Download or read book Therapeutic Fc Fusion Proteins written by Steven M. Chamow and published by John Wiley & Sons. This book was released on 2013-12-18 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Fusion Protein Technologies for Biopharmaceuticals written by Stefan R. Schmidt and published by John Wiley & Sons. This book was released on 2013-01-28 with total page 995 pages. Available in PDF, EPUB and Kindle. Book excerpt: The state of the art in biopharmaceutical FUSION PROTEIN DESIGN Fusion proteins belong to the most lucrative biotech drugs—with Enbrel® being one of the best-selling biologics worldwide. Enbrel® represents a milestone of modern therapies just as Humulin®, the first therapeutic recombinant protein for human use, approved by the FDA in 1982 and Orthoclone® the first monoclonal antibody reaching the market in 1986. These first generation molecules were soon followed by a plethora of recombinant copies of natural human proteins, and in 1998, the first de novo designed fusion protein was launched. Fusion Protein Technologies for Biopharmaceuticals examines the state of the art in developing fusion proteins for biopharmaceuticals, shedding light on the immense potential inherent in fusion protein design and functionality. A wide pantheon of international scientists and researchers deliver a comprehensive and complete overview of therapeutic fusion proteins, combining the success stories of marketed drugs with the dynamic preclinical and clinical research into novel drugs designed for as yet unmet medical needs. The book covers the major types of fusion proteins—receptor-traps, immunotoxins, Fc-fusions and peptibodies—while also detailing the approaches for developing, delivering, and improving the stability of fusion proteins. The main body of the book contains three large sections that address issues key to this specialty: strategies for extending the plasma half life, the design of toxic proteins, and utilizing fusion proteins for ultra specific targeting. The book concludes with novel concepts in this field, including examples of highly relevant multifunctional antibodies. Detailing the innovative science, commercial realities, and brilliant potential of fusion protein therapeutics, Fusion Protein Technologies for Biopharmaceuticals is a must for pharmaceutical scientists, biochemists, medicinal chemists, molecular biologists, pharmacologists, and genetic engineers interested in determining the shape of innovation in the world of biopharmaceuticals.
Download or read book Antibody Fusion Proteins written by Steven M. Chamow and published by Wiley-Liss. This book was released on 1999-04-13 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Approaches to the Purification Analysis and Characterization of Antibody Based Therapeutics written by Allan Matte and published by Elsevier. This book was released on 2020-09-07 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics provides the interested and informed reader with an overview of current approaches, strategies and considerations relating to the purification, analytics and characterization of therapeutic antibodies and related molecules. While there are obviously other books published in and around this subject area, they seem to be either older (c.a. year 2000 publication date) or are more limited in scope. The book will include an extensive bibliography of the published literature in the respective areas covered. It is not, however, intended to be a how-to methods book. Covers the vital new area of R&D on therapeutic antibodies Written by leading scientists and researchers Up-to-date coverage and includes a detailed bibliography
Download or read book Fc fusion Proteins as Adjuvants and Therapeutic Reagents written by David Mekhaiel and published by . This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Therapeutic Monoclonal Antibodies written by Zhiqiang An and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 932 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Safety of Biologics Therapy written by Brian A. Baldo and published by Springer. This book was released on 2016-08-12 with total page 623 pages. Available in PDF, EPUB and Kindle. Book excerpt: This long overdue title provides a comprehensive, up-to-date, state-of-the art review of approved biologic therapies, with coverage of mechanisms of action, Indications for therapy, immunogenicity and a detailed examination of adverse effects and safety of the many and diverse therapeutic agents presented in a total of 13 chapters. It is predicted that by 2016, biologics will make up half of the world's 20 top-selling drugs and by 2018, biologic medicine sales will account for almost half of the world's 100 biggest selling drugs. Recombinant proteins dominate the growing list of the more than 200 approved biotherapeutic agents with targeted antibodies, fusion proteins and receptors; cytokines; hormones; enzymes; proteins involved in blood-clotting, homeostasis and thrombosis; vaccines; botulinum neurotoxins; and, more recently, biosimilar preparations, comprising the majority of approved biologics. Written with clinicians, other health care professionals, and researchers in mind, Safety of Biologics Therapy examines, in a single volume, the full range of issues surrounding the safety of approved biologic therapies. A good understanding of the risks and safety issues of modern biologics therapy is increasingly being demanded of all those connected with their development, handling, prescribing, administration and subsequent patient management. In addition to being of great value to clinicians in all branches of medicine, and to nurses, pharmacists and researchers, this book will prove invaluable for students taking undergraduate and graduate courses in the above disciplines and in the biomedical sciences.
