Fast Dynamic Surfactant Reduces Aggregation Of Biologics PDF Download
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Author | : Joshua S Katz |
Publisher | : |
Total Pages | : |
Release | : 2017 |
Genre | : |
ISBN | : |
Download Fast Dynamic Surfactant Reduces Aggregation of Biologics Book in PDF, ePub and Kindle
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.
Author | : Jinjiang Li |
Publisher | : Springer Nature |
Total Pages | : 338 |
Release | : 2021-02-12 |
Genre | : Medical |
ISBN | : 3030571777 |
Download Protein Instability at Interfaces During Drug Product Development Book in PDF, ePub and Kindle
Proteins are exposed to various interfacial stresses during drug product development. They are subjected to air-liquid, liquid-solid, and, sometimes, liquid-liquid interfaces throughout the development cycle-from manufacturing of drug substances to storage and drug delivery. Unlike small molecule drugs, proteins are typically unstable at interfaces where, on adsorption, they often denature and form aggregates, resulting in loss of efficacy and potential immunogenicity. This book covers both the fundamental aspects of proteins at interfaces and the quantification of interfacial behaviors of proteins. Importantly, this book introduces the industrial aspects of protein instabilities at interfaces, including the processes that introduce new interfaces, evaluation of interfacial instabilities, and mitigation strategies. The audience that this book targets encompasses scientists in the pharmaceutical and biotech industry, as well as faculty and students from academia in the surface science, pharmaceutical, and medicinal chemistry areas.
Author | : Jennifer J. McManus |
Publisher | : Humana |
Total Pages | : 266 |
Release | : 2020-08-08 |
Genre | : Science |
ISBN | : 9781493996803 |
Download Protein Self-Assembly Book in PDF, ePub and Kindle
This volume explores experimental and computational approaches to measuring the most widely studied protein assemblies, including condensed liquid phases, aggregates, and crystals. The chapters in this book are organized into three parts: Part One looks at the techniques used to measure protein-protein interactions and equilibrium protein phases in dilute and concentrated protein solutions; Part Two describes methods to measure kinetics of aggregation and to characterize the assembled state; and Part Three details several different computational approaches that are currently used to help researchers understand protein self-assembly. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Thorough and cutting-edge, Protein Self-Assembly: Methods and Protocols is a valuable resource for researchers who are interested in learning more about this developing field.
Author | : Ranga Narayanan |
Publisher | : Springer |
Total Pages | : 267 |
Release | : 2008-08-28 |
Genre | : Technology & Engineering |
ISBN | : 3540698108 |
Download Interfacial Processes and Molecular Aggregation of Surfactants Book in PDF, ePub and Kindle
Given the enormous interest in surface phenomena in areas ranging from materials science to applications in life science, this volume is a very timely addition to the literature. Emphasis is on surfactants mediating interfacial and molecular aggregation phenomena, and the following topics are reviewed in particular: dissolution rates, equilibrium adsorption, mixing rules, and spreading on a solid surface of surfactants, as well as the role of surfactants in mediating a range of processes, such as the fabrication of various nanomaterials. Written and edited by leading experts, this volume is dedicated to Professor Dinesh O. Shah, one of the pioneers in this field.
Author | : Feroz Jameel |
Publisher | : Springer Nature |
Total Pages | : 888 |
Release | : 2020-03-13 |
Genre | : Medical |
ISBN | : 3030314154 |
Download Development of Biopharmaceutical Drug-Device Products Book in PDF, ePub and Kindle
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.
Author | : Nikhil R Jana |
Publisher | : CRC Press |
Total Pages | : 112 |
Release | : 2019-03-26 |
Genre | : Medical |
ISBN | : 0429524234 |
Download Colloidal Nanoparticles Book in PDF, ePub and Kindle
This book will focus on synthesis, coating and functionalization chemistry of selected nanoparticles that are most commonly used in various biomedical applications. Apart from standard selected chemical synthetic methods, it focusses on design consideration of functionalization, selected coating chemistry for transforming as synthesized nanoparticle, selected conjugation chemistries and purification approach for such nanoparticles. It also includes state-of-art/future prospect of nanodrugs suitable for clinical applications. There will material on general application potential of these nanoparticles, importance of functionalization and common problems faced by non-chemists.
