Process Chemistry in the Pharmaceutical Industry

Author: Kumar Gadamasetti

Publisher: CRC Press

ISBN: 9780824719814

Category: Medical

Page: 500

View: 1154

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

Challenges in an Ever Changing Climate

Author: Kumar Gadamasetti,Tamim Braish

Publisher: CRC Press

ISBN: 9781420008357

Category: Science

Page: 520

View: 8954

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 Chemistry

Author: Takayuki Shioiri,Kunisuke Izawa,Toshiro Konoike

Publisher: John Wiley & Sons

ISBN: 3527633693

Category: Technology & Engineering

Page: 526

View: 4595

Covering the whole area of process chemistry in the pharmaceutical industry, this monograph provides the essential knowledge on the basic chemistry needed for future development and key industrial techniques, as well as morphology, engineering and regulatory compliances. Application-oriented and well structured, the authors include recent examples of excellent industrial production of active pharmaceutical ingredients.

The Management of Chemical Process Development in the Pharmaceutical Industry

Author: Derek Walker

Publisher: John Wiley & Sons

ISBN: 0470259507

Category: Medical

Page: 370

View: 1905

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.

Chemical Engineering in the Pharmaceutical Industry

R&D to Manufacturing

Author: David J. am Ende

Publisher: John Wiley & Sons

ISBN: 1118088107

Category: Technology & Engineering

Page: 904

View: 3598

This book deals with various unique elements in the drug development process within chemical engineering science and pharmaceutical R&D. The book is intended to be used as a professional reference and potentially as a text book reference in pharmaceutical engineering and pharmaceutical sciences. Many of the experimental methods related to pharmaceutical process development are learned on the job. This book is intended to provide many of those important concepts that R&D Engineers and manufacturing Engineers should know and be familiar if they are going to be successful in the Pharmaceutical Industry. These include basic analytics for quantitation of reaction components– often skipped in ChE Reaction Engineering and kinetics books. In addition Chemical Engineering in the Pharmaceutical Industry introduces contemporary methods of data analysis for kinetic modeling and extends these concepts into Quality by Design strategies for regulatory filings. For the current professionals, in-silico process modeling tools that streamline experimental screening approaches is also new and presented here. Continuous flow processing, although mainstream for ChE, is unique in this context given the range of scales and the complex economics associated with transforming existing batch-plant capacity. The book will be split into four distinct yet related parts. These parts will address the fundamentals of analytical techniques for engineers, thermodynamic modeling, and finally provides an appendix with common engineering tools and examples of their applications.

Green Chemistry in the Pharmaceutical Industry

Author: Peter J. Dunn,Andrew Wells,Michael T. Williams

Publisher: John Wiley & Sons

ISBN: 9783527629695

Category: Science

Page: 368

View: 3083

Edited by three of the world's leading pharmaceutical scientists, this is the first book on this important and hot topic, containing much previously unpublished information. As such, it covers all aspects of green chemistry in the pharmaceutical industry, from simple molecules to complex proteins, and from drug discovery to the fate of pharmaceuticals in the environment. Furthermore, this ready reference contains several convincing case studies from industry, such as Taxol, Pregabalin and Crestor, illustrating how this multidisciplinary approach has yielded efficient and environmentally-friendly processes. Finally, a section on technology and tools highlights the advantages of green chemistry.

Principles of Process Research and Chemical Development in the Pharmaceutical Industry

Author: Oljan Repic

Publisher: Wiley-Interscience

ISBN: 9780471165163

Category: Science

Page: 240

View: 8351

This text discusses the functions of Process R&D (research and development), which involves the method of transforming a research synthetic procedure into a plant process and the key aspects of a synthesis that must be considered when scaling up a process. Topics consist of: basic principles of chemical development; techniques for the minimization of by-product impurities; criteria for cost-effective synthesis of enantiopure compounds by resolutions; asymmetric synthesis, and "chiral pool" strategy; synthesis for labeling substances with hydrogen or carbon isotopes; and last, licensing.

The Art of Process Chemistry

Author: Nobuyoshi Yasuda

Publisher: John Wiley & Sons

ISBN: 3527633588

Category: Science

Page: 298

View: 4018

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.

Pharmaceutical Process Development

Current Chemical and Engineering Challenges

Author: A. John Blacker,Mike T. Williams

Publisher: Royal Society of Chemistry

ISBN: 1849731462

Category: Science

Page: 354

View: 2044

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.

Pharmaceutical Process Chemistry for Synthesis

Rethinking the Routes to Scale-Up

Author: Peter J. Harrington

Publisher: John Wiley & Sons

ISBN: 9780470922866

Category: Science

Page: 448

View: 8137

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.

