Pharmaceutical Process Development

Pharmaceutical Process Development PDF Author: John Blacker
Publisher: Royal Society of Chemistry
ISBN: 1849733074
Category : Science
Languages : en
Pages : 375

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Book Description
Pharmaceutical process research and development is an exacting, multidisciplinary effort but a somewhat neglected discipline in the chemical curriculum. This book presents an overview of the many facets of process development and how recent advances in synthetic organic chemistry, process technology and chemical engineering have impacted on the manufacture of pharmaceuticals. In 15 concise chapters the book covers such diverse subjects as route selection and economics, the interface with medicinal chemistry, the impact of green chemistry, safety, the crucial role of physical organic measurements in gaining a deeper understanding of chemical behaviour, the role of the analyst, new tools and innovations in reactor design, purification and separation, solid state chemistry and its role in formulation. The book ends with an assessment of future trends and challenges. The book provides a valuable overview of: both early and late stage chemical development, how safe and scaleable synthetic routes are designed, selected and developed, the importance of the chemical engineering, analytical and manufacturing interfaces, the key enabling technologies, including catalysis and biocatalysis, the importance of the green chemical perspective and solid form issues. The book, written and edited by experts in the field, is a contemporary, holistic treatise, with a logical sequence for process development and mini-case histories within the chapters to bring alive different aspects of the process. It is completely pharmaceutical themed, encompassing all essential aspects, from route and reagent selection to manufacture of the active compound. The book is aimed at both graduates and postgraduates interested in a career in the pharmaceutical industry. It informs them about the breadth of the work carried out in chemical research and development departments, and gives them a feel for the challenges involved in the job. The book is also of value to academics who often understand the drug discovery arena, but have far less appreciation of the drug development area, and are thus unable to advise their students about the relative merits of careers in chemical development versus discovery.

Pharmaceutical Process Development

Pharmaceutical Process Development PDF Author: John Blacker
Publisher: Royal Society of Chemistry
ISBN: 1849733074
Category : Science
Languages : en
Pages : 375

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Book Description
Pharmaceutical process research and development is an exacting, multidisciplinary effort but a somewhat neglected discipline in the chemical curriculum. This book presents an overview of the many facets of process development and how recent advances in synthetic organic chemistry, process technology and chemical engineering have impacted on the manufacture of pharmaceuticals. In 15 concise chapters the book covers such diverse subjects as route selection and economics, the interface with medicinal chemistry, the impact of green chemistry, safety, the crucial role of physical organic measurements in gaining a deeper understanding of chemical behaviour, the role of the analyst, new tools and innovations in reactor design, purification and separation, solid state chemistry and its role in formulation. The book ends with an assessment of future trends and challenges. The book provides a valuable overview of: both early and late stage chemical development, how safe and scaleable synthetic routes are designed, selected and developed, the importance of the chemical engineering, analytical and manufacturing interfaces, the key enabling technologies, including catalysis and biocatalysis, the importance of the green chemical perspective and solid form issues. The book, written and edited by experts in the field, is a contemporary, holistic treatise, with a logical sequence for process development and mini-case histories within the chapters to bring alive different aspects of the process. It is completely pharmaceutical themed, encompassing all essential aspects, from route and reagent selection to manufacture of the active compound. The book is aimed at both graduates and postgraduates interested in a career in the pharmaceutical industry. It informs them about the breadth of the work carried out in chemical research and development departments, and gives them a feel for the challenges involved in the job. The book is also of value to academics who often understand the drug discovery arena, but have far less appreciation of the drug development area, and are thus unable to advise their students about the relative merits of careers in chemical development versus discovery.

The Management of Chemical Process Development in the Pharmaceutical Industry

The Management of Chemical Process Development in the Pharmaceutical Industry PDF Author: Derek Walker
Publisher: John Wiley & Sons
ISBN: 0470259507
Category : Medical
Languages : en
Pages : 424

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Book Description
Here is a practical guide that not only presents insights into the organization and management of the disciplines involved in chemical process development but also provides basic knowledge of these disciplines, enabling process development practitioners to recognize and assimilate them in their work. This book illustrates practical considerations through many examples of the successful direction and integration of the activities of chemists, analysts, chemical engineers, and biologists, as well as safety, regulatory, and environmental professionals in productive teams. Moreover, this reference provides guidance on: Directing and carrying out specific tasks and courses of action Making and communicating clear and achievable decisions Solving problems on the spot Managing the administrative aspects of chemical process development The author, Dr. Derek Walker, has directed chemical process development work for four decades, combining firsthand chemical synthesis experience with many other disciplines needed to create chemical processes. You will benefit from his advice and unique insights into: Understanding the workings of matrix organizations Defining missions and creating action plans Developing interdisciplinary approaches to problem solving Holding review meetings, revising goals, and motivating staff Prioritizing programs and responses to emergencies In addition, you'll learn how successful chemists, in collaboration with other disciplines, define the best (green) chemistry for process scale-up, including accommodating FDA requirements in the last process steps and addressing safety and environmental matters early in their work. Case studies provide incisive perspective on these issues. A chapter on recognizing and patenting intellectual property emphasizes the importance of comprehensive literature surveys and understanding invention. A chapter on the future challenges you to think beyond narrow constraints and explore new horizons.

