Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Author: Feroz Jameel,Susan Hershenson

Publisher: John Wiley & Sons

ISBN: 0470595876

Category: Science

Page: 976

View: 5509

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A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase–appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.
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Biophysical Methods for Biotherapeutics

Discovery and Development Applications

Author: Tapan K. Das

Publisher: John Wiley & Sons

ISBN: 1118354680

Category: Medical

Page: 376

View: 4167

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With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development. • Helps formulation and analytical scientists in pharma and biotech better understand and use biophysical methods • Chapters organized according to the sequential nature of the drug development process • Helps formulation, analytical, and bioanalytical scientists in pharma and biotech better understand and usestrengths and limitations of biophysical methods • Explains how to use biophysical methods, the information obtained, and what needs to be presented in a regulatory filing, assess impact on quality and immunogenicity • With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development.
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Spray Drying Techniques for Food Ingredient Encapsulation

Author: C. Anandharamakrishnan,Padma Ishwarya S.

Publisher: John Wiley & Sons

ISBN: 1118864271

Category: Technology & Engineering

Page: 312

View: 4828

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Spray drying is a well-established method for transforming liquid materials into dry powder form. Widely used in the food and pharmaceutical industries, this technology produces high quality powders with low moisture content, resulting in a wide range of shelf stable food and other biologically significant products. Encapsulation technology for bioactive compounds has gained momentum in the last few decades and a series of valuable food compounds, namely flavours, carotenoids and microbial cells have been successfully encapsulated using spray drying. Spray Drying Technique for Food Ingredient Encapsulation provides an insight into the engineering aspects of the spray drying process in relation to the encapsulation of food ingredients, choice of wall materials, and an overview of the various food ingredients encapsulated using spray drying. The book also throws light upon the recent advancements in the field of encapsulation by spray drying, i.e., nanospray dryers for production of nanocapsules and computational fluid dynamics (CFD) modeling. Addressing the basics of the technology and its applications, the book will be a reference for scientists, engineers and product developers in the industry.
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Formulation of Disperse Systems

Science and Technology

Author: Tharwat F. Tadros

Publisher: John Wiley & Sons

ISBN: 3527678301

Category: Science

Page: 504

View: 9476

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This book presents comprehensively the science and technology behind the formulation of disperse systems like emulsions, suspensions, foams and others. Starting with a general introduction, the book covers a broad range of topics like the role of different classes of surfactants, stability of disperse systems, formulation of different dispersions, evaluation of formulations and many more. Many examples are included, too. Written by the experienced author and editor Tharwart Tadros, this book is indispensable for every scientist working in the field.
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Development and Manufacture of Protein Pharmaceuticals

Author: Steve L. Nail,Michael J. Akers

Publisher: Springer Science & Business Media

ISBN: 1461505496

Category: Medical

Page: 464

View: 8466

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In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources are available for the pharmaceutical develop ment scientist and other personnel responsible for the commercialization of the finished dosage forms of these new biopharmaceuticals and other products from biotechnology. This text will help to fill this gap. Once active biopharmaceutical molecules are candidates for clinical trial investigation and subsequent commercialization, a number of other activities must take place while research and development on these molecules continues. The active ingredient itself must be formulated into a finished dosage form that can be conveniently used by health care professionals and patients. Properties of the biopharmaceutical molecule must be clearly understood so that the appropriate finished product formulation can be developed. Finished product formulation development includes not only the chemical formulation, but also the packaging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength, purity, and quality.
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Quality by Design for Biopharmaceuticals

