Protein Instability At Interfaces During Drug Product Development
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Protein Instability At Interfaces During Drug Product Development
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Author : Jinjiang Li
language : en
Publisher: Springer Nature
Release Date : 2021-02-12
Protein Instability At Interfaces During Drug Product Development written by Jinjiang Li and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-02-12 with Medical categories.
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.
Challenges In Protein Product Development
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Author : Nicholas W. Warne
language : en
Publisher: Springer
Release Date : 2018-06-20
Challenges In Protein Product Development written by Nicholas W. Warne and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-06-20 with Medical categories.
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.
Protein Formulation And Delivery
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Author : Eugene J. McNally
language : en
Publisher: CRC Press
Release Date : 2007-10-26
Protein Formulation And Delivery written by Eugene J. McNally and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-10-26 with Medical categories.
This title is intended to assist pharmaceutical scientists in the development of stable protein formulations during the early stages of the product development process, providing a comprehensive review of mechanisms and causes of protein instability in formulation development, coverage of accelerated stability testing methods and relevant analytica
Surfactants In Biopharmaceutical Development
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Author : Atanas V. Koulov
language : en
Publisher: Academic Press
Release Date : 2023-08-25
Surfactants In Biopharmaceutical Development written by Atanas V. Koulov and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-08-25 with Medical categories.
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
Rational Design Of Stable Protein Formulations
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Author : John F. Carpenter
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06
Rational Design Of Stable Protein Formulations written by John F. Carpenter and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-06 with Medical categories.
Recombinant proteins and polypeptides continue to be the most important class of biotechnology-derived agents in today's pharmaceutical industry. Over the past few years, our fundamental understanding of how proteins degrade and how stabilizing agents work has made it possible to approach formulation of protein pharmaceuticals from a much more rational point of view. This book describes the current level of understanding of protein instability and the strategies for stabilizing proteins under a variety of stressful conditions.
The Development Of Novel Excipients For The Stabilization Of Proteins Against Aggregation
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Author : Curtiss Paul Schneider
language : en
Publisher:
Release Date : 2011
The Development Of Novel Excipients For The Stabilization Of Proteins Against Aggregation written by Curtiss Paul Schneider and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011 with categories.
Although protein based therapeutics is the fastest growing sector of the pharmaceutical industry, production costs remain incredibly high and rapid commercialization of new protein drug candidates are not being fully realized due to the presence of many barriers, namely the physical and chemical instabilities of proteins. Of these degradation pathways, protein aggregation is arguably the most common and troubling manifestation of protein instability, occurring in almost all phases of development. Protein aggregates are usually nonnative in structure, may exhibit reduced biological activity, and can remain soluble and/or precipitate from solution. In addition to reducing efficacy, if administered to a patient, aggregates can cause adverse reactions, such as immune response, sensitization, or even anaphylactic shock. Therefore, if even a small amount of aggregates form during formulation or storage, a product can be rendered unacceptable. Moreover, for the practical application of traditional and novel drug delivery techniques, protein based therapeutics must be formulated at relatively high concentrations and must remain stable for extended periods of time. The structural differences among various proteins are so significant, that the application of a universal stabilization strategy has not yet been successful, though the effects of common excipients are generally universal. The current approach toward stabilizing protein drugs against aggregation is by trial-and-error testing of different combinations of cosolutes (e.g. salts, sugars, surfactants, amino acids, etc.) using empirically derived heuristics. While ubiquitously used, this approach is inefficient and does not always enable the discovery of stable protein solution formulations. In response to this major problem, we have developed and tested a new class of excipients that has the potential for wide spread application as a universal stabilizer of protein therapeutics. When compared to other commonly used excipients, our novel excipients offer more than an order of magnitude improvement at suppressing the aggregation of a model protein. As a result, if used in formulations, the shelf life of a protein drug, at room or refrigerated temperatures, may be extended from a few weeks to several months or years. Furthermore, these excipients will likely be useful during production and purification for improving yield and lowering downstream purification costs.
Disruption Of Protein Protein Interfaces
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Author : Stefano Mangani
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-06-28
Disruption Of Protein Protein Interfaces written by Stefano Mangani and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-06-28 with Science categories.
"Disruption of Protein-Protein Interfaces" reviews the latest developments and future perspectives in drug discovery at protein-protein interfaces. The authors detail experimental and computational tools to tackle the subject and highlight the contribution of the Italian research community to the field. Evidence shows that blocking or modulating protein-protein interactions might lead to the development of useful new drugs. Consequently, in recent years great effort has been dedicated to unveiling the molecular details of protein-protein interfaces by structural techniques e.g. X-ray diffraction, NMR spectroscopy. This book, written and edited by leaders in the field, provides examples from the literature of successes and failures to develop drug-like molecules effective in interacting at protein-protein interfaces.
Aggregation Of Therapeutic Proteins
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Author : Wei Wang
language : en
Publisher: John Wiley & Sons
Release Date : 2010-12-28
Aggregation Of Therapeutic Proteins written by Wei Wang and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-12-28 with Medical categories.
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.
Stability And Characterization Of Protein And Peptide Drugs
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Author : Rodney Pearlman
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-06-29
Stability And Characterization Of Protein And Peptide Drugs written by Rodney Pearlman and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-06-29 with Medical categories.
This is the first volume to make available specific case histories of therapeutic proteins and peptides that have been marketed or are currently under clinical testing. The editors have selected a wide range of molecules derived from monoclonal antibodies, recombinant DNA, and natural and chemical sources to provide formulation scientists with practical examples of the development of pharmaceutical products.
Pharmaceutical Formulation Development Of Peptides And Proteins
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Author :
language : en
Publisher:
Release Date : 2000
Pharmaceutical Formulation Development Of Peptides And Proteins written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000 with Peptide drugs categories.