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.
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.
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: 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.
Comprehensive reference source for the development, production and therapeutic application of antibodies. Volume I contains general chapters presenting established technologies and clinical applications. Volume II provides a look at emerging technologies, new therapeutic concepts, and clinical studies. Volume III features detailed and specific information about each currently approved type of antibody, including the clinical data.
This unique reference is the only drug-based therapeutics book in dermatology published in more than a decade. It covers the full spectrum of drugs prescribed for cutaneous diseases, including numerous topical, intralesional, and systemic drugs. To ensure quick access to information, each chapter features 5-10 drug tables; pharmacology key concepts; mechanisms of action; indications and contraindications; adverse effects; monitoring guidelines; and drug interactions. The tables alone make this reference a practical, convenient, and unique resource for the busy practitioner. Covers all dermatological drugs likely to be prescribed, with a focus on safe and effective use throughout. Provides on-the-spot information regarding monitoring and informing patients about important adverse effects to report. Features multiple headings and subheadings and hundreds of easy-access tables for fast access to vital information. Lists costs for all major drugs, both trade and generic. Includes a highly detailed, disease-specific index, helping the reader evaluate drug options for each disease discussed. Contains Black Box monitoring guidelines that list the most important baseline and follow-up examinations and laboratory tests required for safe use of more than 25 common drugs.
This book provides a comprehensive distillation of the clinical experience with Tumor Necrosis Factor (TNF) blocking therapy drugs combined with the diverse available databases to provide practical information about the use of these drugs in daily practice.
"...very informative and comprehensive...belongs on the shelf ofevery library and lab providing essential resources for research onvector design or delivery." -Cancer Biology and Therapy This comprehensive volume presents the most recent advances intarget definition technology and provides a detailed overview onthe rational design of targeted vectors for gene therapy. Atheoretical framework for advanced vector design is provided thatintegrates all of the allied sciences relevant to the study ofvector targeting. The text discusses the basic underlying scienceand then leads to discussions of the various viral vectors andmethods of defining targets. Finally, an expert outlook onpromising therapeutic applications is offered.
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.
Considers the genetic basis of disease and gene therapies, concentrating in detail on specific genetic illnesses, such as AIDS, cancer and cardiovascular diseases, and their treatment. This text should be of interest to pharmacists and to those involved in the biological or medical sciences.