Download or read book Antibody Engineering Volume 2 written by Roland E. Kontermann and published by Springer Science & Business Media. This book was released on 2010-03-10 with total page 578 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Antibody Fc written by Margaret Ackerman and published by Academic Press. This book was released on 2013-08-06 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: Antibody Fc is the first single text to synthesize the literature on the mechanisms underlying the dramatic variability of antibodies to influence the immune response. The book demonstrates the importance of the Fc domain, including protective mechanisms, effector cell types, genetic data, and variability in Fc domain function. This volume is a critical single-source reference for researchers in vaccine discovery, immunologists, microbiologists, oncologists and protein engineers as well as graduate students in immunology and vaccinology. Antibodies represent the correlate of protection for numerous vaccines and are the most rapidly growing class of drugs, with applications ranging from cancer and infectious disease to autoimmunity. Researchers have long understood the variable domain of antibodies, which are responsible for antigen recognition, and can provide protection by blocking the function of their target antigen. However, recent developments in our understanding of the protection mediated by antibodies have highlighted the critical nature of the antibody constant, or Fc domain, in the biological activity of antibodies. The Fc domain allows antibodies to link the adaptive and innate immune systems, providing specificity to a wide range of innate effector cells. In addition, they provide a feedback loop to regulate the character of the immune response via interactions with B cells and antigen-presenting cells. - Clarifies the different mechanisms of IgG activity at the level of the different model systems used, including human genetic, mouse, and in vitro - Covers the role of antibodies in cancer, infectious disease, and autoimmunity and in the setting of monoclonal antibody therapy as well as naturally raised antibodies - Color illustrations enhance explanations of the immune system
Download or read book Challenges in Protein Product Development written by Nicholas W. Warne and published by Springer. This book was released on 2018-06-20 with total page 596 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Handbook of Therapeutic Antibodies written by Stefan Dübel and published by John Wiley & Sons. This book was released on 2014-12-03 with total page 2538 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dieses Nachschlagewerk zu therapeutischen Antikörpern sucht auch in der komplett überarbeiteten 2. Auflage seinesgleichen und bietet 30 % neue Inhalte zu Entwicklung, Herstellung und therapeutischen Anwendungen dieser Biomoleküle.
Download or read book Process Development and Characterization of Plant Recombinant Fc fusion Therapeutics written by Yongao Xiong and published by . This book was released on 2020 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Fragment crystallizable (Fc) fusion proteins are an important class of biologics consisting of a protein of interest fused to a constant domain of an immunoglobulin (Ig) with improved serum half-life and enhanced activity in some cases. This work discusses the process development of a Nicotiana benthamiana-based whole plant transient platform for on-demand manufacturing of two Fc-fusion therapeutics intended for anthrax toxin neutralization during an outbreak (capillary morphogenesis gene 2 (CMG2) Fc fusion protein, namely CMG2-Fc) and reversing microgravity-induced bone loss in space missions (Parathyroid hormone (PTH) Fc fusion protein, namely PTH-Fc). Transient expression is achieved by infiltration of an engineered disarmed plant pathogen called Agrobacterium tumefacien, allowing for horizontal transfer of the expression cassette into plant nucleus and production of the target protein within days. Despite the great potential of transient plant-based platforms, there is no whole plant recombinant therapeutic approved by FDA on the market. One regulatory concern of such a system is the difference in N-glycosylation between human and plant. To address this issue, a bioprocessing approach of adding a glycosidase inhibitor, kifunensine, in the infiltration buffer to eliminate plant specific glycoforms was investigated and summarized in Chapter 3. An almost complete inhibition was achieved with kifunesine addition at micromolar level. This approach realizes glycoform control via process modification and can be applicable to other N-glycan-containing proteins of interest. To further understand the effects of N-glycosylation on protein properties, a comprehensive study on N-glycosylation of CMG2-Fc was conducted and