Biophysical Characterization Of Proteins In Developing Biopharmaceuticals
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Biophysical Characterization Of Proteins In Developing Biopharmaceuticals
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Author : Damian J. Houde
language : en
Publisher: Newnes
Release Date : 2014-09-05
Biophysical Characterization Of Proteins In Developing Biopharmaceuticals written by Damian J. Houde and has been published by Newnes this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-09-05 with Science categories.
Biophysical Characterization of Proteins in Developing Biopharmaceuticals is concerned with the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure this book takes the reader on a journey on how to best achieve this goal using the key relevant and practical methods commonly employed in the biopharmaceutical industry today as well as up and coming promising methods that are now gaining increasing attention. As a general resource guide this book has been written with the intent to help today's industrial scientists working in the biopharmaceutical industry or the scientists of tomorrow who are planning a career in this industry on how to successfully implement these biophysical methodologies. In so doing a keen focus is placed on understanding the capability of these methodologies in terms of what information they can deliver. Aspects of how to best acquire this biophysical information on these very complex drug molecules, while avoiding potential pitfalls, in order to make concise, well informed productive decisions about their development are key points that are also covered. - Presents the reader with a clear understanding of the real world issues and challenges in using these methods. - Highlights the capabilities and limitations of each method. - Discusses how to best analyze the data generated from these methods. - Points out what one needs to look for to avoid making faulty conclusions and mistakes. - In total it provides a check list or road map that empowers the industrial scientists as to what they need to be concerned with in order to effectively do their part in successfully developing these new drugs in an efficient and cost effective manner.
Biophysical Characterization Of Proteins In Developing Biopharmaceuticals
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Author : Damian J. Houde
language : en
Publisher: Elsevier
Release Date : 2019-11-13
Biophysical Characterization Of Proteins In Developing Biopharmaceuticals written by Damian J. Houde and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-11-13 with Medical categories.
Biophysical Characterization of Proteins in Developing Biopharmaceuticals, Second Edition, presents the latest on the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure, this book explains the best way to achieve this goal using key methods commonly employed in the biopharmaceutical industry. This book will help today's industrial scientists plan a career in this industry and successfully implement these biophysical methodologies. This updated edition has been fully revised, with new chapters focusing on the use of chromatography and electrophoresis and the biophysical characterization of very large biopharmaceuticals. In addition, best practices of applying statistical analysis to biophysical characterization data is included, along with practical issues associated with the concept of a biopharmaceutical's developability and the technical decision-making process needed when dealing with biophysical characterization data. - Presents basic protein characterization methods and tools applicable to (bio)pharmaceutical research and development - Highlights the capabilities and limitations of each technique - Discusses the underlining science of each tool - Empowers industrial biophysical chemists by providing a roadmap for applying biophysical tools - Outlines the needs for new characterization and analytical tools in the biopharmaceutical industry
Biosimilar Drug Product Development
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Author : Laszlo Endrenyi
language : en
Publisher: CRC Press
Release Date : 2017-02-24
Biosimilar Drug Product Development written by Laszlo Endrenyi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-02-24 with Medical categories.
When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.
Formulation And Process Development Strategies For Manufacturing Biopharmaceuticals
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Author : Feroz Jameel
language : en
Publisher: John Wiley & Sons
Release Date : 2010-08-09
Formulation And Process Development Strategies For Manufacturing Biopharmaceuticals written by Feroz Jameel 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 2010-08-09 with Science categories.
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.
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.
Hydrogen Exchange Mass Spectrometry Of Proteins
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Author : David D. Weis
language : en
Publisher: John Wiley & Sons
Release Date : 2016-01-12
Hydrogen Exchange Mass Spectrometry Of Proteins written by David D. Weis 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 2016-01-12 with Science categories.
Hydrogen exchange mass spectrometry is widely recognized for its ability to probe the structure and dynamics of proteins. The application of this technique is becoming widespread due to its versatility for providing structural information about challenging biological macromolecules such as antibodies, flexible proteins and glycoproteins. Although the technique has been around for 25 years, this is the first definitive book devoted entirely to the topic. Hydrogen Exchange Mass Spectrometry of Proteins: Fundamentals, Methods and Applications brings into one comprehensive volume the theory, instrumentation and applications of Hydrogen Exchange Mass Spectrometry (HX-MS) - a technique relevant to bioanalytical chemistry, protein science and pharmaceuticals. The book provides a solid foundation in the basics of the technique and data interpretation to inform readers of current research in the method, and provides illustrative examples of its use in bio- and pharmaceutical chemistry and biophysics In-depth chapters on the fundamental theory of hydrogen exchange, and tutorial chapters on measurement and data analysis provide the essential background for those ready to adopt HX-MS. Expert users may advance their current understanding through chapters on methods including membrane protein analysis, alternative proteases, millisecond hydrogen exchange, top-down mass spectrometry, histidine exchange and method validation. All readers can explore the diversity of HX-MS applications in areas such as ligand binding, membrane proteins, drug discovery, therapeutic protein formulation, biocomparability, and intrinsically disordered proteins.
Dispersity Structure And Phase Changes Of Proteins And Bio Agglomerates In Biotechnological Processes
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Author : Arno Kwade
language : en
Publisher: Springer Nature
Release Date : 2024-09-26
Dispersity Structure And Phase Changes Of Proteins And Bio Agglomerates In Biotechnological Processes written by Arno Kwade and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-09-26 with Science categories.
