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Biophysical Characterization of Proteins in Developing Biopharmaceuticals

Biophysical Characterization of Proteins in Developing Biopharmaceuticals
  • Author : Damian J. Houde,Steven A. Berkowitz
  • Publisher :Unknown
  • Release Date :2019-11-13
  • Total pages :586
  • ISBN : 9780444641748
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Summary : 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

Biosimilar Drug Product Development
  • Author : Laszlo Endrenyi,Dr. Paul Declerck,Shein-Chung Chow
  • Publisher :Unknown
  • Release Date :2017-02-24
  • Total pages :477
  • ISBN : 9781351646185
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Summary : 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.

Biophysics for Therapeutic Protein Development

Biophysics for Therapeutic Protein Development
  • Author : Linda O. Narhi
  • Publisher :Unknown
  • Release Date :2013-02-26
  • Total pages :293
  • ISBN : 9781461443162
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Summary : This book can be used to provide insight into this important application of biophysics for those who are planning a career in protein therapeutic development, and for those outside this area who are interested in understanding it better. The initial chapters describe the underlying theory, and strengths and weaknesses of the different techniques commonly used during therapeutic development. The majority of the chapters discuss the applications of these techniques, including case studies, across the product lifecycle from early discovery, where the focus is on identifying targets, and screening for potential drug product candidates, through expression and purification, large scale production, formulation development, lot-to-lot comparability studies, and commercial support including investigations.

Hydrogen Exchange Mass Spectrometry of Proteins

Hydrogen Exchange Mass Spectrometry of Proteins
  • Author : David D. Weis
  • Publisher :Unknown
  • Release Date :2016-01-12
  • Total pages :376
  • ISBN : 9781118703731
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Summary : 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.

Development of Biopharmaceutical Drug-Device Products

Development of Biopharmaceutical Drug-Device Products
  • Author : Feroz Jameel,John W. Skoug,Robert R. Nesbitt
  • Publisher :Unknown
  • Release Date :2020-03-13
  • Total pages :893
  • ISBN : 9783030314156
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Summary : 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.

Biophysical Methods for Biotherapeutics

Biophysical Methods for Biotherapeutics
  • Author : Tapan K. Das
  • Publisher :Unknown
  • Release Date :2014-04-28
  • Total pages :376
  • ISBN : 9780470938430
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Summary : With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development. • Helps formulation and analytical scientists in pharma and biotech better understand and use biophysical methods • Chapters organized according to the sequential nature of the drug development process • Helps formulation, analytical, and bioanalytical scientists in pharma and biotech better understand and usestrengths and limitations of biophysical methods • Explains how to use biophysical methods, the information obtained, and what needs to be presented in a regulatory filing, assess impact on quality and immunogenicity • With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
  • Author : Feroz Jameel,Susan Hershenson
  • Publisher :Unknown
  • Release Date :2010-07-13
  • Total pages :976
  • ISBN : 9780470595879
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Summary : 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.

Biotechnology and Biopharmaceuticals

Biotechnology and Biopharmaceuticals
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :2013-12-16
  • Total pages :744
  • ISBN : 9781118179796
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Summary : Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.

Biophysical Methods for Biotherapeutics

Biophysical Methods for Biotherapeutics
  • Author : Tapan K. Das
  • Publisher :Unknown
  • Release Date :2014-02-27
  • Total pages :376
  • ISBN : 9781118354681
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Summary : With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development. • Helps formulation and analytical scientists in pharma and biotech better understand and use biophysical methods • Chapters organized according to the sequential nature of the drug development process • Helps formulation, analytical, and bioanalytical scientists in pharma and biotech better understand and usestrengths and limitations of biophysical methods • Explains how to use biophysical methods, the information obtained, and what needs to be presented in a regulatory filing, assess impact on quality and immunogenicity • With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development.

State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization

State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization
  • Author : Oleg Borisov
  • Publisher :Unknown
  • Release Date :2014
  • Total pages :229
  • ISBN : 0841230269
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Summary :

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
  • Author : Feroz Jameel,Susan Hershenson
  • Publisher :Unknown
  • Release Date :2010-07-13
  • Total pages :976
  • ISBN : 9780470595879
GET BOOK HERE

Summary : 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.

