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Handbook of Process Chromatography

Handbook of Process Chromatography Author Gunter Jagschies
ISBN-10 0080554512
Release 2007-12-08
Pages 382
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This book will update the original edition published in 1997. Since the publication of the first edition, the biotechnology and biologics industries have gained extensive knowledge and experience in downstream processing using chromatography and other technologies associated with recovery and purification unit operations. This book will tie that experience together for the next generation of readers. Updates include: - sources and productivity - types of products made today - experiences in clinical and licensed products - economics - current status of validation - illustrations and tables - automated column packing - automated systems New topics include: - the use of disposables - multiproduct versus dedicated production - design principles for chromatography media and filters - ultrafiltration principles and optimization - risk assessments - characterization studies - design space - platform technologies - process analytical technologies (PATs) - biogenerics - comparability assessments Key Features: - new approaches to process optimiaztion - use of patform technologies - applying risk assessment to process design



Biopharmaceutical Processing

Biopharmaceutical Processing Author Gunter Jagschies
ISBN-10 9780128125526
Release 2018-01-18
Pages 1308
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Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. Offers a comprehensive, go-to reference for daily work decisions Covers both upstream and downstream processes Includes case studies that emphasize financial outcomes Presents summaries, decision grids, graphs and overviews for quick reference



Process Scale Purification of Antibodies

Process Scale Purification of Antibodies Author Uwe Gottschalk
ISBN-10 9781119126911
Release 2017-04-03
Pages 752
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Promoting a continued and much-needed renaissance in biopharmaceutical manufacturing, this book covers the different strategies and assembles top-tier technology experts to address the challenges of antibody purification. • Updates existing topics and adds new ones that include purification of antibodies produced in novel production systems, novel separation technologies, novel antibody formats and alternative scaffolds, and strategies for ton-scale manufacturing • Presents new and updated discussions of different purification technologies, focusing on how they can address the capacity crunch in antibody purification • Emphasizes antibodies and innovative chromatography methods for processing



Protein Therapeutics

Protein Therapeutics Author Zuben E. Sauna
ISBN-10 9783319418186
Release 2017-07-19
Pages 182
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Medicinal chemistry is both science and art. The science of medicinal chemistry offers mankind one of its best hopes for improving the quality of life. The art of medicinal chemistry continues to challenge its practitioners with the need for both intuition and experience to discover new drugs. Hence sharing the experience of drug research is uniquely beneficial to the field of medicinal chemistry. Drug research requires interdisciplinary team-work at the interface between chemistry, biology and medicine. Therefore, the topic-related series Topics in Medicinal Chemistry covers all relevant aspects of drug research, e.g. pathobiochemistry of diseases, identification and validation of (emerging) drug targets, structural biology, drugability of targets, drug design approaches, chemogenomics, synthetic chemistry including combinatorial methods, bioorganic chemistry, natural compounds, high-throughput screening, pharmacological in vitro and in vivo investigations, drug-receptor interactions on the molecular level, structure-activity relationships, drug absorption, distribution, metabolism, elimination, toxicology and pharmacogenomics. In general, special volumes are edited by well known guest editors



Handbook of Process Chromatography

Handbook of Process Chromatography Author G. K. Sofer
ISBN-10 012654266X
Release 1997
Pages 387
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This handbook is an excellent reference for graduates and researchers in biotechnology and practitioners in the pharmaceutical industry who wish to develop a commercial chromatographic purification process. The authors guide readers through each step of the development process, beginning with basic chromatography theory and practice and incorporating examples from companies with established processes and approved biotherapeutics. They also cover properties of biological molecules, and reveal pitfalls often encountered in the process. Design strategies are discussed in depth, considering common starting materials and their impact on purification design, scale-up concerns, and validation. The authors use their extensive consulting and teaching experience to present a practical approach to developing an optimal chromatographic process, scaling it up, and meeting requirements set forth by regulatory agencies. The included diskette contains modeling exercises providing valuable insights into the influence of chromatographic parameters on separation results and the impact of process design on production costs, making the Handbook an excellent hands-on teaching tool. Key Features * Considers the entire scope of process chromatography, including scale up, regulatory issues, equipment, evaluation studies, scheduling, and cost-effectiveness * Provides examples from companies with established processes and approved biotherapeutics * Includes an appendix which lists the most pertinent regulatory documents, allowing the user to gather necessary information to comply with global regulatory expectations for process chromatography * Contains a modeling program on the included disk



