Still the most comprehensive reference source on the development, production and therapeutic application of antibodies, this second edition is thoroughly updated and now has 30% more content. Volume 1 covers selection and engineering strategies for new antibodies, while the second volume presents novel therapeutic concepts and antibodies in clinical study, as well as their potential. Volumes 3 and 4 feature detailed and specific information about each antibody approved for therapeutic purposes, including clinical data. This unique handbook concludes with a compendium of marketed monoclonal antibodies and an extensive index. Beyond providing current knowledge, the authors discuss emerging technologies, future developments, and intellectual property issues, such that this handbook meets the needs of academic researchers, decision makers in industry and healthcare professionals in the clinic.
During the period 1981-1990 important research was recognized in areas as diverse as visual information processing, monoclonal antibodies, pharmacology, molecular biology and transplantation. Издательство: World Scientific PublishingАвтор: Jan Lindsten
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
With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.
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.
The definitive book on the neutralization of recombinant biopharmaceuticals Recombinant biopharmaceuticals are an important tool for treating a range of illnesses; however, their efficacy can be severely impaired by their immunogenicity. When introduced into the body, these pharmaceuticals can cause the immune system to produce anti-drug antibodies (ADAs) that neutralize their effects. The first and only book to cover neutralization in connection with biopharmaceuticals and the measurement and application of neutralizing antibodies in modern medicine at any real length, Detection and Quantification of Antibodies to Biopharmaceuticals: Practical and Applied Considerations offers a comprehensive and in-depth look at all the principal aspects of the detection and quantification of antibodies that are essential to understanding and responding to the challenges they present. Bringing together a large-scale review of neutralization and biopharmaceuticals and the ability to measure, detect, and apply antibodies to modern science and medicine with international regulatory perspectives, the expectations of regulatory authorities, and the strengths and weaknesses of various assays, the book describes several novel ideas for detecting ADAs. Designed to serve as a resource for biopharmaceutical drug development, the book provides biotechnology companies and pharmaceutical drug development specialists, as well as non-experts, with key insights into the design, optimization, and qualification of assays, the establishment of sampling strategies, the choice of appropriate assay end-points, and data analysis for the detection and quantification of neutralizing antibodies.
With an emphasis on the fundamental and practical aspects of ADME for therapeutic proteins, this book helps readers strategize, plan and implement translational research for biologic drugs. • Details cutting-edge ADME (absorption, distribution, metabolism and excretion) and PKPD (pharmacokinetic / pharmacodynamics) modeling for biologic drugs • Combines theoretical with practical aspects of ADME in biologic drug discovery and development and compares innovator biologics with biosimilar biologics and small molecules with biologics, giving a lessons-learned perspective • Includes case studies about leveraging ADME to improve biologics drug development for monoclonal antibodies, fusion proteins, pegylated proteins, ADCs, bispecifics, and vaccines • Presents regulatory expectations and industry perspectives for developing biologic drugs in USA, EU, and Japan • Provides mechanistic insight into biodistribution and target-driven pharmacokinetics in important sites of action such as tumors and the brain
Aquaculture is an increasingly diverse industry with an ever-growing number of species cultured and production systems available to professionals. A basic understanding of production systems is vital to the successful practice of aquaculture. Published with the World Aquaculture Society, Aquaculture Production Systems captures the huge diversity of production systems used in the production of shellfish and finfish in one concise volume that allows the reader to better understand how aquaculture depends upon and interacts with its environment. The systems examined range from low input methods to super-intensive systems. Divided into five sections that each focus on a distinct family of systems, Aquaculture Production Systems serves as an excellent text to those just being introduced to aquaculture as well as being a valuable reference to well-established professionals seeking information on production methods.
The Handbook of Speech Production is the first reference work to provide an overview of this burgeoning area of study. Twenty-four chapters written by an international team of authors examine issues in speech planning, motor control, the physical aspects of speech production, and external factors that impact speech production. Contributions bring together behavioral, clinical, computational, developmental, and neuropsychological perspectives on speech production to create a rich and truly interdisciplinary resource Offers a novel and timely contribution to the literature and showcases a broad spectrum of research in speech production, methodological advances, and modeling Coverage of planning, motor control, articulatory coordination, the speech mechanism, and the effect of language on production processes
The book is organized in three parts. Part I shows how the catalytic and electrochemical principles involve hydrogen production technologies. Part II is devoted to biohydrogen production and introduces gasification and fast pyrolysis biomass, dark fermentation, microbial electrolysis and power production from algae. The last part of the book is concerned with the photo hydrogen generation technologies. Recent developments in the area of semiconductor-based nanomaterials, specifically semiconductor oxides, nitrides and metal-free semiconductors based nanomaterials for photocatalytic hydrogen production are extensively discussed in this part.
Production-targeted Spark guidance with real-world use cases Spark: Big Data Cluster Computing in Production goes beyond general Spark overviews to provide targeted guidance toward using lightning-fast big-data clustering in production. Written by an expert team well-known in the big data community, this book walks you through the challenges in moving from proof-of-concept or demo Spark applications to live Spark in production. Real use cases provide deep insight into common problems, limitations, challenges, and opportunities, while expert tips and tricks help you get the most out of Spark performance. Coverage includes Spark SQL, Tachyon, Kerberos, ML Lib, YARN, and Mesos, with clear, actionable guidance on resource scheduling, db connectors, streaming, security, and much more. Spark has become the tool of choice for many Big Data problems, with more active contributors than any other Apache Software project. General introductory books abound, but this book is the first to provide deep insight and real-world advice on using Spark in production. Specific guidance, expert tips, and invaluable foresight make this guide an incredibly useful resource for real production settings. Review Spark hardware requirements and estimate cluster size Gain insight from real-world production use cases Tighten security, schedule resources, and fine-tune performance Overcome common problems encountered using Spark in production Spark works with other big data tools including MapReduce and Hadoop, and uses languages you already know like Java, Scala, Python, and R. Lightning speed makes Spark too good to pass up, but understanding limitations and challenges in advance goes a long way toward easing actual production implementation. Spark: Big Data Cluster Computing in Production tells you everything you need to know, with real-world production insight and expert guidance, tips, and tricks.