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Process Chemistry in the Pharmaceutical Industry

Process Chemistry in the Pharmaceutical Industry PDF Author: Kumar Gadamasetti
Publisher: CRC Press
ISBN: 9780824719814
Category : Medical
Languages : en
Pages : 514

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Book Description
Providing guidance for chemists and other scientists entering pharmaceutical discovery and development, this up-to-the-minute reference presents contributions from an international group of nearly 50 renowned researchers—offering a solid grounding in synthetic and physical organic chemistry, and clarifying the roles of various specialties in the development of new drugs. Featuring over 1000 references, tables, and illustrations, Process Chemistry in the Pharmaceutical Industry is sure to find its way to the bookshelves of organic, physical, analytical, process, and medicinal chemists and biochemists; pharmacists; and upper-level undergraduate and graduate students in these disciplines.

Process Chemistry in the Pharmaceutical Industry

Process Chemistry in the Pharmaceutical Industry PDF Author: Kumar Gadamasetti
Publisher: CRC Press
ISBN: 9780824719814
Category : Medical
Languages : en
Pages : 514

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Book Description
Providing guidance for chemists and other scientists entering pharmaceutical discovery and development, this up-to-the-minute reference presents contributions from an international group of nearly 50 renowned researchers—offering a solid grounding in synthetic and physical organic chemistry, and clarifying the roles of various specialties in the development of new drugs. Featuring over 1000 references, tables, and illustrations, Process Chemistry in the Pharmaceutical Industry is sure to find its way to the bookshelves of organic, physical, analytical, process, and medicinal chemists and biochemists; pharmacists; and upper-level undergraduate and graduate students in these disciplines.

Process Chemistry in the Pharmaceutical Industry, Volume 2

Process Chemistry in the Pharmaceutical Industry, Volume 2 PDF Author: Kumar Gadamasetti
Publisher: CRC Press
ISBN: 9781420008357
Category : Science
Languages : en
Pages : 520

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Book Description
As pharmaceutical companies strive to develop safer medicines at a lower cost, they must keep pace with the rapid growth of technology and research methodologies. Defying the misconception of process chemistry as mere scale-up work, Process Chemistry in the Pharmaceutical Industry, Vol. 2: Challenges in an Ever Changing Climate explores novel applications of synthetic, physical, and analytical chemistry in drug discovery and development. It offers an accurate depiction of the most up-to-date process research and development methods applied to synthesis, clinical trials, and commercializing drug candidates. The second installment in this progressive series, this volumereviews the latest breakthroughs to advance process chemistry, including asymmetric synthesis, crystallization, morphology, enzymatic intervention, green chemistry, macromolecules (monoclonal antibodies, biological molecules, polymers), enantioselectivity, organometallic chemistry, process analytical tools, chemical engineering controls, regulatory compliance, and outsourcing/globalization. It explores new approaches to synthetic processes, examines the latest safety methods and experiment design, and suggests realistic solutions to problems encountered in manufacturing and process development. Significant topics include atom economy, ease of synthesis, instrumentation, automization, quality control, cost considerations, green practices, and future trends. Jointly edited by the founder/president of Delphian Pharmaceuticals and the director of Chemical R&D at Pfizer, this book brings together contributions byreputed scientists, technologists, engineers, and professors from leading academic institutions, such as the Imperial College, UK, the University of Tokyo, ETH, Switzerland, the International University at Bermen, Germany, and the University of Connecticut, USA, and from principal pharmaceutical companies that include Merck, Bristol Myers Squibb, Pfizer, Novartis, Eli Lilly, Astrazeneca and DSM.

Pharmaceutical Process Development

Pharmaceutical Process Development PDF Author: A. John Blacker
Publisher: Royal Society of Chemistry
ISBN: 1849731462
Category : Science
Languages : en
Pages : 401

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Book Description
This book is aimed at both graduates and postgraduates interested in a career in the pharmaceutical industry by informing them about the breadth of the work carried out in chemical research and development departments. It is also of great value to academics wishing to advise students on the merits of careers in chemical development over 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: Wiley-AIChE
ISBN: 9780470171561
Category : Medical
Languages : en
Pages : 416

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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.

Transition Metal-Catalyzed Couplings in Process Chemistry

Transition Metal-Catalyzed Couplings in Process Chemistry PDF Author: Javier Magano
Publisher: John Wiley & Sons
ISBN: 3527658920
Category : Science
Languages : en
Pages : 401

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Book Description
Transition metal-catalyzed coupling reactions have a rich history that led to the awarding of the 2010 Nobel Prize in Chemistry to Professors Suzuki, Heck, and Negishi for their pioneering contributions to the field. The coming of age of this active area of research is showcased in this book through case studies in which process chemists from the pharmaceutical industry share their personal experiences developing their own transition metal-catalyzed couplings for the large-scale manufacture of active pharmaceutical ingredients. Authors from Pfizer, Merck, Boehringer-Ingelheim, Novartis, Amgen, GSK, AstraZeneca, and other companies describe the evolution of robust coupling processes from inception through early and late development, including commercial routes where applicable. This book covers a wide range of coupling transformations while capturing the lessons learned from each process. Every case study details the optimization of at least one transition metal-catalyzed coupling while elaborating on issues such as design of experiments, scalability and throughput, product purification, process safety, and waste management. The important issue of metal removal and the different technologies available to accomplish this goal are also addressed. Finally, a section covers novel technologies for cross-coupling with high potential for future applications on a large scale, such as microwave and flow chemistry as well as green cross-couplings performed in water. With Forewords by Stephen L. Buchwald, Massachusetts Institute of Technology, Trevor Laird, Editor of Organic Process Research and Development and Neal G. Anderson, Anderson's Process Solutions LLC.

