Process Chemistry in the Pharmaceutical Industry

Author: Kumar Gadamasetti

Publisher: CRC Press

ISBN: 9780824719814

Category: Medical

Page: 500

View: 3084

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: 1713

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.

The Art of Process Chemistry

Author: Nobuyoshi Yasuda

Publisher: John Wiley & Sons

ISBN: 3527633588

Category: Science

Page: 298

View: 8172

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 Chemistry

Author: Takayuki Shioiri,Kunisuke Izawa,Toshiro Konoike

Publisher: John Wiley & Sons

ISBN: 3527633693

Category: Technology & Engineering

Page: 526

View: 1729

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.

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: 5079

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.

The Management of Chemical Process Development in the Pharmaceutical Industry

Author: Derek Walker

Publisher: John Wiley & Sons

ISBN: 0470259507

Category: Medical

Page: 370

View: 7756

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.

Organometallics in Process Chemistry

Author: Rob Larsen,Ahmed F. Abdel-Magid

Publisher: Springer Science & Business Media

ISBN: 9783540016038

Category: Science

Page: 295

View: 6120

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.

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: 8711

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.

Handbook for Chemical Process Research and Development

Author: Wenyi Zhao

Publisher: CRC Press

ISBN: 1315350203

Category: Medical

Page: 858

View: 3545

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.

Principles of Process Research and Chemical Development in the Pharmaceutical Industry

Author: Oljan Repic

Publisher: Wiley-Interscience

ISBN: 9780471165163

Category: Science

Page: 240

View: 1828

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.

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: 3938

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.

Heterocyclic Chemistry in Drug Discovery

Author: Jie Jack Li

Publisher: John Wiley & Sons

ISBN: 1118354435

Category: Science

Page: 720

View: 8196

Enables researchers to fully realize the potential to discover new pharmaceuticals among heterocyclic compounds Integrating heterocyclic chemistry and drug discovery, this innovative text enables readers to understand how and why these two fields go hand in hand in the effective practice of medicinal chemistry. Contributions from international leaders in the field review more than 100 years of findings, explaining their relevance to contemporary drug discovery practice. Moreover, these authors have provided plenty of practical guidance and tips based on their own academic and industrial laboratory experience, helping readers avoid common pitfalls. Heterocyclic Chemistry in Drug Discovery is ideal for readers who want to fully realize the almost limitless potential to discover new and effective pharmaceuticals among heterocyclic compounds, the largest and most varied family of organic compounds. The book features: Several case studies illustrating the role and application of 3, 4, 5, and 6+ heterocyclic ring systems in drug discovery Step-by-step descriptions of synthetic methods and practical techniques Examination of the physical properties for each heterocycle, including NMR data and quantum calculations Detailed explanations of the complexity and intricacies of reactivity and stability for each class of heterocycles Heterocyclic Chemistry in Drug Discovery is recommended as a textbook for organic and medicinal chemistry courses, particularly those emphasizing heterocyclic chemistry. The text also serves as a guide for medicinal and process chemists in the pharmaceutical industry, offering them new insights and new paths to explore for effective drug discovery.

Practical Process Research and Development

Author: Neal G. Anderson

Publisher: Elsevier

ISBN: 0080514480

Category: Science

Page: 354

View: 6339

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

Scalable Green Chemistry

Case Studies from the Pharmaceutical Industry

Author: Stefan Koenig

Publisher: CRC Press

ISBN: 9814364819

Category: Medical

Page: 350

View: 6581

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.

Practical Process Research and Development

A Guide for Organic Chemists

Author: Neal G. Anderson

Publisher: Academic Press

ISBN: 0123865379

Category: Science

Page: 475

View: 2340

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

High-Throughput Analysis in the Pharmaceutical Industry

Author: Perry G. Wang

Publisher: CRC Press

ISBN: 9781420059540

Category: Medical

Page: 432

View: 3498

The introduction of combinatorial chemistry technology has increased the amount of compounds generated in a year from 50 to 2000. Conventional analytical approaches simply cannot keep up. These circumstances have caused drug discovery to take on the shape of a bottleneck, like traffic through a toll booth. In order to break the bottleneck, a corresponding revolutionary improvement to the conventional methodology must happen.

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: 9413

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.

Naturstoffe der chemischen Industrie

Author: Bernd Schäfer

Publisher: Spektrum Akademischer Verlag

ISBN: 9783827416148

Category: Science

Page: 544

View: 4130

Dieses Buch geht auf eine Vorlesung an der Universität Heidelberg zurück und richtet sich in erster Linie an Studenten, aber auch an Hochschuldozenten, Chemielehrer und Industriechemiker. Es vermittelt Einblicke in die moderne Naturstoffchemie und die Entwicklung komplexer Moleküle (asymmetrische und heterozyklische Verbindungen, polyzyklische Strukturen, makrozyklische und kleine Ringe) in der chemischen Industrie. Ein wichtiges Anliegen des Autors besteht darin, exemplarisch zu belegen, welche Aspekte eine Rolle spielen, wenn man im technischen Maßstab komplexe Verbindungen "auf elegantem Weg" herstellen will. So lernt der Leser die Grundlagen, die für einen jungen Chemiker in der chemischen Industrie unentbehrlich sind. Das Buch deckt ein breites Spektrum von Naturstoffen oder davon abgeleiteten Substanzen ab, darunter Farbstoffe wie etwa Indigo, in der Nahrungsmittelindustrie verwendete Verbindungen wie Coffein, Vanillin, Carotenoide und Aminosäuren, Arzneimittel wie Antibiotika, Opioide, Lipstatin und Steroide, Agrochemikalien wie Herbizide, Fungizide und Insektizide oder auch Duftstoffe wie Moschus und Damascon. Jedes Kapitel liefert auch historische und soziale Hintergrundinformationen zu dem jeweiligen Naturstoff und beschreibt seine biologische Aktivität, seine Entdeckung und seine wichtigsten Modifikationen durch die industrielle Chemie. In vielen Fällen wird die industrielle Synthese mit der Biosynthese verglichen. Überdies beleuchtet das Buch moderne Aspekte und zukünftige Entwicklungen in der Naturstoffsynthese. Ohne auf jeden industriell hergestellten Naturstoff einzugehen - was angesichts der Fülle der Substanzen in einem Lehrbuch auch gar nicht möglich ist -, bietet das verständlich geschriebene Werk einen guten Überblick über das gesamte Gebiet. Dabei kommt die "grüne Chemie" ebenso zur Sprache wie die Atomökonomie und "Eleganz" in der industriellen Naturstoffsynthese.

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: 9785

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

Pharmaceutical Analysis for Small Molecules

Author: Behnam Davani

Publisher: John Wiley & Sons

ISBN: 1119121116

Category: Medical

Page: 256

View: 9656

A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry. This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book. Topics covered include: Drug Approval Process and Regulatory Requirements (private standards) Pharmacopeias and Compendial Approval Process (public standards) Common methods in pharmaceutical analysis (typically compendial) Common Calculations for assays and impurities and other specific tests Analytical Method Validation, Verification, Transfer Specifications including how to handle out of specification (OOS) and out of trend (OOT) Impurities including organic, inorganic, residual solvents and elemental impurities Good Documentation Practices for regulatory environment Management of Analytical Laboratories Analytical Instrument Qualifications including IQ, OQ, PQ and VQ Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted. Pharmaceutical Analysis for Small Molecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.