This book serves as a comprehensive summary of the priority program SPP 1934, which focused on understanding the dispersity, structure, and phase changes of proteins and bio-agglomerates in biotechnological processes. Through contributions from various research groups, the program explored how sensitive proteins and bio-agglomerates are affected by the process environment during fermentation, downstream processing, and formulation. It investigated these effects across three size scales: microscale, encompassing single proteins, clusters, crystals, and virus-like particles; mesoscale, focusing on cells and cell clusters; and macroscale, examining overall process dynamics. The main objective was to enhance biotechnological process chains by elucidating the mechanical, thermal, and chemical stresses that impact protein and bio-agglomerate structures. By gaining insights into these stressors, the program aimed to enable precise control measures to mitigate denaturation and unfavorable growth of proteins and cells. This compilation seeks to contribute to the optimization of biotechnological processes, facilitating advancements in various industries.
Analytical Characterization Of Biotherapeutics
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Author : Jennie R. Lill
language : en
Publisher: John Wiley & Sons
Release Date : 2017-07-10
Analytical Characterization Of Biotherapeutics written by Jennie R. Lill 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 2017-07-10 with Science categories.
The definitive guide to the myriad analytical techniques available to scientists involved in biotherapeutics research Analytical Characterization of Biotherapeutics covers all current and emerging analytical tools and techniques used for the characterization of therapeutic proteins and antigen reagents. From basic recombinant antigen and antibody characterization, to complex analyses for increasingly complex molecular designs, the book explores the history of the analysis techniques and offers valuable insights into the most important emerging analytical solutions. In addition, it frames critical questions warranting attention in the design and delivery of a therapeutic protein, exposes analytical challenges that may occur when characterizing these molecules, and presents a number of tested solutions. The first single-volume guide of its kind, Analytical Characterization of Biotherapeutics brings together contributions from scientists at the leading edge of biotherapeutics research and manufacturing. Key topics covered in-depth include the structural characterization of recombinant proteins and antibodies, antibody de novo sequencing, characterization of antibody drug conjugates, characterization of bi-specific or other hybrid molecules, characterization of manufacturing host-cell contaminant proteins, analytical tools for biologics molecular assessment, and more. Each chapter is written by a recognized expert or experts in their field who discuss current and cutting edge approaches to fully characterizing biotherapeutic proteins and antigen reagents Covers the full range of characterization strategies for large molecule based therapeutics Provides an up-to-date account of the latest approaches used for large molecule characterization Chapters cover the background needed to understand the challenges at hand, solutions to characterize these large molecules, and a summary of emerging options for analytical characterization Analytical Characterization of Biotherapeutics is an up-to-date resource for analytical scientists, biologists, and mass spectrometrists involved in the analysis of biomolecules, as well as scientists employed in the pharmaceuticals and biotechnology industries. Graduate students in biology and analytical science, and their instructors will find it to be fascinating and instructive supplementary reading.
Advances In Root Vegetables Research
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Author : Prashant Kaushik
language : en
Publisher: BoD – Books on Demand
Release Date : 2023-02-15
Advances In Root Vegetables Research written by Prashant Kaushik and has been published by BoD – Books on Demand this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-02-15 with Gardening categories.
Root vegetables are the sections of underground plants that are harvested and consumed by humans for their nutritional value. They are found in a wide variety of plant species. Even though botany draws a distinction between real roots and non-roots, the term “root vegetable” refers to both kinds in the context of agriculture and cuisine, despite botany classifying genuine roots as separate from non-roots. Root vegetables are often storage organs that store energy in the form of carbohydrates. This book explores recent developments in root vegetable research against the background of current and impending environmental change.
The Hidden World Of Protein Aggregation
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Author :
language : en
Publisher: Elsevier
Release Date : 2024-05-30
The Hidden World Of Protein Aggregation written by and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-05-30 with Science categories.
The Hidden World of Protein Aggregation, Volume 206 provides a comprehensive exploration of protein aggregation, uncovering the factors behind the formation of amorphous aggregates and ordered structures called amyloid fibrils. It delves into the advantages and disadvantages of protein aggregates, addressing topics such as cytotoxicity and disorders linked to misfolding. Specific chapters in this release include Protein Aggregation: An Overview, Pathways of Amyloid Fibril Formation and Aggregation, Factors Influencing Amyloid Fibril Formation, Morphological Features and Types of Aggregated Structures, Each big journey starts with a first step: Importance of Oligomerization, Liquid-Liquid Phase Separation as Triggering Factor of Fibril Formation, and more.Additional sections cover Experimental Techniques for Detecting and Evaluating the Amyloid Fibrils, Prediction of Protein Aggregation, Amyloid Fibril Cytotoxicity and Associated Disorders, Inhibitors of Amyloid Fibril Formation, Therapeutic Approaches in Proteinopathies, Functional Amyloids, Biotechnological Applications of Amyloid Fibrils, and The Hidden World of Protein Aggregation. - Provides an introduction to the folding of protein and associated conditions leading to aggregation and linked pathology - Discusses structural biology and computational methodologies for analysis of protein (mis)folding and aggregation - Describes functional amyloids and their biotechnological applications