Formulation, Characterization, and Stability of Protein Drugs

Formulation, Characterization, and Stability of Protein Drugs
  • Author : Rodney Pearlman,Y. John Wang
  • Publisher :Unknown
  • Release Date :2006-04-11
  • Total pages :432
  • ISBN : 9780306474521
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Summary : Leading scientists offer detailed profiles of ten protein drugs currently in development. The case histories of these important new compounds are described from the perspective of their formulation, characterization, and stability. This ready reference also features recent data and an abundance of previously unpublished information. The in-depth coverage includes a highly useful compendium of degradation sites occurring in over 70 proteins. An invaluable aid in the rapid identification of potential `hot spots' in proteins, this accessible compilation allows for inspection of the protein's primary structure and preparation of a hydroflex plot.

Human Cytosolic Sulfotransferases

Human Cytosolic Sulfotransferases
  • Author : Gian Maria Pacifici,Michael W. H. Coughtrie
  • Publisher :Unknown
  • Release Date :2019-08-30
  • Total pages :336
  • ISBN : 0367392569
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Summary : The existence of multiple sulfotransferases (SULTS) was first discovered in 1958. Since then, any attempts to create a comprehensive text dedicated to sulfation and sulfotransferases have been rare and, thanks to rapid advances in molecular biology and biochemistry, quickly outdated. However, those advances have permitted an accelerated understanding of human sulfotransferase activity and with it the creation of a growing database on sulfotransferases that, until now, has remained scattered in the literature. Human Cytosolic Sulfotransferases serves an important function by the mere feat of culling the information from the literature to present an up-to-date summary of the field. Fortunately, the editors have gone a step further in providing us with a multidisciplinary overview of human sulfotransferases, covering not only basic biochemistry, genetics, and molecular biology, but also exploring current clinical uses involving pharmacology, enzymology, and environmental toxicology. The book's thirteen chapters, written by some of the most renowned scientists in the field, address the huge diversity of topics that are impacted by sulfation. Included are discussions that move from general nomenclature and structure to molecular cloning of human cytosolic sulfotransferases, and sulfate conjugation in pharmocogenetics and pharmacogenomics. Entire chapters focus on sulfotransferases in the human fetus and neonate, sulfation of thyroid hormones, as well as estrogen sulfotransferases in breast cancer and the activation/inactivation of carcinogens and mutagens by human sulfotransferases.

Biosimilars

Biosimilars
  • Author : Hiten J. Gutka,Harry Yang,Shefali Kakar
  • Publisher :Unknown
  • Release Date :2018-12-13
  • Total pages :709
  • ISBN : 9783319996806
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Summary : This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.

Aggregation of Therapeutic Proteins

Aggregation of Therapeutic Proteins
  • Author : Wei Wang,Christopher J. Roberts
  • Publisher :Unknown
  • Release Date :2010-12-28
  • Total pages :484
  • ISBN : 1118043588
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Summary : 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.

Characterization of Protein Therapeutics using Mass Spectrometry

Characterization of Protein Therapeutics using Mass Spectrometry
  • Author : Guodong Chen
  • Publisher :Unknown
  • Release Date :2014-07-08
  • Total pages :404
  • ISBN : 9781441978622
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Summary : This book highlights current approaches and future trends in the use of mass spectrometry to characterize protein therapies. As one of the most frequently utilized analytical techniques in pharmaceutical research and development, mass spectrometry has been widely used in the characterization of protein therapeutics due to its analytical sensitivity, selectivity, and specificity. This book begins with an overview of mass spectrometry techniques as related to the analysis of protein therapeutics, structural identification strategies, quantitative approaches, followed by studies involving characterization of process related protein drug impurities/degradants, metabolites, higher order structures of protein therapeutics. Both general practitioners in pharmaceutical research and specialists in analytical sciences will benefit from this book that details step-by-step approaches and new strategies to solve challenging problems related to protein therapeutics research and development.

