Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Author: Feroz Jameel,Susan Hershenson

Publisher: John Wiley & Sons

ISBN: 0470595876

Category: Science

Page: 976

View: 7596

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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Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Pharmaceutical sciences, Pharmaceutical sciences

Author: CTI Reviews

Publisher: Cram101 Textbook Reviews

ISBN: 1467226246

Category: Education

Page: 54

View: 2676

Facts101 is your complete guide to Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals. In this book, you will learn topics such as as those in your book plus much more. With key features such as key terms, people and places, Facts101 gives you all the information you need to prepare for your next exam. Our practice tests are specific to the textbook and we have designed tools to make the most of your limited study time.
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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: 1023

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: 3527336826

Category: Science

Page: 504

View: 8991

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: 687

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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Der gleichläufige Doppelschneckenextruder

Grundlagen, Technologie, Anwendungen

Author: Klemens Kohlgrüber

Publisher: Carl Hanser Verlag GmbH Co KG

ISBN: 3446452354

Category: Technology & Engineering

Page: 842

View: 3153

Alles zum gleichläufigen Doppelschneckenextruder Bei der Herstellung von Kunststoffen, insbesondere bei der Aufbereitung und Verarbeitung bis zum Fertigprodukt werden Extruder eingesetzt, wobei der gleichläufige Doppelschneckenextruder eine dominante Rolle spielt. Aber auch in anderen Industriezweigen, z. B. der Kautschuk- und Lebensmittelindustrie und zunehmend in der Pharmaindustrie kommen die Gleichdrallschnecken vielfältig zum Einsatz. Eine multifunktionale Maschine Das Fachbuch gibt umfassenden Einblick in die verfahrens- und maschinentechnischen Grundlagen und legt großen Fokus auf Praxisbeispiele. Meist sind die Schnecken modular aufgebaut und können damit sehr flexibel an veränderte Aufgabenstellung und Produkteigenschaften angepasst werden. Für die optimale Auslegung eines Doppelschneckenextruders sind vertiefte Kenntnisse über die Maschine und den Prozess erforderlich. Ein Praxisbuch für Einsteiger und Profis Die zweite Auflage entstand unter Mitwirkung vieler Fachautoren von renommierten Firmen und Hochschulen. Alle inzwischen erfolgten Weiterentwicklungen wurden berücksichtigt. Die zweite Auflage wurde durchgehend neu bearbeitet, ist deutlich erweitert, komplett in Farbe und in neuem Layout. Mit Zusatzmaterial auf der Website des Herausgebers: Videos, Bilder, Beispiel-Aufgaben, Rechentools EXTRA: E-Book inside
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Handbook of Pharmaceutical Biotechnology

Author: Shayne Cox Gad

Publisher: John Wiley & Sons

ISBN: 9780470117101

Category: Medical

Page: 1680

View: 3118

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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Development of Biopharmaceutical Parenteral Dosage Forms

Author: Cosimo Prantera,Burton I. Korelitz

Publisher: CRC Press

ISBN: 0585378002

Category: Medical

Page: 264

View: 4385

This up-to-the-minute reference delineates-in a systematic fashion-the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products-covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process. Written by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Forms details biopharmaceuticals that are licensed or undergoing clinical development, including genetically engineered cell and engineered vectors in the fermentation process describes purification and characterization techniques for rDNA therapeutics, discussing several types of unit operations for isolation, purification, and characterization considers preformulation and formulation requirements, such as physicochemical properties, drug delivery, stability studies programs, deactivation/denaturation routes, selection of compatible excipients, and regulatory compliance elucidates basics of analytical techniques, methods development, separation methods using chromatographic and electrophoretic techniques, and bioactivity methods covering bioassays and immunoassays for quantifying the stability of biological activity shows how to select the appropriate filter for maximizing compatibility and minimizing adsorption and inactivation, examining topics from basic filtration theories to future trends reviews the selection process for compatible elastomeric closures, analyzing physical, chemical, toxicological properties, protein adsorption on elastomeric surfaces, strategies to reduce/eliminate adsorption, and specialized containers for biotechnological applications and more! Furnished with helpful references, tables, and drawings, this practical guide is indispensable for pharmaceutical, medicinal, and protein chemists; molecular biologists; process engineers; purification scientists; biopharmaceutical and pharmaceutical formulators and product developers; quality control, quality assurance, and regulatory compliance personnel; and upper-level undergraduate and graduate students in these disciplines.
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Process Validation in Manufacturing of Biopharmaceuticals

