Surfactants In Biopharmaceutical Development

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Surfactants in Biopharmaceutical Development

Author : Atanas V. Koulov
Publisher : Academic Press
ISBN 13 : 0128125691
Total Pages : 236 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Surfactants in Biopharmaceutical Development by : Atanas V. Koulov

Download or read book Surfactants in Biopharmaceutical Development written by Atanas V. Koulov and published by Academic Press. This book was released on 2023-08-25 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Surfactants in Biopharmaceutical Development addresses the progress, challenges and opportunities for surfactant research specific to pharmaceutical development, providing a broad range of important surfactant-related topics as they relate directly to the biopharmaceutical process. Chapters address fundamental topics, like mechanisms of protein stabilization by surfactants, the latest, state-of-the-art technology and methods to illustrate the practical application to biopharmaceutical development, forward-looking chapters on control strategies and novel surfactants, with a special focus on current regulatory aspects of paramount importance for biopharmaceutical companies and regulators. It has been widely recognized that surfactants provide protection to therapeutic proteins against interfacial stresses. Despite the fact that the very mechanism of protein stabilization by surfactants has not been completely understood, surfactants are universally regarded as critical functional excipients by the industry and by regulators. Describes the current state of research on surfactants in the context of biopharmaceutical development, drawing upon contributions from international experts across industry, academia, and regulators Addresses the opportunities and challenges associated with surfactants in biologic drug development Provides a defining resource for practitioners in the biopharmaceutical industry, regulators and academics by summarizing the latest knowledge of surfactants in biopharmaceutical development in one comprehensive volume

Surfactant Systems

Author : D. Attwood
Publisher : Springer Science & Business Media
ISBN 13 : 9400957750
Total Pages : 802 pages
Book Rating : 4.4/5 (9 download)

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Book Synopsis Surfactant Systems by : D. Attwood

Download or read book Surfactant Systems written by D. Attwood and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 802 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is now twelve years since Solubilization by Surface-Active Agents appeared. Since the publication of that monograph the subject has expanded rapidly as the unique potential of surfactants has become known to a wider circle of scientists. In a recent review Menger (Accounts of Chemical Research, 12 (1979) 111) estimated that since 1970 there have been over 2800 publications on micelles and micellization alone. The topic of catalysis in micellar media was in an early stage of development in 1968 but the growth in this subject has given rise to an excellent textbook by Fendler and Fendler. We have felt for some time that a revision of Solubilization by Surface-Active Agents was overdue. The book has been out of print for some time. Owing to pressure of other work, Professor P. H. Elworthy and Dr C. B. Macfarlane were unable to undertake the work of revision but while working together on an undergraduate textbook the present authors decided to set to work, realizing both the impossibility of producing a comprehensive textbook and the need to alter the scope of the book. Micellar solubilization occurs over a relatively small surfactant concentration range; because of this and because the phenomenon is never observed in isolation, we have extended the text to include surface activity, emulsions and suspensions and, as our emphasis is on formulation of medicinal products, to the of the toxicology of surface-active agents.

Sugar-Based Surfactants for Pharmaceutical Protein Formulations

Author : Lars Schiefelbein
Publisher : Cuvillier Verlag
ISBN 13 : 3736938322
Total Pages : 178 pages
Book Rating : 4.7/5 (369 download)

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Book Synopsis Sugar-Based Surfactants for Pharmaceutical Protein Formulations by : Lars Schiefelbein

Download or read book Sugar-Based Surfactants for Pharmaceutical Protein Formulations written by Lars Schiefelbein and published by Cuvillier Verlag. This book was released on 2011-07-25 with total page 178 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nonionic Surfactants, Sugar-Based Surfactants, Alkylpolyglucosides, Protein Formulations

Fast Dynamic Surfactant Reduces Aggregation of Biologics

Author : Joshua S Katz
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (116 download)

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Book Synopsis Fast Dynamic Surfactant Reduces Aggregation of Biologics by : Joshua S Katz