Mass Spectrometry in Structural Biology and Biophysics

Mass Spectrometry in Structural Biology and Biophysics
  • Author : Igor A. Kaltashov,Stephen J. Eyles
  • Publisher :Unknown
  • Release Date :2012-04-03
  • Total pages :289
  • ISBN : 9780470937792
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Summary : With its detailed and systematic coverage of the current state of biophysical mass spectrometry (MS), here is one of the first systematic presentations of the full experimental array of MS-based techniques used in biophysics, covering both fundamental and practical issues. The book presents a discussion of general biophysical concepts and a brief overview of traditional biophysical techniques before outlining the more advanced concepts of mass spectrometry. The new edition gives an up-to-date and expanded coverage of experimental methodologies and a clear look at MS-based methods for studying higher order structures and biopolymers. A must for researchers in the field of biophysics, structural biology, and protein chemistry.

Analytical Characterization of Biotherapeutics

Analytical Characterization of Biotherapeutics
  • Author : Jennie R. Lill,Wendy Sandoval
  • Publisher :Unknown
  • Release Date :2017-08-14
  • Total pages :368
  • ISBN : 9781119053101
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Summary : 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.

Delivery Technologies for Biopharmaceuticals

Delivery Technologies for Biopharmaceuticals
  • Author : Lene Jorgensen,Hanne Morck Nielson
  • Publisher :Unknown
  • Release Date :2009-10-23
  • Total pages :442
  • ISBN : 9780470688403
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Summary : Advances in biotechnology have provided scientists with an increasing number of biopharmaceuticals such as novel peptide and protein drugs as well as nucleic acid based drugs for gene therapy. However, successful delivery of these biopharmaceuticals is a major challenge because their molecular properties lead to poor physical and chemical stability in the body and limited membrane permeability. Therefore researchers are developing a range of new delivery technologies and materials to enable these new drugs to be delivered intact to their target sites. Delivery Technologies for Biopharmaceuticals describes strategies to overcome the main barriers for successful delivery of therapeutic peptides, proteins, and nucleic acid-based drugs or vaccines related to the site of administration and the target site. Many of the approaches described are reported in formulations in current clinical trials as well as in marketed products. Contents include: challenges in delivery of biopharmaceuticals novel formulation approaches for peptide and protein injectables non-viral chemical vectors and viral technology for delivery of nucleic acid based drugs immune response, adjuvants and delivery systems for vaccines several examples of delivery systems for different biopharmaceuticals a critical assessment of delivery technologies for biopharmaceuticals Delivery Technologies for Biopharmaceuticals is an essential single-volume introduction to the technologies used by researchers to ensure efficient delivery of this exciting new class of drugs. It will be of value to researchers and students working in drug delivery, formulation, biopharmaceuticals, medicinal chemistry, and new materials development.

Biopharmaceutical Production Technology

Biopharmaceutical Production Technology
  • Author : Ganapathy Subramanian
  • Publisher :Unknown
  • Release Date :2012-05-14
  • Total pages :944
  • ISBN : 9783527653119
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Summary : Cost-effective manufacturing of biopharmaceutical products is rapidly gaining in importance, while healthcare systems across the globe are looking to contain costs and improve efficiency. To adapt to these changes, industries need to review and streamline their manufacturing processes. This two volume handbook systematically addresses the key steps and challenges in the production process and provides valuable information for medium to large scale producers of biopharmaceuticals. It is divided into seven major parts: - Upstream Technologies - Protein Recovery - Advances in Process Development - Analytical Technologies - Quality Control - Process Design and Management - Changing Face of Processing With contributions by around 40 experts from academia as well as small and large biopharmaceutical companies, this unique handbook is full of first-hand knowledge on how to produce biopharmaceuticals in a cost-effective and quality-controlled manner.

Therapeutic Proteins

Therapeutic Proteins
  • Author : C. Mark Smales,David Cameron James
  • Publisher :Unknown
  • Release Date :2005
  • Total pages :482
  • ISBN : 9781592599226
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Summary : This volume contains contributions from leaders in the field of therapeutic protein expression, purification, characterization, formulation and viral inactivation who cover all aspects of protein drug production downstream of the discovery stage. Protocols for the production of therapeutic proteins using a variety of sources are covered. including bacterial and yeast expression systems, insect and mammalian cells. Therapeutic Proteins: Methods and Protocols will prove an invaluable resourse to all those working in the field of therapeutic protein production.