Manufacturing of Pharmaceutical Proteins

Manufacturing of Pharmaceutical Proteins Author Stefan Behme
ISBN-10 9783527683086
Release 2015-03-20
Pages 456
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Structured like a textbook, the second edition of this reference covers all aspects of biopharmaceutical manufacturing, including legal and regulatory issues, production facility design, and quality assurance, with a focus on supply chain management and regulations in emerging markets and cost control. The author has longstanding industrial expertise in biopharmaceutical production and years of experience teaching at universities. As such, this practical book is ideal for use in academia as well as for internal training within companies.



Continuous Manufacturing of Pharmaceuticals

Continuous Manufacturing of Pharmaceuticals Author Peter Kleinebudde
ISBN-10 9781119001324
Release 2017-09-05
Pages 620
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10.7.3 State of Control



Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook Author Shayne Cox Gad
ISBN-10 0470259809
Release 2008-03-21
Pages 1384
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This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.



Handbook of Stability Testing in Pharmaceutical Development

Handbook of Stability Testing in Pharmaceutical Development Author Kim Huynh-Ba
ISBN-10 9780387856278
Release 2008-11-16
Pages 389
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This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.



Handbook of Downstream Processing

Handbook of Downstream Processing Author E. Goldberg
ISBN-10 9789400915633
Release 2012-12-06
Pages 720
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The last two decades have seen a phenomenal growth of the field of genetic or biochemical engineering and have witnessed the development and ultimately marketing of a variety of products-typically through the manipulation and growth of different types of microorganisms, followed by the recovery and purification of the associated products. The engineers and biotechnologists who are involved in the full-scale process design of such facilities must be familiar with the variety of unit operations and equipment and the applicable regulatory requirements. This book describes current commercial practice and will be useful to those engineers working in this field in the design, construction and operation of pharmaceutical and biotechnology plants. It will be of help to the chemical or pharmaceutical engineer who is developing a plant design and who faces issues such as: Should the process be batch or continuous or a combination of batch and continuous? How should the optimum process design be developed? Should one employ a new revolutionary separation which could be potentially difficult to validate or use accepted technology which involves less risk? Should the process be run with ingredients formulated from water for injection, deionized water, or even filtered tap water? Should any of the separations be run in cold rooms or in glycol jacketed lines to minimize microbial growth where sterilization is not possible? Should the process equipment and lines be designed to be sterilized in-place, cleaned-in-place, or should every piece be broken down, cleaned and autoclaved after every turn?



Analytical Method Validation and Instrument Performance Verification

Analytical Method Validation and Instrument Performance Verification Author Chung Chow Chan
ISBN-10 047146371X
Release 2004-04-23
Pages 320
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Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.



Fermentation and Biochemical Engineering Handbook

Fermentation and Biochemical Engineering Handbook Author Celeste M. Todaro
ISBN-10 9781455730469
Release 2014-03-27
Pages 454
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A complete reference for fermentation engineers engaged in commercial chemical and pharmaceutical production, Fermentation and Biochemical Engineering Handbook emphasizes the operation, development and design of manufacturing processes that use fermentation, separation and purification techniques. Contributing authors from companies such as Merck, Eli Lilly, Amgen and Bristol-Myers Squibb highlight the practical aspects of the processes—data collection, scale-up parameters, equipment selection, troubleshooting, and more. They also provide relevant perspectives for the different industry sectors utilizing fermentation techniques, including chemical, pharmaceutical, food, and biofuels. New material in the third edition covers topics relevant to modern recombinant cell fermentation, mammalian cell culture, and biorefinery, ensuring that the book will remain applicable around the globe. It uniquely demonstrates the relationships between the synthetic processes for small molecules such as active ingredients, drugs and chemicals, and the biotechnology of protein, vaccine, hormone, and antibiotic production. This major revision also includes new material on membrane pervaporation technologies for biofuels and nanofiltration, and recent developments in instrumentation such as optical-based dissolved oxygen probes, capacitance-based culture viability probes, and in situ real-time fermentation monitoring with wireless technology. It addresses topical environmental considerations, including the use of new (bio)technologies to treat and utilize waste streams and produce renewable energy from wastewaters. Options for bioremediation are also explained. Fully updated to cover the latest advances in recombinant cell fermentation, mammalian cell culture and biorefinery, along with developments in instrumentation Industrial contributors from leading global companies, including Merck, Eli Lilly, Amgen, and Bristol-Myers Squibb Covers synthetic processes for both small and large molecules