Download or read book Fast Dynamic Surfactant Reduces Aggregation of Biologics written by Joshua S Katz and published by . This book was released on 2017 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: As the pharmaceutical industry shifts from small molecule drug to biologic drug development, new and unique formulation needs emerge. Issues relating to shelf-stability of biologic formulations remain a key challenge to new drug development for both the developed and developing world. N-myristoyl phenylalanine Jeffamine M1000 diamide (FM1000) is a new experimental surfactant that has been developed for stabilizing biopharmaceuticals. FM1000 exhibits an order of magnitude faster interfacial dynamics than conventional formulation excipients, leading to improved agitation stability. A three-fold drop in IgG aggregation rate was observed for IgG formulated with FM1000 compared to control surfactant formulations. In a study of abatacept aggregation, FM1000 minimized the monomer loss both in glass vials and in IV bags, even out-performing Poloxamer 188, the incumbent technology. FM1000 also reduced subvisible particle formation in a cetuximab model formulation. Coupling aggregation performance with fundamental surfactant interfacial dynamics and behavior will help better understand the underlying mechanisms of protein (de)stabilization, enabling the development of higher stability formulations.

Recent Developments in the Analysis of Surfactants

Author : M.R. Porter
Publisher : Springer
ISBN 13 :
Total Pages : 240 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Recent Developments in the Analysis of Surfactants by : M.R. Porter

Download or read book Recent Developments in the Analysis of Surfactants written by M.R. Porter and published by Springer. This book was released on 1991 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Biobased Surfactants

Author : Douglas G. Hayes
Publisher : Elsevier
ISBN 13 : 0128127066
Total Pages : 541 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Biobased Surfactants by : Douglas G. Hayes

Download or read book Biobased Surfactants written by Douglas G. Hayes and published by Elsevier. This book was released on 2019-04-30 with total page 541 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biobased Surfactants: Synthesis, Properties, and Applications, Second Edition, covers biosurfactant synthesis and applications and demonstrates how to reduce manufacturing and purification costs, impurities, and by-products. Fully updated, this book covers surfactants in biomedical applications, detergents, personal care, food, pharmaceuticals, cosmetics, and nanotechnology. It reflects on the latest developments in biobased surfactant science and provides case scenarios to guide readers in efficient and effective biobased surfactant application, along with strategies for research into new applications. This book is written from a biorefinery-based perspective by an international team of experts and acts as a key text for researchers and practitioners involved in the synthesis, utilization, and development of biobased surfactants. Describes new and emerging biobased surfactants and their synthesis and development Showcases an interdisciplinary approach to the topic, featuring applications to chemistry, biotechnology, biomedicine, and other areas Presents the entire lifecycle of biobased surfactants in detail

Recent Developments in the Technology of Surfactants

Author : M.R. Porter
Publisher :
ISBN 13 :
Total Pages : 224 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Recent Developments in the Technology of Surfactants by : M.R. Porter

Download or read book Recent Developments in the Technology of Surfactants written by M.R. Porter and published by . This book was released on 1990-10-31 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Sugar-based Surfactants for Pharmaceutical Protein Formulations

Author : Lars Kurt Johann Schiefelbein
Publisher :
ISBN 13 : 9783869558325
Total Pages : 157 pages
Book Rating : 4.5/5 (583 download)

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Book Synopsis Sugar-based Surfactants for Pharmaceutical Protein Formulations by : Lars Kurt Johann Schiefelbein

Download or read book Sugar-based Surfactants for Pharmaceutical Protein Formulations written by Lars Kurt Johann Schiefelbein and published by . This book was released on 2011 with total page 157 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Discovering and Developing Molecules with Optimal Drug-Like Properties

Author : Allen C Templeton
Publisher : Springer
ISBN 13 : 1493913999
Total Pages : 510 pages
Book Rating : 4.4/5 (939 download)

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Book Synopsis Discovering and Developing Molecules with Optimal Drug-Like Properties by : Allen C Templeton

Download or read book Discovering and Developing Molecules with Optimal Drug-Like Properties written by Allen C Templeton and published by Springer. This book was released on 2014-10-31 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: This authoritative volume provides a contemporary view on the latest research in molecules with optimal drug-like properties. It is a valuable source to access current best practices as well as new research techniques and strategies. Written by leading scientists in their fields, the text consists of fourteen chapters with an underlying theme of early collaborative opportunities between pharmaceutical and discovery sciences. The book explores the practical realities of performing physical pharmaceutical and biopharmaceutical research in the context of drug discovery with short timelines and low compound availability. Chapters cover strategies and tactics to enable discovery as well as predictive approaches to establish, understand and communicate risks in early development. It also examines the detection, characterization, and assessment of risks on the solid state properties of advanced discovery and early development candidates, highlighting the link between solid state properties and critical development parameters such as solubility and stability. Final chapters center on techniques to improve molecular solubilization and prevent precipitation, with particularly emphasis on linking physiochemical properties of molecules to formulation selection in preclinical and clinical settings.

