Search results for: therapeutic-fc-fusion-proteins

Therapeutic Fc Fusion Proteins

Author : Steven M. Chamow
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Edited by three pioneers in the field, each with longstanding experience in the biotech industry, and a skilled scientific writer, this is the first book to cover every step in the development and production of immunoglobulin Fc-fusion proteins as therapeutics for human disease: from choosing the right molecular design, to pre-clinical characterization of the purified product, through to batch optimization and quality control for large-scale cGMP production. The whole of the second part is devoted to case studies of Fc-fusion proteins that are now commercially successful products. In this section, the authors, several of whom were personally involved in clinical development of the products themselves, detail the product?s background and give insight into issues that were faced and how these issues were overcome during clinical development. This section also includes a chapter on promising new developments for the future. An invaluable resource for professionals already working on Fc-fusion proteins and an excellent and thorough introduction for physicians, researchers, and students entering the field.

Fusion Protein Technologies for Biopharmaceuticals

Author : Stefan R. Schmidt
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The state of the art in biopharmaceutical FUSION PROTEINDESIGN Fusion proteins belong to the most lucrative biotechdrugs—with Enbrel® being one of the best-sellingbiologics worldwide. Enbrel® represents a milestone of moderntherapies just as Humulin®, the first therapeutic recombinantprotein for human use, approved by the FDA in 1982 andOrthoclone® the first monoclonal antibody reaching the marketin 1986. These first generation molecules were soon followed by aplethora of recombinant copies of natural human proteins, and in1998, the first de novo designed fusion protein was launched. Fusion Protein Technologies for Biopharmaceuticalsexamines the state of the art in developing fusion proteins forbiopharmaceuticals, shedding light on the immense potentialinherent in fusion protein design and functionality. A widepantheon of international scientists and researchers deliver acomprehensive and complete overview of therapeutic fusion proteins,combining the success stories of marketed drugs with the dynamicpreclinical and clinical research into novel drugs designed for asyet unmet medical needs. The book covers the major types of fusionproteins—receptor-traps, immunotoxins, Fc-fusions andpeptibodies—while also detailing the approaches fordeveloping, delivering, and improving the stability of fusionproteins. The main body of the book contains three large sectionsthat address issues key to this specialty: strategies for extendingthe plasma half life, the design of toxic proteins, and utilizingfusion proteins for ultra specific targeting. The book concludeswith novel concepts in this field, including examples of highlyrelevant multifunctional antibodies. Detailing the innovative science, commercial realities, andbrilliant potential of fusion protein therapeutics, FusionProtein Technologies for Biopharmaceuticals is a must forpharmaceutical scientists, biochemists, medicinal chemists,molecular biologists, pharmacologists, and genetic engineersinterested in determining the shape of innovation in the world ofbiopharmaceuticals.

Antibody Fc Engineering Towards Better Therapeutics

Author : Tianlei Ying
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Protein Therapeutics 2 Volume Set

Author : Tristan Vaughan
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In this practice-oriented two volume handbook, professionals from some of the largest biopharmaceutical companies and top academic researchers address the key concepts and challenges in the development of protein pharmaceuticals for medicinal chemists and drug developers of all trades. Following an introduction tracing the rapid development of the protein therapeutics market over the last decade, all currently used therapeutic protein scaffolds are surveyed, from human and non-human antibodies to antibody mimetics, bispecific antibodies and antibody-drug conjugates. This ready reference then goes on to review other key aspects such as pharmacokinetics, safety and immunogenicity, manufacture, formulation and delivery. The handbook then takes a look at current key clinical applications for protein therapeutics, from respiratory and inflammation to oncology and immune-oncology, infectious diseases and rescue therapy. Finally, several exciting prospects for the future of protein therapeutics are highlighted and discussed.

