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Author: Atanas V. Koulov
Publisher: Academic Press
ISBN: 0128125691
Category : Medical
Languages : en
Pages : 236
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Book Description
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: Atanas V. Koulov
Publisher: Academic Press
ISBN: 0128125691
Category : Medical
Languages : en
Pages : 236
Get Book Here
Book Description
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: Nicholas W. Warne
Publisher: Springer
ISBN: 3319906038
Category : Medical
Languages : en
Pages : 596
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Book Description
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:
Publisher: ScholarlyEditions
ISBN: 1464963428
Category : Medical
Languages : en
Pages : 4231
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Book Description
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: Alexandru Mihai Grumezescu
Publisher: William Andrew
ISBN: 0128136286
Category : Science
Languages : en
Pages : 769
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Book Description
Design and Development of New Nanocarriers focuses on the design and development of new nanocarriers used in pharmaceutical applications that have emerged in recent years. In particular, the pharmaceutical uses of microfluidic techniques, supramolecular design of nanocapsules, smart hydrogels, polymeric micelles, exosomes and metal nanoparticles are discussed in detail. Written by a diverse group of international researchers, this book is a valuable reference resource for those working in both biomaterials science and the pharmaceutical industry. - Shows how nanomanufacturing techniques can help to create more effective, cheaper pharmaceutical products - Explores how nanofabrication techniques developed in the lab have been translated to commercial applications in recent years - Explains safety and regulatory aspects of the use of nanomanufacturing processes in the pharmaceutical industry
Author: R.Z. Sayyed
Publisher: CRC Press
ISBN: 104032536X
Category : Business & Economics
Languages : en
Pages : 641
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Book Description
Biosurfactants and bioemulsifiers are considered green molecules as they are produced from microbes and are easily degradable as compared to surfactants. They are suitable due to properties such as low toxicity, tolerance to a wide-range pH level and temperature, high surface activity, biodegradability, excellent emulsifying and demulsifying ability. While, caution and care should be exercised in its widespread usage, they are likely to replace chemical surfactants. The book focuses on biosurfactant production from various bacteria, diversity of biosurfactant producing bacteria, and the industrial need of biosurfactants. Fields such as pharmacy, medicine, and cosmetics are covered. It is presented in an easy-to-understand manner, and is well illustrated, and comprises protocols and recent data on the production, formulation and commercialization and other aspects of biosurfactants and bioemulsifiers.
Author: Feroz Jameel
Publisher: Springer
ISBN: 1493923161
Category : Medical
Languages : en
Pages : 710
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Book Description
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.
Author: Thomas Seak Hou Leong
Publisher: Springer
ISBN: 3319734911
Category : Science
Languages : en
Pages : 46
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Book Description
This SpringerBrief provides an overview of ultrasonic emulsification and an update on recent advances in developing stable emulsions for the creation of novel drugs and functional foods, with a focus on bioactive delivery in these products. Emulsification is the process of combining two or more immiscible liquids to form a semi-stable mixture. These two liquids generally consist of an organic (oil) phase and an aqueous (water) phase that is stabilized by the addition of an emulsifier. Most common emulsions are of the oil-in-water (O/W) type, but can also be of water-in-oil (W/O) or even multiple emulsion types (i.e. double emulsions) in the form of water-in-oil-in-water (W/O/W) or oil-in-water-in-oil (O/W/O) phases. The formation of an emulsion requires input of energy to distribute the disperse phase in the continuous phase in small-sized droplets that are able to resist instability. There is great interest in the use of ultrasound to produce emulsions, as it is able to do so relatively efficiently and effectively compared to existing techniques such as rotor stator, high-pressure homogenization and microfluidization. The interaction of ultrasound with the hydrocolloids and biopolymers that are often used to stabilize emulsions can offer advantages such as improved stability or greater control of formed droplet size distributions.
Author: Uri Zoller
Publisher: CRC Press
ISBN: 1439832951
Category : Science
Languages : en
Pages : 4002
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Book Description
With contributions from experts and pioneers, this set provides readers with the tools they need to answer the need for sustainable development faced by the industry. The six volumes constitute a shift from the traditional, mostly theoretical focus of most resources to the practical application of advances in research and development. With con
Author: Feroz Jameel
Publisher: John Wiley & Sons
ISBN: 0470118121
Category : Science
Languages : en
Pages : 978
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Book Description
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.
Author: Feroz Jameel
Publisher: Springer Nature
ISBN: 3030314154
Category : Medical
Languages : en
Pages : 888
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Book Description
The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide “one stop shopping” for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field.
