Surfactants In Biopharmaceutical Development

Author : Atanas V. Koulov
Publisher : Academic Press
ISBN 13 : 0128125691
Total Pages : 236 pages
Book Rating : 4.94/5 ( download)

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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

Author : Lars Schiefelbein
Publisher : Cuvillier Verlag
ISBN 13 : 3736938322
Total Pages : 178 pages
Book Rating : 4.28/5 ( download)

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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

Author : Lars Kurt Johann Schiefelbein
Publisher :
ISBN 13 : 9783869558325
Total Pages : 157 pages
Book Rating : 4.26/5 ( download)

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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:

Author : Rajesh Krishna
Publisher : Springer Science & Business Media
ISBN 13 : 038772379X
Total Pages : 416 pages
Book Rating : 4.92/5 ( download)

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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.

Author : Ferdinand Devinsky
Publisher :
ISBN 13 : 9781536119794
Total Pages : 0 pages
Book Rating : 4.92/5 ( download)

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Download or read book Cationic Amphiphiles written by Ferdinand Devinsky and published by . This book was released on 2017-06 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Surfactants play an essential role in our daily lives. Their form of usage varies from detergents and cleaning agents through disinfectants and solubilisers up to industrial applications such as paints, oil recovery, anti-corrosion protective coatings, etc. A special distinct class of surfactants is represented by a double-chain, double-head form of surfactant molecules, which are called gemini surfactants. Gemini surfactants show physicochemical and aggregation properties which are superior to those of conventional, single-chain surfactants. From the perspective of applications, an important group of gemini surfactants is represented by cationic gemini surfactants. They have found numerous applications in the various fields such as solubilisation, textile coating, organic and polymer synthesis, electrochemistry, paper industry, etc. One of the most developing areas of cationic gemini surfactants application is the field of pharmaceutical applications. Interaction of cationic surfactants with the oppositely charged cell membrane has been known for a long time. Cationic gemini surfactants turned out to be very efficient bactericidal and antimicrobial agents. Moreover, recent development in this field indicates a cancerostatic effect of cationic geminis through a selective interaction of cationic gemini molecules with cancer cells. Another revolutionary field of cationic gemini surfactants application is their interaction with an oppositely charged electrolyte such as DNA. The interaction of DNA with various positively charged systems such as cationic surfactants, polymers and lipids is of great importance with respect to gene transmission through a biological cell membrane to achieve a therapeutic effect in a cell nucleus. The ambition of this monograph is to provide a complex view of synthesis, structure-aggregation, properties-biological activity relationship and recent applications of cationic gemini surfactants in the pharmaceutical field. Individual chapters in the monograph discuss the synthetic preparation of cationic surfactants, the effect of the structure of these compounds on their physical and physicochemical properties, particularly their aggregation properties and associated phenomena. A significant part of this publication is devoted to gemini surfactants, a relatively new class of surfactants whose special and surprising properties increasingly continue to draw the attention of the research community. The final part of the monograph is oriented on the use of cationic surfactants in biomedicine and pharmaceutical applications, where a special emphasis is put on their antimicrobial and antineoplastic activities. Finally, cationic surfactants as potent non-viral gene delivery vehicles are analysed and evaluated. The monograph is intended to serve as a guide for scientists and students in the field of pharmaceutical research and chemistry of colloids and surfactants.

Author :
Publisher : ScholarlyEditions
ISBN 13 : 1464963428
Total Pages : 4229 pages
Book Rating : 4.21/5 ( download)

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Download or read book Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition written by and published by ScholarlyEditions. This book was released on 2012-01-09 with total page 4229 pages. Available in PDF, EPUB and Kindle. Book excerpt: Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition is a ScholarlyEditions™ eBook that delivers timely, authoritative, and comprehensive information about Pharmacology, Pharmacy, Drug Research, and Drug Innovation. The editors have built Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Pharmacology, Pharmacy, Drug Research, and Drug Innovation in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.