Monoclonal Antibodies

Author : Maher Albitar
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Monoclonal Antibodies: Methods and Protocols examines a collection of state-of-the-art methods that employ monoclonal antibodies in a clinical setting with opening chapters focusing on the gold standard method for generating mouse monoclonal antibodies through hybridoma technology, future methods for engineering recombinant and humanized antibodies, methods for engineering soluble Fc fusion protein, and the use of antibodies and flow cytometry in the quantification of cell signaling proteins. Specific chapters describe how antibodies are used for the diagnosis and classification of hematologic diseases. Subsequent chapters examine the advantages and most recent advances of using bead-based immunoassays, including the ability of bead-based technology to multiplex and analyze several analytes simultaneously, and the use of beads in detecting fusion proteins resulting from chromosomal translocations. Concluding chapters provide additional examples of methodologies that employ monoclonal antibodies.

Therapeutic Monoclonal Antibodies

Author : Zhiqiang An
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70-chapter authoritative reference that covers therapeutic monoclonal antibody discovery, development, and clinical applications while incorporating principles, experimental data, and methodologies. First book to address the discovery and development of antibody therapeutics in their entirety. Most chapters contain experimental data to illustrate the principles described in them. Authors provide detailed methodologies that readers can take away with them and use in their own laboratories.

Antibody Fusion Proteins

Author : Steven M. Chamow
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Thoroughly detailed and illustrated, this book examines the construction, properties, applications, and problems associated with specific types of fusion molecules used in clinical and research medicine. The editors present an overview of the field, followed by nine chapters divided into two general sections based on the two primary parts of the antibody molecule: Fab fusion proteins and Fc fusion proteins. In addition, numerous renowned scientists in the field have contributed outlines demonstrating man-made molecules that will be required not only to overcome the limitations of monoclonal antibodies, but also to extend the principle of selective targeting. Divided into specific, accessible sections, Antibody Fusion Proteins includes: * Chapters describing Fc fusion proteins, as well as several classes of antigen-binding proteins * Complete details on the design and molecular construction of genetically engineered fusion molecules * Useful information on molecular purification, large-scale production, practical applications, and their therapeutic potential * The latest data on forming fusion proteins with toxins, cytokines, or enzymes that can activate a prodrug

Therapeutic Proteins

Author : Roland Kontermann
File Size : 72.17 MB
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For this ready reference, the internationally renowned authority in the field, Roland Kontermann, has assembled a team of outstanding contributors from industry and academia to convey the worldwide knowledge on modifying therapeutic proteins in order to optimize their pharmacological potential. The result is a comprehensive work covering all approaches and aspects of the topic in one handy volume, making this indispensable reading for companies and research institutions working on the development of biopharmaceuticals.

Recombinant Factor VIII Fc Fusion Protein for Immune Tolerance Induction in Patients with Severe Haemophilia A Withinhibitors A Retrospective Analysis

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Abstract : Introduction: Immune tolerance induction (ITI) is the gold standard for eradication of factor VIII inhibitors in severe haemophilia A; however, it usually requires treatment for extended periods with associated high burden on patients and healthcare resources. Aim: Review outcomes of ITI with recombinant factor VIII Fc fusion protein (rFVIIIFc) in patients with severe haemophilia A and high‐titre inhibitors. Methods: Multicentre retrospective chart review of severe haemophilia A patients treated with rFVIIIFc for ITI. Results: Of 19 patients, 7 were first‐time ITI and 12 were rescue ITI. Of 7 first‐time patients, 6 had at least 1 high‐risk feature for ITI failure. Four of 7 first‐time patients were tolerized in a median of 7.8months. The remaining 3 patients continue on rFVIIIFc ITI. Of 12 rescue patients, 7 initially achieved a negative Bethesda titre (≤0.6) in a median of 3.3months, 1 had a decrease in Bethesda titre and continues on rFVIIIFc ITI and 4 have not demonstrated a decrease in Bethesda titre. Of these 4, 3 continue on rFVIIIFc ITI and 1 switched to bypass therapy alone. Two initially responsive patients transitioned to other factors due to recurrence. Overall, 16 of 19 patients remain on rFVIIIFc (prophylaxis or ITI). For those still undergoing ITI, longer follow‐up is needed to determine final outcomes. No adverse events reported. Conclusions: Recombinant factor VIII Fc fusion protein demonstrated rapid time to tolerization in high‐risk first‐time ITI patients. For rescue ITI, rFVIIIFc showed therapeutic benefit in some patients who previously failed ITI with other products. These findings highlight the need to further evaluate the use of rFVIIIFc for ITI.