Guidelines, Current Practices, and Industrial Case Studies

Author: Gail Sofer

Publisher: CRC Press

ISBN: 1420001655

Category: Science

Page: 402

View: 3418

A study of biopharmaceutical process validation. It aims to enable developers and producers to ensure safe products, reduce the risk of adverse reactions in patients, and avoid recalls by outlining sophisticated validation approaches to characterize processes, process intermediates, and final product fully. The text emphasizes cost effectiveness while determining what level of validation is required for different phases of development, license application, and process improvements.
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New Bioprocessing Strategies: Development and Manufacturing of Recombinant Antibodies and Proteins

Author: Bob Kiss,Uwe Gottschalk,Michael Pohlscheidt

Publisher: Springer

ISBN: 3319971107

Category: Science

Page: 469

View: 9261

This book review series presents current trends in modern biotechnology. The aim is to cover all aspects of this interdisciplinary technology where knowledge, methods and expertise are required from chemistry, biochemistry, microbiology, genetics, chemical engineering and computer science. Volumes are organized topically and provide a comprehensive discussion of developments in the respective field over the past 3-5 years. The series also discusses new discoveries and applications. Special volumes are dedicated to selected topics which focus on new biotechnological products and new processes for their synthesis and purification. In general, special volumes are edited by well-known guest editors. The series editor and publisher will however always be pleased to receive suggestions and supplementary information. Manuscripts are accepted in English.
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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: 4464

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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Pharmakokinetik

Eine Einführung

Author: Erich Gladtke,Hans Michael von Hattingberg

Publisher: Springer-Verlag

ISBN: 3662092727

Category: Medical

Page: 148

View: 2589

Die Herausgeber dieses Büchleins sind bzw. waren meine langjährigen Mitarbeiter und haben sich überwiegend mit der praktischen und ange wandten Pharmakokinetik beschäftigt. Aus der gemeinsamen Arbeit ergab sich, daß unsere Arbeitsgruppe immer wieder zu Fortbildungsvor trägen und Einführungskursen über das Gebiet der Pharmakokinetik gebeten wurde. Diese Veranstaltungen waren vor allem für jene gedacht, die sich bisher noch nicht mit der Pharmakokinetik beschäftigt hatten, die also wissen wollten, um was es sich bei dieser Materie überhaupt handelt. Beim ersten Hinsehen erscheinen manchem Mediziner und Biologen die Formulierungen und mathematischen Ableitungen, wie sie in einigen diesbezüglichen Arbeiten verwendet werden und wie ich sie in meinen Grundlagen der Pharmakokinetik ausführlich immer wieder bringen mußte, vielleicht zu kompliziert und zu abschreckend. Deshalb begrüße ich es, daß Herr Gladtke und Herr von Hattingberg bewegt werden konnten, den Inhalt dieser Kurse niederzuschreiben. Es soll eine Orientierung und Einführung sein. Sicher werden einige Leser dadurch angeregt, tiefer in jene Materie einzudringen, die ich seinerzeit (1953) Pharmakokinetik genannt habe, ohne zu wissen, daß diese Be zeichnung inzwischen weltweite Bedeutung erlangt haben würde. Damit wäre das Büchlein von Nutzen. Ich darf dies den Autoren wünschen. Gießen, Dezember 1972 F.H. DOST V Vorwort Diese Schrift ist als Einführung in die Pharmakokinetik gedacht und darf damit nicht als Lehrbuch, Nachschlagewerk oder erschöpfende Dar stellung verstanden werden. Der Vorsteher der Sektion antimikrobielle Chemotherapie der Paul Ehr lich-Gesellschaft und Leiter der Abteilung für antimikrobielle Therapie der Universitäts-Kinderklinik München, Herr Professor Dr. med.
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Pharmaceutical Biotechnology

