applications 733\u003cbr\u003e \u003ci\u003eDimitrios Zarkadas and Kamalesh K. Sirkar\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e33 Design of Distillation and Extraction Operations 751\u003cbr\u003e \u003ci\u003eEric M. Cordi\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e34 Case Studies On the Use of Distillation in the Pharmaceutical Industry 787\u003cbr\u003e \u003ci\u003eLaurie Mlinar, Kushal Sinha, Elie Chaaya, Subramanya Nayak, and Andrew Cosbie\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e35 Design of Filtration and Drying Operations 799\u003cbr\u003e \u003ci\u003ePraveen K. Sharma, Saravanababu Murugesan, and Jose E. Tabora\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e36 Filtration Case Studies 833\u003cbr\u003e \u003ci\u003eSeth Huggins, Andrew Cosbie, and John Gaertner\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e37 Drying Case Studies 847\u003cbr\u003e \u003ci\u003eJohn Gaertner, Nandkishor K. Nere, James C. Marek, Shailendra Bordawekar, Laurie Mlinar, Moiz Diwan, and Lei Cao\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e38 Milling Operations in the Pharmaceutical Industry 861\u003cbr\u003e \u003ci\u003eKevin D. Seibert, Paul C. Collins, Carla V. Luciani, and Elizabeth S. Fisher\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart IX Statistical Models, Pat, and Process Modeling Applications 881\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e39 Experimental Design for Pharmaceutical Development 883\u003cbr\u003e \u003ci\u003eGregory S. Steeno\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e40 Multivariate Analysis in API Development 909\u003cbr\u003e \u003ci\u003eJames C. Marek\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e41 Probabilistic Models for Forecasting Process Robustness 919\u003cbr\u003e \u003ci\u003eJose E. Tabora, Jacob Albrecht, and Brendan Mack\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e42 Use of Process Analytical Technology (PAT) in Small Molecule Drug Substance Reaction Development 937\u003cbr\u003e \u003ci\u003eDimitri Skliar, Jeffrey Nye, and Antonio Ramirez\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e43 Process Modeling Applications Toward Enabling Development and Scale-Up: Chemical Reactions 957\u003cbr\u003e \u003ci\u003eAnuj A. Verma, Steven Richter, Brian Kotecki, and Moiz Diwan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart X Manufacturing 971\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e44 Process Scale-Up and Assessment 973\u003cbr\u003e \u003ci\u003eAlan Braem, Jason Sweeney, and Jean Tom\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e45 Scale-Up Do’s and Don’ts 1001\u003cbr\u003e \u003ci\u003eFrancis X. McConville\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e46 Kilo Lab and Pilot Plant Manufacturing 1011\u003cbr\u003e \u003ci\u003eMatthew Casey, Jason Hamm, Melanie Miller, Tom Ramsey, Richard Schild, Andrew Stewart, and Jean Tom\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e47 The Role of Simulation and Scheduling Tools in the Development and Manufacturing of Active Pharmaceutical Ingredients 1037\u003cbr\u003e \u003ci\u003eDemetri Petrides, Doug Carmichael, Charles Siletti, Dimitris Vardalis, Alexandros Koulouris, and Pericles Lagonikos\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart XI Quality by Design and Regulatory 1067\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e48 Scientific Opportunities through Quality by Design 1069\u003cbr\u003e \u003ci\u003eTimothy J. Watson and Roger Nosal\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e49 Applications of Quality Risk Assessment in Quality by Design (QbD) Drug Substance Process Development 1073\u003cbr\u003e \u003ci\u003eAlan Braem and Gillian Turner\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e50 Development of Design Space for Reaction Steps: Approaches and Case Studies for Impurity Control 1091\u003cbr\u003e \u003ci\u003eSrinivas Tummala, Antonio Ramirez, Sushil Srivastava, and Daniel M. Hallow\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIndex 1123\u003c\/p\u003e  \u003cp\u003e\u003cb\u003eDavid J. am Ende, PhD,\u003c\/b\u003e is President of Nalas Engineering Services, Inc. Previously, he was a Research Fellow at Pfizer Inc. in Chemical Research \u0026amp; Development. He has over 25 years's experience in chemical and pharmaceutical process development.  \u003c\/p\u003e\u003cp\u003e\u003cb\u003eMary T. am Ende, PhD,\u003c\/b\u003e is Vice President of Process Development at Lyndra Therapeutics, Inc. Previously, she was a Research Fellow at Pfizer, Inc. in Drug Product Design. She has over 25 years' experience in drug product formulation, process development and computational modeling.   \u003c\/p\u003e\u003cp\u003e\u003cb\u003eA GUIDE TO THE DEVELOPMENT AND MANUFACTURING OF PHARMACEUTICAL PRODUCTS WRITTEN FOR PROFESSIONALS IN THE INDUSTRY, REVISED SECOND EDITION\u003c\/b\u003e  \u003c\/p\u003e\u003cp\u003eThe revised and updated second edition of \u003ci\u003eChemical Engineering in the Pharmaceutical Industry\u003c\/i\u003e is a practical book that highlights chemistry and chemical engineering. The expanded second edition contains revised content with many new case studies and additional example calculations that are of interest to chemical engineers. The second edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API's) and 2) Drug Product Design, Development and Modeling.  \u003c\/p\u003e\u003cp\u003eThe active pharmaceutical ingredients book puts the focus on the chemistry, chemical engineering, and unit operations specific to development and manufacturing of the active ingredients of the pharmaceutical product. The drug substance operations section includes information on chemical reactions, mixing, distillations, extractions, crystallizations, filtration, drying, and wet and dry milling. In addition, the book includes many applications of process modeling and modern software tools that are geared toward batch-scale and continuous drug substance pharmaceutical operations. This updated second edition:  \u003c\/p\u003e\u003cul\u003e \u003cli\u003eContains 30 new chapters or revised chapters specific to API, covering topics including: manufacturing, quality by design, computational approaches, continuous manufacturing, crystallization and final form, process safety\u003c\/li\u003e \u003cli\u003eExpanded topics of scale-up, continuous processing, applications of thermodynamics and thermodynamic modeling, filtration, and drying\u003c\/li\u003e \u003cli\u003ePresents updated and expanded example calculations\u003c\/li\u003e \u003cli\u003eIncludes contributions from noted experts in the field\u003c\/li\u003e \u003c\/ul\u003e  \u003cp\u003eWritten for pharmaceutical engineers, chemical engineers, undergraduate and graduate students, and professionals in the field of pharmaceutical sciences and manufacturing, the second edition of \u003ci\u003eChemical Engineering in the Pharmaceutical Industry\u003c\/i\u003e focuses on the research and development as well as unit operations specific to the scale-up and manufacture of drug substance and intermediates.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47988906000613,"sku":"NP9781119285861","price":367.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781119285861.jpg?v=1761781999","url":"https:\/\/k12savings.com\/es\/products\/chemical-engineering-in-the-pharmaceutical-industry-isbn-9781119285861","provider":"K12savings","version":"1.0","type":"link"}