Chemical Engineering in the Pharmaceutical Industry

Chemical Engineering in the Pharmaceutical Industry PDF Author: David J. am Ende
Publisher: John Wiley & Sons
ISBN: 1119285860
Category : Technology & Engineering
Languages : en
Pages : 1168

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Book Description
A guide to the development and manufacturing of pharmaceutical products written for professionals in the industry, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry 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 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The 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: Contains 30new chapters or revised chapters specific to API, covering topics including: manufacturing quality by design, computational approaches, continuous manufacturing, crystallization and final form, process safety Expanded topics of scale-up, continuous processing, applications of thermodynamics and thermodynamic modeling, filtration and drying Presents updated and expanded example calculations Includes contributions from noted experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduate students, and professionals in the field of pharmaceutical sciences and manufacturing, the second edition of Chemical Engineering in the Pharmaceutical Industryf ocuses on the development and chemical engineering as well as operations specific to the design, formulation, and manufacture of drug substance and products.

The Art of Process Chemistry

The Art of Process Chemistry PDF Author: Nobuyoshi Yasuda
Publisher: John Wiley & Sons
ISBN: 9783527633586
Category : Science
Languages : en
Pages : 0

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Book Description
Providing must-have knowledge for the pharmaceutical industry and process chemists in industry, this ready reference offers solutions for saving time and money and supplying -- in a sustainable way -- valuable products. Application-oriented and well structured, each chapter presents successful strategies for the latest modern drugs, showing how to provide very fast bulk quantities of drug candidates. Throughout, the text illustrates how all the key factors are interwoven and dependent on one another in creating optimized methods for optimal products.

Chemical Engineering in the Pharmaceutical Industry

Chemical Engineering in the Pharmaceutical Industry PDF Author: Mary T. am Ende
Publisher: John Wiley & Sons
ISBN: 111928550X
Category : Technology & Engineering
Languages : en
Pages : 688

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Book Description
A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.

Pharmaceutical Process Chemistry for Synthesis

Pharmaceutical Process Chemistry for Synthesis PDF Author: Peter J. Harrington
Publisher: Wiley
ISBN: 9780470577554
Category : Science
Languages : en
Pages : 376

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Book Description
There is a need to explain that generic versions of a drug may not be manufactured by the same process as brand-name drugs and that the different processes may have dramatically different environmental impacts. Two global forces are at odds today—the push for "greener" processes and the push for lower drug prices. This book brings this conflict into sharp focus by discussing in detail the published process chemistry for top-selling small molecule drugs. Providing insights about process route selection, choice of reagents, and reaction conditions, Pharmaceutical Process Chemistry for Synthesis guides process chemists in identifying best processes for manufacturing these blockbuster drugs as they lose patent protection. Further, it highlights the strategies and methodology that might be useful for expediting the process research and development of the blockbusters of the future. Written from a refreshingly objective perspective, this book is essential for process chemists who need to devise practical syntheses for increasingly complex drugs in a constantly decreasing time frame.

Practical Application of Supercritical Fluid Chromatography for Pharmaceutical Research and Development

Practical Application of Supercritical Fluid Chromatography for Pharmaceutical Research and Development PDF Author:
Publisher: Elsevier
ISBN: 0323884881
Category : Science
Languages : en
Pages : 434

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Book Description
Practical Application of Supercritical Fluid Chromatography for Pharmaceutical Research and Development provides a valuable “go-to reference for many difficult-to-solve challenges using pertinent chromatographic theory, first-hand case studies, and examples provided from academic and industry experts. This text also enables professors teaching an analytical instrumental course to introduce and instruct students about one of the most sustainable and powerful separation methods currently available. While the text has broad applicability across industrial sectors, it focuses primarily on application in the pharmaceutical industry. The book is designed to allow readers to align current HPLC/UHPLC capabilities with SFC as an orthogonal tool for project specific methods in the pharmaceutical industry. It highlights where SFC falls on the spectrum of useful chromatographic tools for routine and challenging separative methods. Experienced HPLC users who are interested in developing knowledge in orthogonal separation techniques, as well as newcomers to the field of separation science, will find this text particularly useful. Chapters address where SFC may fit the analytical needs of the pharmaceutical industry and alert the readers as to where the technique will not fit. Readers will gain an understanding of how and where SFC may be applied and adapted more routinely across the pharmaceutical industry as a ‘green’ way of undertaking separation opportunities and challenges. Areas within the pharmaceutical industry include early drug discovery, process chemistry, and late stage development and manufacturing. Describes approaches to SFC column and mobile phase selection for method development for both analytical and preparative tasks Gives practical examples of how analytical SFC enables the monitoring of synthetic reactions including unstable intermediates, chiral and achiral polar reactants and products across small and large modalities Provides need-focused case studies for pharmaceutical analysts, process chemists, and contract chemistry facilities that can benefit from monitoring or purifying polar intermediates, mutagenic impurities, nitrosamines and other reaction by-products including excipients and metabolites