summarized in Chapter 4. Three glycoform variants of CMG2-Fc including plant-complex type (APO), a mixture of plant-complex type and oligomannose-tyope (ER) and Aglycosylated (Agly)were produced in plant transiently. Glycosylated variants (ER and APO) showed a higher expression and less protein degradation compared to the non-glycosylated variant (Agly). Once purified, the amino acid sequence, N-glycosylation profile, binding kinetics to the protective antigen (an anthrax toxin), toxin neutralization efficiency, thermostability and molecular dynamics of the CMG2-Fc variants were characterized to compare their stability and functionality. The downstream process of whole plant recombinant protein recovery and purification presents unique challenges, especially in the protein extraction step. To address those difficulties, the effects of extraction buffer pH and buffer additives on the extraction efficiency and protein stability were studied (Chapter 5), aiming for a high recovery of the target protein while minimizing impurities in the crude extract. In addition, to remove product related impurities (protein fragments and aggregates), a polishing chromatography was developed using hydrophobic interaction resins. With the implementation of this polishing step, a high-resolution separation was achieved for the non-glycosylated CMG2-Fc (Agly) variant with a partial separation for the glycosylated CMG2-Fc variants (ER and APO). The impacts of glycosylation and impurity species on peak resolution was discussed. Lastly, a comprehensive study on PTH-Fc, the bone regenerative medicine was conducted and summarized in Chapter 6. The protein accumulation kinetics profile was established, and the optimal harvest time was determined to be 5 days post-infiltration. Once purified, the amino acid sequence, binding affinity to PTH receptor 1 (PTH1R), and PTH1R receptor stimulation efficiency in cell culture of the PTH-Fc were characterized and compared to its native form, PTH (1-34).
Download or read book Therapeutic Antibody Engineering written by William R Strohl and published by Elsevier. This book was released on 2012-10-16 with total page 697 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Process Scale Purification of Antibodies written by Uwe Gottschalk and published by John Wiley & Sons. This book was released on 2017-03-07 with total page 849 pages. Available in PDF, EPUB and Kindle. Book excerpt: Promoting a continued and much-needed renaissance in biopharmaceutical manufacturing, this book covers the different strategies and assembles top-tier technology experts to address the challenges of antibody purification. • Updates existing topics and adds new ones that include purification of antibodies produced in novel production systems, novel separation technologies, novel antibody formats and alternative scaffolds, and strategies for ton-scale manufacturing • Presents new and updated discussions of different purification technologies, focusing on how they can address the capacity crunch in antibody purification • Emphasizes antibodies and innovative chromatography methods for processing
Download or read book Antibody Drug Discovery written by Clive R. Wood and published by World Scientific. This book was released on 2012 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: Antibody-based therapeutics are a central driver of the success of biopharmaceuticals. The discovery technology of this field is isolated to a limited number of centers of excellence in industry and academia. The objective of this volume is to provide a series of guides to those evaluating and preparing to enter particular areas within the field. Each chapter is written with a historical perspective that sets into context the significance of the key developments, and with the provision of “points to consider” for the reader as a value-added feature of the volume. All contributors are experts in their fields and have played pivotal roles in the creation of the technology.
Download or read book Antibody Fc Engineering Towards Better Therapeutics written by Tianlei Ying and published by Frontiers Media SA. This book was released on 2018-12-21 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Monoclonal Antibodies written by Maher Albitar and published by Springer Science & Business Media. This book was released on 2008-02-02 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines a collection of state-of-the-art methods that employ monoclonal antibodies in a clinical setting. The chapters offer in-depth description for generating mouse and recombinant humanized antibodies, and a comprehensive review of how antibodies are being used in bead-based methods for measuring proteins. This field will continue to expand and provide new and innovative techniques in the laboratory and as a basis that complements targeted therapy.