Surfactant Systems

Author : D. Attwood
Publisher : Springer
ISBN 13 : 9789400957770
Total Pages : 794 pages
Book Rating : 4.9/5 (577 download)

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Book Synopsis Surfactant Systems by : D. Attwood

Download or read book Surfactant Systems written by D. Attwood and published by Springer. This book was released on 2011-11-18 with total page 794 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is now twelve years since Solubilization by Surface-Active Agents appeared. Since the publication of that monograph the subject has expanded rapidly as the unique potential of surfactants has become known to a wider circle of scientists. In a recent review Menger (Accounts of Chemical Research, 12 (1979) 111) estimated that since 1970 there have been over 2800 publications on micelles and micellization alone. The topic of catalysis in micellar media was in an early stage of development in 1968 but the growth in this subject has given rise to an excellent textbook by Fendler and Fendler. We have felt for some time that a revision of Solubilization by Surface-Active Agents was overdue. The book has been out of print for some time. Owing to pressure of other work, Professor P. H. Elworthy and Dr C. B. Macfarlane were unable to undertake the work of revision but while working together on an undergraduate textbook the present authors decided to set to work, realizing both the impossibility of producing a comprehensive textbook and the need to alter the scope of the book. Micellar solubilization occurs over a relatively small surfactant concentration range; because of this and because the phenomenon is never observed in isolation, we have extended the text to include surface activity, emulsions and suspensions and, as our emphasis is on formulation of medicinal products, to the of the toxicology of surface-active agents.

Biobased Surfactants and Detergents

Author : Douglas Hayes
Publisher : AOCS Publishing
ISBN 13 : 9781893997677
Total Pages : 0 pages
Book Rating : 4.9/5 (976 download)

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Book Synopsis Biobased Surfactants and Detergents by : Douglas Hayes

Download or read book Biobased Surfactants and Detergents written by Douglas Hayes and published by AOCS Publishing. This book was released on 2010-01-27 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an overview of biobased surfactants currently under development. The first chapter provides an overview of biobased surfactant research and development in the industrial sector, including synthesis, applications, and current trends and directions in the field. Several chapters describe the current state-of-the-art of biosurfactants, natural amphiphiles synthesized by microorganisms, including their synthesis and applications. An additional focus area is on the application of biobased surfactants as lung surfactants. Many chapters involve the chemical and enzymatic synthesis and applications of biobased surfactants consisting of polyols derived from nature, particularly, mono- and di-saccharides and amino acids. The employment of enzymes as catalysts to direct the synthesis of biobased surfactants is particularly attractive due the reduction of solvent and energy use during the surfactants’ manufacture, and the reduction of purification costs and formation of impurities and by-products.

Surfactants in Consumer Products

Author : Jürgen Falbe
Publisher : Springer
ISBN 13 : 9783642715471
Total Pages : 0 pages
Book Rating : 4.7/5 (154 download)

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Book Synopsis Surfactants in Consumer Products by : Jürgen Falbe