Author : Nicholas W. Warne
Publisher : Springer
ISBN 13 : 3319906038
Total Pages : 599 pages
Book Rating : 4.34/5 ( download)

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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 599 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.

Author : Alexandre Gomes Rodrigues
Publisher : Elsevier
ISBN 13 : 0444643028
Total Pages : 376 pages
Book Rating : 4.25/5 ( download)

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Download or read book New and Future Developments in Microbial Biotechnology and Bioengineering written by Alexandre Gomes Rodrigues and published by Elsevier. This book was released on 2020-06-10 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: New and Future Developments in Microbial Biotechnology and Bioengineering: Microbial Biomolecules: Properties, Relevance and Their Translational Applications presents a concise review on microbial biotechnology, along with impacts and recent results from research centers, small companies and large enterprises. The book brings the most relevant information on how we can use resources - in this case from microorganisms - and technology to develop solutions in fields like biofuels, food, cosmetics and medicine. It covers case studies of start-ups in the field and explains how scientists have moved their ideas into profitable bio-based products that are necessary for our current living standards. In addition, the book describes strategic governmental programs designed to exploit biomass in a sustainable way, along with detailed information on research in several high-impact, worldwide laboratories. It gives concrete examples of ongoing research from molecules to methods, such as L-asparaginase, extremophiles, new diagnostics tools and the analytical methods that have raised the quality of the data obtained, thereby boosting the so-called bioeconomy. Comprises a unique source of information on the various applications of microbial biomolecules Provides resourceful material for new ideas and strong rational/application-oriented stories Discusses biotech companies in various areas (biofuel, food, medicine, etc.) who are actively using microbial biomolecules Outlines scientific discoveries and their translation into profitable products Gives an insight perspective of institutional and governmental strategic research programs aiming to preserve, explore and generate benefits from microbial biomolecules

Author : Gregory K. Webster
Publisher : CRC Press
ISBN 13 : 1315340860
Total Pages : 728 pages
Book Rating : 4.69/5 ( download)

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Download or read book Poorly Soluble Drugs written by Gregory K. Webster and published by CRC Press. This book was released on 2017-01-06 with total page 728 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is the first text to provide a comprehensive assessment of the application of fundamental principles of dissolution and drug release testing to poorly soluble compounds and formulations. Such drug products are, vis-à-vis their physical and chemical properties, inherently incompatible with aqueous dissolution. However, dissolution methods are required for product development and selection, as well as for the fulfillment of regulatory obligations with respect to biopharmaceutical assessment and product quality understanding. The percentage of poorly soluble drugs, defined in classes 2 and 4 of the Biopharmaceutics Classification System (BCS), has significantly increased in the modern pharmaceutical development pipeline. This book provides a thorough exposition of general method development strategies for such drugs, including instrumentation and media selection, the use of compendial and non-compendial techniques in product development, and phase-appropriate approaches to dissolution development. Emerging topics in the field of dissolution are also discussed, including biorelevant and biphasic dissolution, the use on enzymes in dissolution testing, dissolution of suspensions, and drug release of non-oral products. Of particular interest to the industrial pharmaceutical professional, a brief overview of the formulation and solubilization techniques employed in the development of BCS class 2 and 4 drugs to overcome solubility challenges is provided and is complemented by a collection of chapters that survey the approaches and considerations in developing dissolution methodologies for enabling drug delivery technologies, including nanosuspensions, lipid-based formulations, and stabilized amorphous drug formulations.

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 0470249021
Total Pages : 1352 pages
Book Rating : 4.24/5 ( download)

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Download or read book Preclinical Development Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-03-21 with total page 1352 pages. Available in PDF, EPUB and Kindle. Book excerpt: A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques. Each chapter is written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor has carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * Modeling and informatics in drug design * Bioanalytical chemistry * Absorption of drugs after oral administration * Transporter interactions in the ADME pathway of drugs * Metabolism kinetics * Mechanisms and consequences of drug-drug interactions Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This publication should be readily accessible to all pharmaceutical scientists involved in preclinical testing, enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.