Fusion Protein Technologies for Biopharmaceuticals

The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA) Development of the design space for a manufacturing process How to employ QbD to design a formulation process Raw material analysis and control strategy for QbD Process Analytical Technology (PAT) and how it relates to QbD Relevant PAT tools and applications for the pharmaceutical industry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.

The latest edition of this highly acclaimed textbook, provides a comprehensive and up-to-date overview of the science and medical applications of biopharmaceutical products. Biopharmaceuticals refers to pharmaceutical substances derived from biological sources, and increasingly, it is synonymous with 'newer' pharmaceutical substances derived from genetic engineering or hybridoma technology. This superbly written review of the important areas of investigation in the field, covers drug production, plus the biochemical and molecular mechanisms of action together with the biotechnology of major biopharmaceutical types on the market or currently under development. There is also additional material reflecting both the technical advances in the area and detailed information on key topics such as the influence of genomics on drug discovery.

Written for industrial and academic researchers and development scientists in the life sciences industry, Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts is a guide to the tools, approaches, and useful developments in bioprocessing. This important guide: • Summarizes state-of-the-art bioprocessing methods and reviews applications in life science industries • Includes illustrative case studies that review six milestone bio-products • Discuses a wide selection of host strain types and disruptive bioprocess technologies

This collection of high-profile contributions provides a unique insight into the development of novel, successful biopharmaceuticals. Outstanding authors, including Nobel laureate Robert Huber as well as prominent company researchers and CEOs, present valuable insider knowledge, limiting their scope to those procedures and developments with proven potential for the biotechnology industry. They cover all relevant aspects, from the establishment of biotechnology parks, the development of successful compounds and the implementation of efficient manufacturing processes, right up to the establishment of advanced delivery routes.

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.

Chitosan is a linear polysaccharide commercially produced by the deacetylation of chitin. It is non-toxic, biodegradable, biocompatible, and acts as a bioadhesive with otherwise unstable biomolecules – making it a valuable component in the formulation of biopharmaceutical drugs. Chitosan-Based Systems for Biopharmaceuticals provides an extensive overview of the application of chitosan and its derivatives in the development and optimisation of biopharmaceuticals. The book is divided in four different parts. Part I discusses general aspects of chitosan and its derivatives, with particular emphasis on issues related to the development of biopharmaceutical chitosan-based systems. Part II deals with the use of chitosan and derivatives in the formulation and delivery of biopharmaceuticals, and focuses on the synergistic effects between chitosan and this particular subset of pharmaceuticals. Part III discusses specific applications of chitosan and its derivatives for biopharmaceutical use. Finally, Part IV presents diverse viewpoints on different issues such as regulatory, manufacturing and toxicological requirements of chitosan and its derivatives related to the development of biopharmaceutical products, as well as their patent status, and clinical application and potential. Topics covered include: chemical and technological advances in chitins and chitosans useful for the formulation of biopharmaceuticals physical properties of chitosan and derivatives in sol and gel states absorption promotion properties of chitosan and derivatives biocompatibility and biodegradation of chitosan and derivatives biological and pharmacological activity of chitosan and derivatives biological, chemical and physical compatibility of chitosan and biopharmaceuticals approaches for functional modification or crosslinking of chitosan use of chitosan and derivatives in conventional biopharmaceutical dosage forms manufacture techniques of chitosan-based microparticles and nanoparticles for biopharmaceuticals chitosan and derivatives for biopharmaceutical use: mucoadhesive properties chitosan-based systems for mucosal delivery of biopharmaceuticals chitosan-based delivery systems for mucosal vaccination chitosan-based nanoparticulates for oral delivery of biopharmaceuticals chitosan-based systems for ocular delivery of biopharmaceuticals chemical modification of chitosan for delivery of DNA and siRNA target-specific chitosan-based nanoparticle systems for nucleic acid delivery functional PEGylated chitosan systems for biopharmaceuticals stimuli-sensitive chitosan-based systems for biopharmaceuticals chitosan copolymers for biopharmaceuticals application of chitosan for anti-cancer biopharmaceutical delivery chitosan-based biopharmaceuticals scaffolds in tissue engineering and regenerative medicine wound healing properties of chitosan and its use in wound dressing biopharmaceuticals toxicological properties of chitosan and derivatives for biopharmaceutical applications regulatory status of chitosan and derivatives patentability and intellectual property issues quality control and good manufacturing practice preclinical and clinical use of chitosan and derivatives for biopharmaceuticals Chitosan-Based Systems for Biopharmaceuticals is an important compendium of fundamental concepts, practical tools and applications of chitosan-based biopharmaceuticals for researchers in academia and industry working in drug formulation and delivery, biopharmaceuticals, medicinal chemistry, pharmacy, bioengineering and new materials development.