Principles of Process Research and Chemical Development in the Pharmaceutical Industry

Principles of Process Research and Chemical Development in the Pharmaceutical Industry PDF Author: Oljan Repic
Publisher: Wiley-Interscience
ISBN:
Category : Medical
Languages : de
Pages : 248

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Book Description
Dr. Oljan Repic clearly explains the goals and basic principles of chemical development. He explores the crucial aspects of a new process that must be considered when scaling up a research synthesis to industrial levels. And, with the help of many case studies and vignettes, he delineates each phase of the development process. Key topics include qualities of an ideal process, techniques for minimizing impurities, criteria for cost-effective synthesis of enantiopure compounds by resolutions, asymmetric synthesis and the "chiral pool" strategy, synthesis for labeling substances with hydrogen or carbon isotopes, and new drug registration requirements. This book is an invaluable reference for professionals as well as an important source of guidance and inspiration for young chemists considering entering the field.

Practical Process Research and Development

Practical Process Research and Development PDF Author: Neal G. Anderson
Publisher: Academic Press
ISBN: 0123865387
Category : Science
Languages : en
Pages : 489

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Book Description
Designed to provide a comprehensive, step-by-step approach to organic process research and development in the pharmaceutical, fine chemical, and agricultural chemical industries, this book describes the steps taken, following synthesis and evaluation, to bring key compounds to market in a cost-effective manner. It describes hands-on, step-by-step, approaches to solving process development problems, including route, reagent, and solvent selection; optimising catalytic reactions; chiral syntheses; and "green chemistry." Second Edition highlights:• Reflects the current thinking in chemical process R&D for small molecules• Retains similar structure and orientation to the first edition. • Contains approx. 85% new material• Primarily new examples (work-up and prospective considerations for pilot plant and manufacturing scale-up)• Some new/expanded topics (e.g. green chemistry, genotoxins, enzymatic processes)• Replaces the first edition, although the first edition contains useful older examples that readers may refer to - Provides insights into generating rugged, practical, cost-effective processes for the chemical preparation of "small molecules" - Breaks down process optimization into route, reagent and solvent selection, development of reaction conditions, workup, crystallizations and more - Presents guidelines for implementing and troubleshooting processes

Biocatalysis for Green Chemistry and Chemical Process Development

Biocatalysis for Green Chemistry and Chemical Process Development PDF Author: Junhua (Alex) Tao
Publisher: John Wiley & Sons
ISBN: 1118028295
Category : Technology & Engineering
Languages : en
Pages : 494

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Book Description
This book describes recent progress in enzyme-driven green syntheses of industrially important molecules. The first three introductory chapters overview recent technological advances in enzymes and cell-based transformations, and green chemistry metrics for synthetic efficiency. The remaining chapters are directed to case studies in biotechnological production of pharmaceuticals (small molecules, natural products and biologics), flavors, fragrance and cosmetics, fine chemicals, value-added chemicals from glucose and biomass, and polymeric materials. The book is aimed to facilitate the industrial applications of this powerful and emerging green technology, and catalyze the advancement of the technology itself.

Chemical Process Technology

Chemical Process Technology PDF Author: Jacob A. Moulijn
Publisher: John Wiley & Sons
ISBN: 1118570758
Category : Technology & Engineering
Languages : en
Pages : 691

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Book Description
With a focus on actual industrial processes, e.g. the production of light alkenes, synthesis gas, fine chemicals, polyethene, it encourages the reader to think “out of the box” and invent and develop novel unit operations and processes. Reflecting today’s emphasis on sustainability, this edition contains new coverage of biomass as an alternative to fossil fuels, and process intensification. The second edition includes: New chapters on Process Intensification and Processes for the Conversion of Biomass Updated and expanded chapters throughout with 35% new material overall Text boxes containing case studies and examples from various different industries, e.g. synthesis loop designs, Sasol I Plant, Kaminsky catalysts, production of Ibuprofen, click chemistry, ammonia synthesis, fluid catalytic cracking Questions throughout to stimulate debate and keep students awake! Richly illustrated chapters with improved figures and flow diagrams Chemical Process Technology, Second Edition is a comprehensive introduction, linking the fundamental theory and concepts to the applied nature of the subject. It will be invaluable to students of chemical engineering, biotechnology and industrial chemistry, as well as practising chemical engineers. From reviews of the first edition: “The authors have blended process technology, chemistry and thermodynamics in an elegant manner... Overall this is a welcome addition to books on chemical technology.” – The Chemist “Impressively wide-ranging and comprehensive... an excellent textbook for students, with a combination of fundamental knowledge and technology.” – Chemistry in Britain (now Chemistry World)