Transition Metal-Catalyzed Couplings in Process Chemistry

Case Studies From the Pharmaceutical Industry

Author: Javier Magano,Joshua R. Dunetz

Publisher: John Wiley & Sons

ISBN: 3527658920

Category: Science

Page: 401

View: 6930

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.

Scalable Green Chemistry

Case Studies from the Pharmaceutical Industry

Author: Stefan Koenig

Publisher: CRC Press

ISBN: 9814364819

Category: Medical

Page: 350

View: 9899

Packed with real-world examples, this book illustrates the 12 principles of green chemistry. These diverse case studies demonstrate to scientists and students that beyond the theory, the challenges of green chemistry in pharmaceutical discovery and development remain an ongoing endeavor. By informing and welcoming additional practitioners to this mission, the negative environmental impact of pharmaceutical products will continue to be minimized. Green chemistry is the methodology by which chemical production in this industry can become more efficient, adding environmental stewardship to the noble mission of treating human disease.

Organometallics in Process Chemistry

Author: Rob Larsen,Ahmed F. Abdel-Magid

Publisher: Springer Science & Business Media

ISBN: 9783540016038

Category: Science

Page: 295

View: 6861

The design of efficient syntheses of medicinal agents is one of the prime goals of the process chemist in the pharmaceutical industry. The expanding list of metal-mediated reactions has had a major impact on this endeavor over the last two decades. This volume will highlight some of the areas of organometallic chemistry that have played a particularly important role in development. The chapters are written by chemists who work in the process groups of major pharmaceutical companies and fine chemical manufacturers. Having demonstrated the power of organometallics in their processes the authors herein expand upon their experiences with examples from the literature as reported by process groups within the industry. The chapters are organized either by the application of a particular metal or reaction class. Removal of the residual metal(s) from the isolated active pharmaceutical ingredient (API) is key to the release of the material for human consumption, and hence, is reviewed here as well. This volume of Topics in Organometallic Chemistry is presented to offer a representative cross section of organometallic applications in the pharmaceutical industry as well as to give an appreciation for the creativity possible in process chemistry.

Practical Process Research and Development

Author: Neal G. Anderson

Publisher: Elsevier

ISBN: 0080514480

Category: Science

Page: 354

View: 9192

This book provides a comprehensive, step-by-step approach to organic process research and development in the pharmaceutical, fine chemical, and agricultural chemical industries. Process R&D describes the steps taken, following synthesis and evaluation, to bring key compounds to market in a cost-effective manner. More people are being hired for work in this area as increasing numbers of drug candidates are identified through combinatorial chemistry and high-throughput screening. The book is directed to industrial (primarily organic) chemists, and academicians (particularly those involved in a growing number of start-up companies) and students who need insight into industrial process R&D. Current books do not describe 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." "Practical Process Research and Development" will be a valuable resource for researchers, managers, and graduate students. 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 Includes over 100 tips for rapid process development Presents guidelines for implementing and troubleshooting processes

The Chemistry of Process Development in Fine Chemical and Pharmaceutical Industry

Author: Someswara Rao

Publisher: Wiley

ISBN: 9780470319956

Category: Technology & Engineering

Page: 1328

View: 2850

This book brings together the chemical strategies used in the optimisation of organic reactions and processes, and highlights the practical and technological options available. This book offers: an encyclopedic treatment of organic chemistry from an industrial, process research and development, and manufacturing point of view plenty of examples to illustrate the scope and limitation of the strategies a comprehensive index organised by topic, reaction type, and reagent an extensive literature survey. This is an essential and comprehensive guide for experienced practitioners of chemical process research and development, fresh recruits to chemical industry R&D divisions, and academics who are interested in interacting with the chemical industry, optimising their synthetic strategies, and enriching the field of atom economy.

Process Analytical Technology

Spectroscopic Tools and Implementation Strategies for the Chemical and Pharmaceutical Industries

Author: Katherine A. Bakeev

Publisher: John Wiley & Sons

ISBN: 0470689609

Category: Science

Page: 576

View: 9076

Process Analytical Technology explores the concepts of PAT and its application in the chemical and pharmaceutical industry from the point of view of the analytical chemist. In this new edition all of the original chapters have been updated and revised, and new chapters covering the important topics of sampling, NMR, fluorescence, and acoustic chemometrics have been added. Coverage includes: Implementation of Process Analytical Technologies UV-Visible Spectroscopy for On-line Analysis Infrared Spectroscopy for Process Analytical Applications Process Raman Spectroscopy Process NMR Spectrscopy: Technology and On-line Applications Fluorescent Sensing and Process Analytical Applications Chemometrics in Process Analytical Technology (PAT) On-Line PAT Applications of Spectroscopy in the Pharmaceutical Industry Future Trends for PAT for Increased Process Understanding and Growing Applications in Biomanufacturing NIR Chemical Imaging This volume is an important starting point for anyone wanting to implement PAT and is intended not only to assist a newcomer to the field but also to provide up-to-date information for those who practice process analytical chemistry and PAT. It is relevant for chemists, chemical and process engineers, and analytical chemists working on process development, scale-up and production in the pharmaceutical, fine and specialty chemicals industries, as well as for academic chemistry, chemical engineering, chemometrics and pharmaceutical science research groups focussing on PAT. Review from the First Edition “The book provides an excellent first port of call for anyone seeking material and discussions to understand the area better. It deserves to be found in every library that serves those who are active in the field of Process Analytical Technology.”—Current Engineering Practice