Concepts and Applications

Author: Gary Walsh

Publisher: John Wiley & Sons

ISBN: 111868575X

Category: Science

Page: 504

View: 5997

Pharmaceutical Biotechnology offers students taking Pharmacyand related Medical and Pharmaceutical courses a comprehensiveintroduction to the fast-moving area of biopharmaceuticals. With aparticular focus on the subject taken from a pharmaceuticalperspective, initial chapters offer a broad introduction to proteinscience and recombinant DNA technology- key areas that underpin thewhole subject. Subsequent chapters focus upon the development,production and analysis of these substances. Finally the book moveson to explore the science, biotechnology and medical applicationsof specific biotech products categories. These include not onlyprotein-based substances but also nucleic acid and cell-basedproducts. introduces essential principles underlining modernbiotechnology- recombinant DNA technology and protein science an invaluable introduction to this fast-moving subject aimedspecifically at pharmacy and medical students includes specific ‘product category chapters’focusing on the pharmaceutical, medical and therapeutic propertiesof numerous biopharmaceutical products. entire chapter devoted to the principles of genetic engineeringand how these drugs are developed. includes numerous relevant case studies to enhance studentunderstanding no prior knowledge of protein structure is assumed
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Continuous Processing in Pharmaceutical Manufacturing

Author: Ganapathy Subramanian

Publisher: John Wiley & Sons

ISBN: 3527673709

Category: Medical

Page: 528

View: 1386

With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.
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Manual of Industrial Microbiology and Biotechnology

Author: Richard H. Baltz,Julian E. Davies,Arnold L. Demain

Publisher: American Society for Microbiology Press

ISBN: N.A

Category: Medical

Page: 766

View: 4533

The third edition of this acclaimed manual reviews the newest techniques, approaches, and options in the use of microorganisms and other cell culture systems for the manufacture of pharmaceuticals, industrial enzymes and proteins, foods and beverages, fuels and fine chemicals, and other products.
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Lyophilized Biologics and Vaccines

Modality-Based Approaches

Author: Dushyant Varshney,Manmohan Singh

Publisher: Springer

ISBN: 1493923838

Category: Medical

Page: 401

View: 2226

This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch a lyophilized biologics or vaccine product, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fused), complex biologics (e.g., antibody drug conjugate, PEGylated proteins), and vaccines (e.g., recombinant-protein based). The authors adeptly guide the reader through all crucial aspects, from biophysical and chemical stability considerations of proteins, analytical methods, advances in controlled ice nucleation and quality-by-design approaches, alternate drying technology, to latest regulatory, packaging and technology transfer considerations to develop a stable, safe and effective therapeutic protein, vaccine and biotechnology products. Lyophilized Biologics and Vaccines: Modality-Based Approaches is composed of four sections with a total of 17 chapters. It serves as a reference to all critical assessments and steps from early pre-formulation stages to product launch: Provides recent understanding of heterogeneity of protein environment and selection of appropriate buffer for stabilization of lyophilized formulations Details the latest developments in instrumental analysis and controlled ice nucleation technology Explains in-depth lyophilized (or dehydrated) formulation strategies considering diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics Details an exhaustive update on quality-by-design and process analytical technology approaches, illustrated superbly by case studies and FDA perspective Provides the latest detailed account of alternate drying technologies including spray drying, bulk freeze-drying and crystallization, supported exceptionally by case studies Provides a step-by-step guide through critical considerations during process scale-up, technology transfer, packaging and drug delivery device selection, for a successful lyophilization process validation, regulatory submission and product launch Chapters are written by one or more world-renowned leading authorities from academia, industry or regulatory agencies, whose expertise cover lyophilization of the diverse modalities of biopharmaceuticals. Their contributions are based on the exhaustive review of literature coupled with excellent hands-on experiences in laboratory or GMP setup, making this an exceptional guide to all stages of lyophilized or dehydrated product development.
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