Principles and Case Studies

Author: Anurag S. Rathore,Rohin Mhatre

Publisher: John Wiley & Sons

ISBN: 1118210913

Category: Science

Page: 312

View: 4203

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The concepts, applications, and practical issues of Quality byDesign Quality by Design (QbD) is a new framework currently beingimplemented by the FDA, as well as EU and Japanese regulatoryagencies, to ensure better understanding of the process so as toyield a consistent and high-quality pharmaceutical product. QbDbreaks from past approaches in assuming that drug quality cannot betested into products; rather, it must be built into every step ofthe product creation process. Quality by Design: Perspectives and Case Studies presentsthe first systematic approach to QbD in the biotech industry. Acomprehensive resource, it combines an in-depth explanation ofbasic concepts with real-life case studies that illustrate thepractical aspects of QbD implementation. In this single source, leading authorities from thebiotechnology industry and the FDA discuss such topics as: The understanding and development of the product's criticalquality attributes (CQA) Development of the design space for a manufacturingprocess 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 toQbD Relevant PAT tools and applications for the pharmaceuticalindustry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) toQbD Filled with vivid case studies that illustrate QbD at work incompanies today, Quality by Design is a core reference forscientists in the biopharmaceutical industry, regulatory agencies,and students.
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Quality by Design for Biopharmaceutical Drug Product Development

Author: Feroz Jameel,Susan Hershenson,Mansoor A. Khan,Sheryl Martin-Moe

Publisher: Springer

ISBN: 1493923161

Category: Medical

Page: 710

View: 6497

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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.
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Vaccine Development and Manufacturing

Author: Emily P. Wen,Ronald Ellis,Narahari S. Pujar

Publisher: John Wiley & Sons

ISBN: 1118870905

Category: Technology & Engineering

Page: 456

View: 9174

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Vaccine Manufacturing and Production is an invaluablereference on how to produce a vaccine - from beginning to end -addressing all classes of vaccines from aprocessing, production, and regulatory viewpoint. It willprovide comprehensive information on the various fields involved inthe production of vaccines, from fermentation, purification,formulation, to regulatory filing and facility designs. In recentyears, there have been tremendous advances in all aspects ofvaccine manufacturing. Improved technology and growth media havebeen developed for the production of cell culture with high celldensity or fermentation. Vaccine Manufacturing andProduction will serve as a reference on all aspects of vaccineproduction by providing an in-depth description of the availabletechnologies for making different types of vaccines and the currentthinking in facility designs and supply issues. This book willprovide insight to the issues scientists face when producing avaccine, the steps that are involved, and will serve asa reference tool regarding state-of-the-art vaccinemanufacturing technologies and facility set-up. Highlights include: Comprehensive coverage of vaccine production : from a processpoint of view- fermentation to purification to formulationdevelopments; from a production point of view - from facilitydesign to manufacturing; and from a regulatory point of view -requirements from government agencies Authors from different major pharmaceutical and biotechnologycompanies Describes the challenges and issues involved in vaccineproduction and manufacturing of the different classes of vaccines,an area not covered by other books currently on the market
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Handbook of Pharmaceutical Biotechnology

Author: Shayne Cox Gad

Publisher: John Wiley & Sons

ISBN: 9780470117101

Category: Medical

Page: 1680

View: 8555

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A practical overview of a full rangeof approaches to discovering, selecting, and producing biotechnology-derived drugs The Handbook of Pharmaceutical Biotechnology helps pharmaceutical scientists develop biotech drugs through a comprehensive framework that spans the process from discovery, development, and manufacturing through validation and registration. With chapters written by leading practitioners in their specialty areas, this reference: Provides an overview of biotechnology used in the drug development process Covers extensive applications, plus regulations and validation methods Features fifty chapters covering all the major approaches to the challenge of identifying, producing, and formulating new biologically derived therapeutics With its unparalleled breadth of topics and approaches, this handbook is a core reference for pharmaceutical scientists, including development researchers, toxicologists, biochemists, molecular biologists, cell biologists, immunologists, and formulation chemists. It is also a great resource for quality assurance/assessment/control managers, biotechnology technicians, and others in the biotech industry.
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Biotechnology and Biopharmaceutical Manufacturing, Processing, and Preservation

Author: Kenneth E. Avis,Vincent L. Wu

Publisher: CRC Press

ISBN: 9781574910162

Category: Medical

Page: 400

View: 6505

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In this unique book, experts describe practices applicable to the large-scale processing of biotechnological products. Beginning with processing and bulk storage preservation techniques, the book provides strategies for improving efficiency of process campaigns of multiple products and manufacturing facilities for such processing techniques. Large-scale chromatography for the purification of biomolecules in manufacturing and lyophilization of protein pharmaceuticals are discussed. Includes a case study on blow-fill-seal processing technology and a chapter on economic and cost factors for bioprocess engineering.
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