New Drugs for Malignancy An Issue of Hematology Oncology Clinics of North America E Book

Author : Franco Muggia
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Topics include: Targeting IGF-1R, Tyrosine Kinase Inhibitors in Lung Cancer, Targeting mTOR, Targeting Hedgehog, Mitotic Inhibitors, Topoisomerase I Inhibitors , and New Strategies and Drugs Inhibiting Folate Pathways.

Therapeutic Antibody Engineering

Author : William R Strohl
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The field of antibody engineering has become a vital and integral part of making new, improved next generation therapeutic monoclonal antibodies, of which there are currently more than 300 in clinical trials across several therapeutic areas. Therapeutic antibody engineering examines all aspects of engineering monoclonal antibodies and analyses the effect that various genetic engineering approaches will have on future candidates. Chapters in the first part of the book provide an introduction to monoclonal antibodies, their discovery and development and the fundamental technologies used in their production. Following chapters cover a number of specific issues relating to different aspects of antibody engineering, including variable chain engineering, targets and mechanisms of action, classes of antibody and the use of antibody fragments, among many other topics. The last part of the book examines development issues, the interaction of human IgGs with non-human systems, and cell line development, before a conclusion looking at future issues affecting the field of therapeutic antibody engineering. Goes beyond the standard engineering issues covered by most books and delves into structure-function relationships Integration of knowledge across all areas of antibody engineering, development, and marketing Discusses how current and future genetic engineering of cell lines will pave the way for much higher productivity

Antibody Engineering

Author : Roland E. Kontermann
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Antibodies are indispensable tools for research, diagnosis, and therapy. Recombinant approaches allow the modification and improvement of nearly all antibody properties, such as affinity, valency, specificity, stability, serum half-life, effector functions, and immunogenicity. "Antibody Engineering" provides a comprehensive toolbox covering the well-established basics but also many exciting new techniques. The protocols reflect the latest "hands on" knowledge of key laboratories in this still fast-moving field. Newcomers will benefit from the proven step-by-step protocols, which include helpful practical advice; experienced antibody engineers will appreciate the new ideas and approaches. The book is an invaluable resource for all those engaged in antibody research and development.

Aggregation of Therapeutic Proteins

Author : Wei Wang
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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.

Drug Drug Interactions for Therapeutic Biologics

Author : Honghui Zhou
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Strategize, plan, and execute comprehensive drug-druginteraction assessments for therapeutic biologics Offering both theory and practical guidance, this book fullyexplores drug-drug interaction assessments for therapeuticbiologics during the drug development process. It draws togetherand analyzes all the latest findings and practices in order topresent our current understanding of the topic and point the way tonew research. Case studies and examples, coupled with expertadvice, enable readers to better understand the complex mechanismsof biologic drug-drug interactions. Drug-Drug Interactions for Therapeutic Biologics featurescontributions from leading international experts in all areas oftherapeutic biologics drug development and drug-drug interactions.The authors' contributions reflect a thorough review and analysisof the literature as well as their own firsthand laboratoryexperience. Coverage includes such essential topics as: Drug-drug interaction risks in combination with small moleculesand other biologics Pharmacokinetic and pharmacodynamic drug-drug interactions In vitro methods for drug-drug interaction assessment andprediction Risk-based strategies for evaluating biologic drug-druginteractions Strategies to minimize drug-drug interaction risk and mitigatetoxic interactions Key regulations governing drug-drug interaction assessments fortherapeutic biologics. Drug-Drug Interactions for Therapeutic Biologics isrecommended for pharmaceutical and biotechnology scientists,clinical pharmacologists, medicinal chemists, and toxicologists. Byenabling these readers to understand how therapeutic biologics mayinteract with other drugs, the book will help them develop safer,more effective therapeutic biologics.

