Comprehensive Quality By Design For Pharmaceutical Product Development And Manufacture

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Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Author : Gintaras V. Reklaitis
Publisher : John Wiley & Sons
ISBN 13 : 0470942371
Total Pages : 418 pages
Book Rating : 4.4/5 (79 download)

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Book Synopsis Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture by : Gintaras V. Reklaitis

Download or read book Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture written by Gintaras V. Reklaitis and published by John Wiley & Sons. This book was released on 2017-10-09 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectors—drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processes The role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process.

Pharmaceutical Quality by Design

Author : Walkiria S. Schlindwein
Publisher : John Wiley & Sons
ISBN 13 : 1118895215
Total Pages : 368 pages
Book Rating : 4.1/5 (188 download)

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Book Synopsis Pharmaceutical Quality by Design by : Walkiria S. Schlindwein

Download or read book Pharmaceutical Quality by Design written by Walkiria S. Schlindwein and published by John Wiley & Sons. This book was released on 2018-01-05 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.

Pharmaceutical Quality by Design

Author : Walkiria S. Schlindwein
Publisher : John Wiley & Sons
ISBN 13 : 1118895207
Total Pages : 375 pages
Book Rating : 4.1/5 (188 download)

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Book Synopsis Pharmaceutical Quality by Design by : Walkiria S. Schlindwein

Download or read book Pharmaceutical Quality by Design written by Walkiria S. Schlindwein and published by John Wiley & Sons. This book was released on 2018-03-19 with total page 375 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.

Quality by Design for Biopharmaceutical Drug Product Development

Author : Feroz Jameel
Publisher : Springer
ISBN 13 : 1493923161
Total Pages : 710 pages
Book Rating : 4.4/5 (939 download)

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Book Synopsis Quality by Design for Biopharmaceutical Drug Product Development by : Feroz Jameel

Download or read book Quality by Design for Biopharmaceutical Drug Product Development written by Feroz Jameel and published by Springer. This book was released on 2015-04-01 with total page 710 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.

Pharmaceutical Quality by Design

Author : Sarwar Beg
Publisher : Academic Press
ISBN 13 : 0128163720
Total Pages : 448 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Pharmaceutical Quality by Design by : Sarwar Beg

Download or read book Pharmaceutical Quality by Design written by Sarwar Beg and published by Academic Press. This book was released on 2019-03-27 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies

Pharmaceutical Product Development

Author : Vandana B. Patravale
Publisher : CRC Press
ISBN 13 : 1498730787
Total Pages : 433 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Pharmaceutical Product Development by : Vandana B. Patravale

Download or read book Pharmaceutical Product Development written by Vandana B. Patravale and published by CRC Press. This book was released on 2016-05-25 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof. Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms. The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.

Handbook of Analytical Quality by Design

Author : Sarwar Beg
Publisher : Academic Press
ISBN 13 : 0128203331
Total Pages : 225 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Handbook of Analytical Quality by Design by : Sarwar Beg

Download or read book Handbook of Analytical Quality by Design written by Sarwar Beg and published by Academic Press. This book was released on 2021-01-09 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. Concise language for easy understanding of the novel and holistic concept Covers key aspects of analytical development and validation Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance

Pharmaceutical Quality by Design Using JMP

Author : Rob Lievense
Publisher :
ISBN 13 : 9781629608648
Total Pages : 436 pages
Book Rating : 4.6/5 (86 download)

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Book Synopsis Pharmaceutical Quality by Design Using JMP by : Rob Lievense

Download or read book Pharmaceutical Quality by Design Using JMP written by Rob Lievense and published by . This book was released on 2018-10 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Solve your pharmaceutical product development and manufacturing problems using JMP®. Pharmaceutical Quality by Design Using JMP®: Solving Product Development and Manufacturing Problems provides broad-based techniques available in JMP to visualize data and run statistical analyses for areas common in healthcare product manufacturing. As international regulatory agencies push the concept of Quality by Design (QbD), there is a growing emphasis to optimize the processing of products. This book uses practical examples from the pharmaceutical and medical device industries to illustrate easy-to-understand ways of incorporating QbD elements using JMP. Pharmaceutical Quality by Design Using JMP® opens by demonstrating the easy navigation of JMP to visualize data through the distribution function and the graph builder and then highlights the following: the powerful dynamic nature of data visualization that enables users to be able to quickly extract meaningful information tools and techniques designed for the use of structured, multivariate sets of experiments examples of complex analysis unique to healthcare products such as particle size distributions/drug dissolution, stability of drug products over time, and blend uniformity/content uniformity. Scientists, engineers, and technicians involved throughout the pharmaceutical and medical device product life cycles will find this book invaluable. This book is part of the SAS Press program.