Author | : Tharwat Tadros |
Publisher | : Springer |
Total Pages | : 0 |
Release | : 2013-06-28 |
Genre | : Technology & Engineering |
ISBN | : 9783642206641 |
Download Encyclopedia of Colloid and Interface Science Book in PDF, ePub and Kindle
An authoritative and comprehensive reference relevant to all scientists and engineers in the field. This encyclopedia not only helps chemistry, materials science and physics researchers to understand the principles, but also provides practicing engineers with the necessary information for implementing practical applications, such as Food and agrochemicals Polymers and ceramics Cosmetics and detergents Paints and coatings Pharmaceuticals and drug delivery In addition, the encyclopedia is an important reference for industrial chemists and chemical engineers faced with a multitude of industrial systems of a colloidal nature. As wide as the range of applications that colloid and interface science has is the range of scientific disciplines that contribute to research and development in this field. These encompass chemistry, physics, biology and mathematics as well as nanoscience and nanotechnology. The encyclopedia provides easy-to-digest information for meeting these interdisciplinary challenges. While providing numerous concise definitions of key terms, the encyclopedia also features more than forty in-depth essays on topics ranging from Agrochemical Formulations to Zeta Potential. All entries are cross-referenced and include selected references to original literature as well as synonyms.
Author | : E. Wyn-Jones |
Publisher | : Springer Science & Business Media |
Total Pages | : 504 |
Release | : 2012-12-06 |
Genre | : Science |
ISBN | : 9401018553 |
Download Chemical and Biological Applications of Relaxation Spectrometry Book in PDF, ePub and Kindle
Chemical relaxation spectrometry involves the application of several different relaxation techniques to investigate the kinetics and mechanisms of fast chemical reactions and also dynamic molecul 10 ar processes that occur in liquids in the time range 1 - 10- secs. These methods have been used widely in several disciplines of the natural sciences including molecular biology, biochemistry, organic stereochemistry, detergent chemistry and inorganic chemistry. The purpose of the Advanced Study Institute was to provide a forum for scientists to discuss the role, scope and limitations of the various applications of chemical relaxation methods in order to stimulate discussion and interaction between workers in these different fields. The papers described in this volume are a summary of the contributions that were discussed at the meeting. The brief given to the authors was to attempt to prepare an article contain ing a good supply of references so that the book can be used not only by those starting in the field, but also by the specialist and research worker. These contributions cover a varied range of topics summarizing the achievements, the current state of knowledge and possible application in many disciplines. It is to be hoped that this volume will help to point out some new directions towards which research efforts are required and to attract new researchers with fresh points of view.
Author | : Raoul Zana |
Publisher | : CRC Press |
Total Pages | : 345 |
Release | : 2003-10-07 |
Genre | : Science |
ISBN | : 0824757041 |
Download Gemini Surfactants Book in PDF, ePub and Kindle
Generating much interest in both academic and scientific circles, Gemini Surfactants gathers the most up-to-date research in gemini surfactantproduction and demonstrates how their propertiesand performance can revolutionize the current industrial application of these surfactants. It surveys the state of special gemini surfactants, including nonionic, zwitterionic, fluorinated, and amino-acid-based surfactants. Gemini Surfactants considers the synthesis, phase behavior, and rheology of gemini and related surfactants and clarifies the adsorption and surface tension behavior of gemini surfactants at air–water, oil–water, and solid–water interfaces. The book also details the physicochemical properties and microstructure of aqueous micellar solutions of gemini surfactants and describes mixed micellization between gemini surfactants and conventional surfactants.
Author | : Wei Wang |
Publisher | : John Wiley & Sons |
Total Pages | : 400 |
Release | : 2010-12-28 |
Genre | : Medical |
ISBN | : 1118043588 |
Download Aggregation of Therapeutic Proteins Book in PDF, ePub and Kindle
This book gives pharmaceutical scientists an up-to-date resource on protein aggregation and its consequences, and available methods to control or slow down the aggregation process. While significant progress has been made in the past decade, the current understanding of protein aggregation and its consequences is still immature. Prevention or even moderate inhibition of protein aggregation has been mostly experimental. The knowledge in this book can greatly help pharmaceutical scientists in the development of therapeutic proteins, and also instigate further scientific investigations in this area. This book fills such a need by providing an overview on the causes, consequences, characterization, and control of the aggregation of therapeutic proteins.