Download or read book Surfactants in Consumer Products written by Jürgen Falbe and published by Springer. This book was released on 2011-11-17 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: In to days market, custom formulated surfactants are offered for a wide range of applications. The need for surfactants in detergents, cleaning agents, cosmetics & toiletries is second only to an expanding demand in industrial applications. But even within the non-industrial areas the demands have undergone significant changes in recent years. For example, washing and cleaning temperatures have substantially decreased with increased energy conservation attitudes, and more stringent regulatory requirements in the area of ecology and toxicology are leading to new product profiles. New manufacturing technologies and an increased utilization of natural raw materials also factor into this continuing evolution. These changes and trends have been described in numerous publications. However, a summary and survey of these developments is currently missing. The book presented here "Surfactants in Consumer Products" is intended to close this gap. The editor and authors dedicate this work to Dr. Dr. h.c. Konrad Henkel on the occasion of his 70th birthday. Dr. Henkel, himself a scientist and industrialist, contributed signifi cantly to developments in the surfactant field. In the nineteen-fifties, he initiated the change from soap based detergents to synthetic detergents within Henkel. At the same time, dishwashing detergents utilizing various synthetic surfactants were also developed, and became the basis for modem manual and mechanical dishwashing.

Biopharmaceutics Applications in Drug Development

Author : Rajesh Krishna
Publisher : Springer Science & Business Media
ISBN 13 : 038772379X
Total Pages : 416 pages
Book Rating : 4.3/5 (877 download)

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Book Synopsis Biopharmaceutics Applications in Drug Development by : Rajesh Krishna

Download or read book Biopharmaceutics Applications in Drug Development written by Rajesh Krishna and published by Springer Science & Business Media. This book was released on 2007-09-20 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: The highly experienced authors here present readers with step-wise, detail-conscious information to develop quality pharmaceuticals. The book is made up of carefully crafted sections introducing key concepts and advances in the areas of dissolution, BA/BE, BCS, IVIC, and product quality. It provides a specific focus on the integration of regulatory considerations and includes case histories highlighting the biopharmaceutics strategies adopted in development of successful drugs.

Development and Manufacture of Protein Pharmaceuticals

Author : Steve L. Nail
Publisher : Springer Science & Business Media
ISBN 13 : 1461505496
Total Pages : 479 pages
Book Rating : 4.4/5 (615 download)

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Book Synopsis Development and Manufacture of Protein Pharmaceuticals by : Steve L. Nail

Download or read book Development and Manufacture of Protein Pharmaceuticals written by Steve L. Nail and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Industrial Applications of Surfactants IV

Author : D. R. Karsa
Publisher :
ISBN 13 : 9780854047734
Total Pages : 0 pages
Book Rating : 4.0/5 (477 download)

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Book Synopsis Industrial Applications of Surfactants IV by : D. R. Karsa

Download or read book Industrial Applications of Surfactants IV written by D. R. Karsa and published by . This book was released on 1999 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Surfactants are used across the whole spectrum of industry, from the formulation of cleaning products, paints and agrochemicals to use in oil fields. This volume creates an invaluable source of practical information on this important class of chemicals. Environmental considerations are increasingly shaping the development of many industries. Industrial Applications of Surfactants IV gives a useful overview of surfactants and the environment, and goes on to look at new surfactants derived from renewable, 'natural' resources such as sucrose, seaweed and starch. Other chapters review a decade of change in the surfactant industry and assess future market trends. Some of the latest developments in surfactant technology are presented, including 'gemini' twin-chained surfactants, sulfobetaines, alkyl phosphates and the use of alkyl alkoxylates and alkyl glucosides in highly alkaline solutions. This volume takes a practical approach throughout. It provides valuable information on recent developments for all those who use or produce surfactants, whether from a technical or a commercial background.

Development of Biopharmaceutical Parenteral Dosage Forms

Author : Cosimo Prantera
Publisher : CRC Press
ISBN 13 : 0585378002
Total Pages : 265 pages
Book Rating : 4.5/5 (853 download)

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Book Synopsis Development of Biopharmaceutical Parenteral Dosage Forms by : Cosimo Prantera

Download or read book Development of Biopharmaceutical Parenteral Dosage Forms written by Cosimo Prantera and published by CRC Press. This book was released on 1997-07-25 with total page 265 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 Formsdetails 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.

Challenges in Protein Product Development

Author : Nicholas W. Warne
Publisher : Springer
ISBN 13 : 3319906038
Total Pages : 596 pages
Book Rating : 4.3/5 (199 download)

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Book Synopsis Challenges in Protein Product Development by : Nicholas W. Warne

Download or read book Challenges in Protein Product Development written by Nicholas W. Warne and published by Springer. This book was released on 2018-06-20 with total page 596 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.