Quality by Design for Biopharmaceuticals

Author : Anurag S. Rathore
Publisher : John Wiley & Sons
ISBN 13 : 1118210913
Total Pages : 279 pages
Book Rating : 4.1/5 (182 download)

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Book Synopsis Quality by Design for Biopharmaceuticals by : Anurag S. Rathore

Download or read book Quality by Design for Biopharmaceuticals written by Anurag S. Rathore and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA) Development of the design space for a manufacturing process How to employ QbD to design a formulation process Raw material analysis and control strategy for QbD Process Analytical Technology (PAT) and how it relates to QbD Relevant PAT tools and applications for the pharmaceutical industry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.

Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development

Author : Márcia Cristina Breitkreitz
Publisher : Springer Nature
ISBN 13 : 3031315057
Total Pages : 268 pages
Book Rating : 4.0/5 (313 download)

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Book Synopsis Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development by : Márcia Cristina Breitkreitz

Download or read book Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development written by Márcia Cristina Breitkreitz and published by Springer Nature. This book was released on 2023-07-13 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by twenty-five authors from academia, pharmaceutical industry and Pharmacopeias worldwide, this monograph covers the fundamentals and applications of Quality by Design (QbD) and Analytical Quality by Design (AQbD) in a practical and didactic manner. The book starts by describing the motivation and the urgent need for the implementation of the QbD framework in pharmaceutical development, along with the definition of its major elements: Quality Target Product Profile (QTTP), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Critical Material Attributes (CMAs) and the importance of using multivariate methods of Design of Experiments (DOE). The concept of life cycle and regulatory perspectives are discussed. Three chapters are entirely dedicated to DOE theory from screening to optimization designs. Moreover, a comprehensive discussion on modelling and data treatment is presented. Practical aspects of QbD and DOE for pharmaceutical product and process of different dosage forms is included, as well as a practical guide of the input process variables, material attributes, intermediate, and final quality attributes for the most representative pharmaceutical processes. Analytical Quality by Design (AQbD) is also deeply explored, including risk analysis, definitions of Analytical Target Profile (ATP), Method Operable Design Region (MODR) and the life cycle approach, taking into account the compendial and regulatory perspectives. A detailed example of a new chromatographic method for the quality control of a pharmaceutical topical product based on the AQbD procedure is shown. Finally, advanced statistical approaches and DOE methods for extraction studies of bioactive compounds are also presented. The vast amount of information offered in this book provides a comprehensive perspective on QbD, AQbD and DOE principles, essential tools for modern pharmaceutical and analytical development.

Design of Experiments for Pharmaceutical Product Development

Author : Sarwar Beg
Publisher : Springer Nature
ISBN 13 : 9813343516
Total Pages : 190 pages
Book Rating : 4.8/5 (133 download)

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Book Synopsis Design of Experiments for Pharmaceutical Product Development by : Sarwar Beg

Download or read book Design of Experiments for Pharmaceutical Product Development written by Sarwar Beg and published by Springer Nature. This book was released on 2021-01-22 with total page 190 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book volume provides complete and updated information on the applications of Design of Experiments (DoE) and related multivariate techniques at various stages of pharmaceutical product development. It discusses the applications of experimental designs that shall include oral, topical, transdermal, injectables preparations, and beyond for nanopharmaceutical product development, leading to dedicated case studies on various pharmaceutical experiments through illustrations, art-works, tables and figures. This book is a valuable guide for all academic and industrial researchers, pharmaceutical and biomedical scientists, undergraduate and postgraduate research scholars, pharmacists, biostatisticians, biotechnologists, formulations and process engineers, regulatory affairs and quality assurance personnel.