Process Scale Bioseparations for the Biopharmaceutical Industry

Process Scale Bioseparations for the Biopharmaceutical Industry Author Abhinav A. Shukla
ISBN-10 9781420016024
Release 2006-07-07
Pages 575
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The biopharmaceutical industry has become an increasingly important player in the global economy, and the success of these products depends on the development and implementation of cost-effective, robust and scaleable production processes. Bioseparations-also called downstream processing- can be a key source of competitive advantageto biopharmaceutical developers. Process Scale Bioseparations for the Biopharmaceutical Industry brings together scientific principles, empirical approaches, and practical considerations for designing industrial downstream bioprocesses for various classes of biomolecules. Using clear language along with numerous case studies, examples, tables, flow charts, and schematics, the book presents perspectives from experienced professionals involved in purification processes and industrial downstream unit operations. The authors provide useful experimental design strategies and guidelines for developing application-specific process scale bioseparations. Chapter topics include harvest by centrifugation and filtration, expanded bed chromatography, protein refolding, modes of preparative chromatography, methodologies for resin screening, membrane chromatography, protein crystallization, viral filtration, ultrafiltration/diafiltration, implementing post-approval downstream process changes for an antibody product, and future trends. Ideal for both new and experienced scientists in the biopharmaceutical industry and students, Process Scale Bioseparations for the Biopharmaceutical Industry is a comprehensive resource for all topics relevant to industrial process development.



Validation of Pharmaceutical Processes Third Edition

Validation of Pharmaceutical Processes  Third Edition Author James P. Agalloco
ISBN-10 1420019791
Release 2007-09-25
Pages 760
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Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine validation and six sigma system design; the preparation of aseptic and non-aseptic pharmaceutical products; active pharmaceutical ingredient and biotechnology processes, computerized systems; qualification and cleaning of equipment; analytical methods, calibration and certification. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded is a comprehensive analysis of all of the fundamental elements of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process. Presenting theoretical knowledge and applied practical considerations, this title provides an in-depth discussion of recent advances in sterilization identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions



Leachables and Extractables Handbook

Leachables and Extractables Handbook Author Douglas J. Ball
ISBN-10 9780470173657
Release 2012-01-24
Pages 700
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"Because leachables are non-drug-related impurities, there are increased concerns regarding the risks of inhaling them on a daily basis. This book describes the development and application of safety thresholds for Orally Inhaled and Nasal Drug Products (OINDP). It discusses best practices for evaluation and management of leachables and extractables throughout the pharma product lifecycle by providing practical knowledge about how and why safety thresholds were developed. This book also illustrates how to apply these concepts and principles to products beyond OINDP, and includes an appendix of experimental protocols for laboratory analysis"--Provided by publisher.



The Medical Device R D Handbook

The Medical Device R D Handbook Author Theodore R. Kucklick
ISBN-10 9781420038354
Release 2005-11-21
Pages 376
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The Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices. Detailed information on such diverse topics as catheter building, prototyping, materials, processes, regulatory issues, and much more are available in this convenient handbook for the first time. The Medical Device R&D Handbook also includes exclusive interviews with pioneers and leaders in the medical device industry, offering an insider's perspective on issues that are critical to the medical device entrepreneur. Highlights Include... An Introduction to Medical Plastics Catheter Forming Equipment and Operations Basics of Catheter Construction Basics of Medical Needles Rapid Prototyping for Medical Devices Reverse Engineering for Medical Devices Using Medical Illustration in Product Development Introduction to Pre-Clinical Studies Introduction to Regulatory Affairs Assessing Biocompatibility Exclusive Interviews with Key Industry Leaders ...And More This practical handbook is a unique, insightful guide that helps you design, test, and successfully introduce new medical devices to the marketplace.



Handbook of Analytical Instruments

Handbook of Analytical Instruments Author R S Khandpur
ISBN-10 9789339221362
Release
Pages
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Handbook of Analytical Instruments has been writing in one form or another for most of life. You can find so many inspiration from Handbook of Analytical Instruments also informative, and entertaining. Click DOWNLOAD or Read Online button to get full Handbook of Analytical Instruments book for free.