Process Development

Process Development PDF Author: Jerry Carr-Brion
Publisher: Walter de Gruyter GmbH & Co KG
ISBN: 3110717913
Category : Technology & Engineering
Languages : en
Pages : 206

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Book Description
Written by an experienced professional, this book introduces chemists to process development, using examples from the pharmaceutical, agrochemical and fragrance industries. The focus is on small molecules rather than biomolecules, and on relatively small-scale production rather than bulk petrochemicals. The coverage is broad, going from initial route development, through pilot plant operations, to full-scale production.

Handbook for Chemical Process Research and Development

Handbook for Chemical Process Research and Development PDF Author: Wenyi Zhao
Publisher: CRC Press
ISBN: 1315350203
Category : Medical
Languages : en
Pages : 864

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Book Description
The Handbook for Chemical Process Research and Development focuses on developing processes for chemical and pharmaceutical industries. Forty years ago there were few process research and development activities in the pharmaceutical industry, partially due to the simplicity of the drug molecules. However, with the increasing structural complexity, especially the introduction of chiral centers into the drug molecules and strict regulations set by the EMA and FDA, process R&D has become one of the critical departments for pharmaceutical companies. This book assists with the key responsibility of process chemists to develop chemical processes for manufacturing pharmaceutical intermediates and final drug substances for clinical studies and commercial production.

Industrial Chemical Process Analysis and Design

Industrial Chemical Process Analysis and Design PDF Author: Mariano Martín Martín
Publisher: Elsevier
ISBN: 0081012330
Category : Technology & Engineering
Languages : en
Pages : 495

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Book Description
Industrial Chemical Process Analysis and Design uses chemical engineering principles to explain the transformation of basic raw materials into major chemical products. The book discusses traditional processes to create products like nitric acid, sulphuric acid, ammonia, and methanol, as well as more novel products like bioethanol and biodiesel. Historical perspectives show how current chemical processes have developed over years or even decades to improve their yields, from the discovery of the chemical reaction or physico-chemical principle to the industrial process needed to yield commercial quantities. Starting with an introduction to process design, optimization, and safety, Martin then provides stand-alone chapters—in a case study fashion—for commercially important chemical production processes. Computational software tools like MATLAB®, Excel, and Chemcad are used throughout to aid process analysis. - Integrates principles of chemical engineering, unit operations, and chemical reactor engineering to understand process synthesis and analysis - Combines traditional computation and modern software tools to compare different solutions for the same problem - Includes historical perspectives and traces the improving efficiencies of commercially important chemical production processes - Features worked examples and end-of-chapter problems with solutions to show the application of concepts discussed in the text

Chemical Engineering and Chemical Process Technology - Volume V

Chemical Engineering and Chemical Process Technology - Volume V PDF Author: Ryzhard Pohorecki
Publisher: EOLSS Publications
ISBN: 1848264003
Category :
Languages : en
Pages : 338

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Book Description
Chemical Engineering and Chemical Process Technology is a theme component of Encyclopedia of Chemical Sciences, Engineering and Technology Resources in the global Encyclopedia of Life Support Systems (EOLSS), which is an integrated compendium of twenty Encyclopedias. Chemical engineering is a branch of engineering, dealing with processes in which materials undergo changes in their physical or chemical state. These changes may concern size, energy content, composition and/or other application properties. Chemical engineering deals with many processes belonging to chemical industry or related industries (petrochemical, metallurgical, food, pharmaceutical, fine chemicals, coatings and colors, renewable raw materials, biotechnological, etc.), and finds application in manufacturing of such products as acids, alkalis, salts, fuels, fertilizers, crop protection agents, ceramics, glass, paper, colors, dyestuffs, plastics, cosmetics, vitamins and many others. It also plays significant role in environmental protection, biotechnology, nanotechnology, energy production and sustainable economical development. The Theme on Chemical Engineering and Chemical Process Technology deals, in five volumes and covers several topics such as: Fundamentals of Chemical Engineering; Unit Operations – Fluids; Unit Operations – Solids; Chemical Reaction Engineering; Process Development, Modeling, Optimization and Control; Process Management; The Future of Chemical Engineering; Chemical Engineering Education; Main Products, which are then expanded into multiple subtopics, each as a chapter. These five volumes are aimed at the following five major target audiences: University and College students Educators, Professional practitioners, Research personnel and Policy analysts, managers, and decision makers and NGOs.