The Future of Pharmaceutical Product Development and Research

Author :
Publisher : Academic Press
ISBN 13 : 0128144556
Total Pages : 974 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis The Future of Pharmaceutical Product Development and Research by :

Download or read book The Future of Pharmaceutical Product Development and Research written by and published by Academic Press. This book was released on 2020-09-02 with total page 974 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals, and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines. Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries. Provides an overview of practical information for clinical trials Outlines how to ensure an environment that follows Good Manufacturing Practice (GMP) Examines recent developments and suggests future directions for drug production methods and techniques

Sterile Product Development

Author : Parag Kolhe
Publisher : Springer Science & Business Media
ISBN 13 : 1461479789
Total Pages : 585 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Sterile Product Development by : Parag Kolhe

Download or read book Sterile Product Development written by Parag Kolhe and published by Springer Science & Business Media. This book was released on 2013-10-12 with total page 585 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.

Continuous Manufacturing of Pharmaceuticals

Author : Peter Kleinebudde
Publisher : John Wiley & Sons
ISBN 13 : 1119001358
Total Pages : 632 pages
Book Rating : 4.1/5 (19 download)

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Book Synopsis Continuous Manufacturing of Pharmaceuticals by : Peter Kleinebudde

Download or read book Continuous Manufacturing of Pharmaceuticals written by Peter Kleinebudde and published by John Wiley & Sons. This book was released on 2017-07-14 with total page 632 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.

Biocatalysis for the Pharmaceutical Industry

Author : Junhua (Alex) Tao
Publisher : John Wiley & Sons
ISBN 13 : 0470823151
Total Pages : 250 pages
Book Rating : 4.4/5 (78 download)

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Book Synopsis Biocatalysis for the Pharmaceutical Industry by : Junhua (Alex) Tao

Download or read book Biocatalysis for the Pharmaceutical Industry written by Junhua (Alex) Tao and published by John Wiley & Sons. This book was released on 2009-07-23 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biocatalysis is rapidly evolving into a key technology for the discovery and production of chemicals, especially in the pharmaceutical industry, where high yielding chemo-, regio-, and enantioselective reactions are critical. Taking the latest breakthroughs in genomics and proteomics into consideration, Biocatalysis for the Pharmaceutical Industry concisely yet comprehensively discusses the modern application of biocatalysis to drug discovery, development, and manufacturing. Written by a team of leading experts, the book offers deep insight into this cutting edge field. Covers a wide range of topics in a systematic manner with an emphasis on industrial applications Provides a thorough introduction to the latest biocatalysts, modern expression hosts, state-of-the-art directed evolution, high throughput screening, and bioprocess engineering Addresses frontier subjects such as emerging enzymes, metabolite profiling, combinatorial biosynthesis, metabolic engineering, and autonomous enzymes for the synthesis and development of chiral molecules, drug metabolites, and semi-synthetic medicinal compounds and natural product analogs Highlights the impact of biocatalysis on green chemistry Contains numerous graphics to illustrate concepts and techniques Biocatalysis for the Pharmaceutical Industry is an essential resource for scientists, engineers, and R&D policy makers in the fine chemical, pharmaceutical, and biotech industries. It is also an invaluable tool for academic researchers and advanced students of organic and materials synthesis, chemical biology, and medicinal chemistry.

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

Author : Hamid Mollah
Publisher : John Wiley & Sons
ISBN 13 : 0470552344
Total Pages : 432 pages
Book Rating : 4.4/5 (75 download)

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Book Synopsis Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing by : Hamid Mollah

Download or read book Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing written by Hamid Mollah and published by John Wiley & Sons. This book was released on 2013-03-18 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applications Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.

Introduction to Quality by Design for Pharmaceuticals

Author : Nilesh Desai
Publisher : Pharmamed Press
ISBN 13 : 9789386819802
Total Pages : 192 pages
Book Rating : 4.8/5 (198 download)

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Book Synopsis Introduction to Quality by Design for Pharmaceuticals by : Nilesh Desai

Download or read book Introduction to Quality by Design for Pharmaceuticals written by Nilesh Desai and published by Pharmamed Press. This book was released on 2017-10-03 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality by design (QbD) is extensively used tool in formulation and development. QbD is a method of choice in product development for robust and quality product incorporating continuous improvement. The objective of the book is to study the implementation of QbD and wide-ranging QbD based product development template for different formulations and analytical procedures. The way QbD is implemented in Pharmaceutical Industry, Academicians/ Institutes are way behind in this competition. The reason being, concepts of QbD are poorly explored byPharma Researchers due to nonexistence of expertise and resources. Researchers tend to adapt moderately the principles of QbD due to inadequate understanding of QbD principles. The use of QbD in formulation development will be advantageous to young researchers and academics.