Green Techniques for Organic Synthesis and Medicinal Chemistry

Author: Wei Zhang,Berkeley Cue

Publisher: John Wiley & Sons

ISBN: 0470711515

Category: Medical

Page: 742

View: 6329

Green chemistry is a new way of looking at organic synthesis and the design of drug molecules, offering important environmental and economic advantages over traditional synthetic processes. Pharmaceutical companies are increasingly turning to the principles of green chemistry in an effort to reduce waste, reduce costs and develop environmentally benign processes. Green Techniques for Organic Synthesis and Medicinal Chemistry presents an overview of the established and emerging techniques in green organic chemistry, highlighting their applications in medicinal chemistry. The book is divided into four parts: Introduction: Introduces the reader to the toxicology of organic chemicals,their environmental impact, and the concept of green chemistry. Green Catalysis: Covers a variety of green catalytic techniques including organocatalysis, supported catalysis, biocatalysis, fluorous catalysis, and catalytic direct C-H bond activation reactions. Green Synthetic Techniques: Presents a series of new techniques, assessing the green chemistry aspects and limitations (i.e. cost, equipment, expertise). Techniques include reactions in alternative solvents, atom economic multicomponent reactions, microwave and ultrasonic reactions, solid-supported synthesis, fluorous and ionic liquid-based recycling techniques, and flow reactors. Green Techniques in Pharmaceutical Industry: Covers applications of green chemistry concepts and special techniques for medicinal chemistry, including synthesis, analysis, separation, formulation, , and drug delivery. Process and business case studies are included to illustrate the applications in the pharmaceutical industry. Green Techniques for Organic Synthesis and Medicinal Chemistry is an essential resource on green chemistry technologies for academic researchers, R&D professionals and students working in organic chemistry and medicinal chemistry.

Multivariate Analysis in the Pharmaceutical Industry

Author: Ana Patricia Ferreira,Jose C. Menezes,Mike Tobyn

Publisher: Academic Press

ISBN: 012811066X

Category: Medical

Page: 464

View: 6541

Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each step. It includes an overview of regulatory guidance specific to the use of these methods, along with perspectives on the applications of these methods that allow for testing, monitoring and controlling products and processes. The book seeks to put multivariate analysis into a pharmaceutical context for the benefit of pharmaceutical practitioners, potential practitioners, managers and regulators. Users will find a resources that addresses an unmet need on how pharmaceutical industry professionals can extract value from data that is routinely collected on products and processes, especially as these techniques become more widely used, and ultimately, expected by regulators. Targets pharmaceutical industry practitioners and regulatory staff by addressing industry specific challenges Includes case studies from different pharmaceutical companies and across product lifecycle of to introduce readers to the breadth of applications Contains information on the current regulatory framework which will shape how multivariate analysis (MVA) is used in years to come

Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry

Author: Richard K. Burdick,David J. LeBlond,Lori B. Pfahler,Jorge Quiroz,Leslie Sidor,Kimberly Vukovinsky,Lanju Zhang

Publisher: Springer

ISBN: 3319501860

Category: Medical

Page: 379

View: 8372

This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry. Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples.

Heat Transfer in the Chemical, Food and Pharmaceutical Industries

Author: Jean-Paul Duroudier

Publisher: Elsevier

ISBN: 0081017804

Category: Technology & Engineering

Page: 414

View: 6612

Heat Transfer in the Chemical, Food and Pharmaceutical Industries, a new volume in the Industrial Equipment for Chemical Engineering set, includes thirteen independent volumes on how to perform the selection and calculation of equipment involved in the thirteen basic operations of process engineering, offering readers reliable and simple, easy to follow methods. Throughout these concise and easy-to-use books, the author uses his vast practical experience and precise knowledge of global research to present an in-depth study of a variety of aspects within the field of chemical engineering. In this volume, the author focuses the heat exchanges between gases, liquids, divided solids and compact solids without changes of phase. This book includes discussion on changes of phase, heat exchange processes, combustion and the necessary equipment to measure these. The chapters are complemented with appendices which provide additional information as well as any associated references.