Disease modifying Therapy in Vasculitides

Author : Cees G.M. Kallenberg
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Especially the past two decades have seen renewed interest in the vasculitides. In this volume an international expert group presents the current state of knowledge and concentrates on principles of immune modulating therapy. Drawing from their work in rheumatology, nephrology, internal medicine, connective tissue disease and clinical immunology, they present new concepts in classificiation, diagnosis and pathophysiology of the vasculitides. Evidence from experimental and clinical trials is reviewed, as well as the outlook for further research.

Animal Cell Culture

Author : Mohamed Al-Rubeai
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​Animal cells are the preferred “cell factories” for the production of complex molecules and antibodies for use as prophylactics, therapeutics or diagnostics. Animal cells are required for the correct post-translational processing (including glycosylation) of biopharmaceutical protein products. They are used for the production of viral vectors for gene therapy. Major targets for this therapy include cancer, HIV, arthritis, cardiovascular and CNS diseases and cystic fibrosis. Animal cells are used as in vitro substrates in pharmacological and toxicological studies. This book is designed to serve as a comprehensive review of animal cell culture, covering the current status of both research and applications. For the student or R&D scientist or new researcher the protocols are central to the performance of cell culture work, yet a broad understanding is essential for translation of laboratory findings into the industrial production. Within the broad scope of the book, each topic is reviewed authoritatively by experts in the field to produce state-of-the-art collection of current research. A major reference volume on cell culture research and how it impacts on production of biopharmaceutical proteins worldwide, the book is essential reading for everyone working in cell culture and is a recommended volume for all biotechnology libraries.

Cell Technology for Cell Products

Author : Rodney Smith
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The 19th ESACT meeting was to highlight the novel capabilities of the industry to move the products towards the clinic. It was attended by a wide range of workers in the industry and for many it was their first ESACT meeting. The proceedings here include the short papers adding the knowledge of the previous meetings and provide a reference for the researcher entering, or continuing in the field of Animal Cell Technology.

Therapeutic Targets of the TNF Superfamily

Author : Iqbal S. Grewal
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Tumor necrosis factor (TNF) superfamily is a rapidly growing family of cytokines that interacts with a corresponding superfamily of receptors. Liga- receptor interactions of this superfamily are involved in numerous biological processes ranging from hematopoiesis to pleiotropic cellular responses, including activation, proliferation, differentiation, and apoptosis. The particular response depends on the receptor, the cell type, and the concurrent signals received by the cell. Worldwide interest in the TNF field surged dramatically early in 1984 with the cloning and defining of the profound cellular effects of the first member of this family, TNF . Subsequently, the major influence of TNF on the development and functioning of the immune system was established. Today, over 20 human TNF ligands and their more than 30 corresponding receptors have been identified. Few receptors still remain orphans. What has emerged over the years is that most TNF ligands bind to one distinct receptor and some of the TNF ligands are able to bind to multiple TNF receptors, explaining to some extent the apparent disparity in the number of TNF receptors and ligands. Yet, in spite of some redundancy in TNF ligand/receptor interactions, it is clear that in vivo spatial, temporal, and indeed cell- and tissue-specific expression of both ligands and their receptors are important factors in determining the precise nature of cellular, physiological and pathological processes they control. TNF superfamily has been the most highly investigated area of basic medical research for over two decades.

Biotechnology and Biopharmaceuticals

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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.

Applications And Engineering Of Monoclonal Antibodies

Author : David J. King
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A valuable resource for researchers and workers in the fields of both pharmaceuticals and biotechnology as well as undergraduates in biochemistry, applied biology, biomedical sciences and pharmacy, this book compares established techniques of antibody production with the new. Antibody structure and the implications of antibody engineering are fully discussed, and a case study approach illustrates how antibodies are finding increasing use in the diagnosis and treatment of disease. The volume ends with commercial expression, purification and large-scale manufacture of antibodies and their future potential, particularly as therapeutic agents.