A broad overview of the home networking field, ranging from wireless technologies to practical applications In the future, it is expected that private networks (e.g., home networks) will become part of the global network ecosystem, participating in sharing their own content, running IP-based services, and possibly becoming service providers themselves. This is already happening in the so-called «social networks» and peer-to-peer file sharing networks on the Internet—making this emerging topic one of the most active research areas in the wireless communications field. This book bridges the gap between wireless networking and service research communities, which, until now, have confined their work to their respective fields. Here, a number of industry professionals and academic experts have contributed chapters on various aspects of the subject to present an overview of home networking technologies with a special emphasis on the user as the center of all activities. Coverage includes: Networked home use cases and scenarios Media format, media exchange, and media interoperability Location-aware device and service discovery Security in smart homes Secure service discovery protocol implementation for wireless ad-hoc networks Multimedia content protection in consumer networks Mobile device connectivity in home networks Unlicensed mobile access/generic access network Wireless sensor networks in the home Ultra-wideband and sensor networking in the home environment With a balanced mix of practice and theory, Technologies for Home Networking focuses on the latest technologies for speedier, more reliable wireless networking and explains how to facilitate workable end-to-end solutions from a user's perspective. This book is an ideal resource for practicing engineers, designers, and managers with an interest in home networking and also serves as a valuable text for graduate students.

A complete overview of solar technologies relevant to the built environment, including solar thermal energy for heating and cooling, passive solar energy for daylighting and heating supply, and photovoltaics for electricity production Provides practical examples and calculations to enable component and system simulation e.g. Calculation of U-values, I-V curve parameters and radiance distribution modelling Discusses the new trends in thermal energy use, including the architectural integration of collector systems, integrated ventilation photovoltaics facades and solar powered absorption cooling systems Coverage of cutting-edge applications such as active and passive cooling techniques and results from ongoing research projects

“Emerging Technologies for Healthcare” begins with an IoT-based solution for the automated healthcare sector which is enhanced to provide solutions with advanced deep learning techniques. The book provides feasible solutions through various machine learning approaches and applies them to disease analysis and prediction. An example of this is employing a three-dimensional matrix approach for treating chronic kidney disease, the diagnosis and prognostication of acquired demyelinating syndrome (ADS) and autism spectrum disorder, and the detection of pneumonia. In addition, it provides healthcare solutions for post COVID-19 outbreaks through various suitable approaches, Moreover, a detailed detection mechanism is discussed which is used to devise solutions for predicting personality through handwriting recognition; and novel approaches for sentiment analysis are also discussed with sufficient data and its dimensions. This book not only covers theoretical approaches and algorithms, but also contains the sequence of steps used to analyze problems with data, processes, reports, and optimization techniques. It will serve as a single source for solving various problems via machine learning algorithms.

With the expectation of greatly enhanced user experience, 3D video is widely perceived as the next major advancement in video technology. In order to fulfil the expectation of enhanced user experience, 3D video calls for new technologies addressing efficient content creation, representation/coding, transmission and display. Emerging Technologies for 3D Video will deal with all aspects involved in 3D video systems and services, including content acquisition and creation, data representation and coding, transmission, view synthesis, rendering, display technologies, human perception of depth and quality assessment. Key features: Offers an overview of key existing technologies for 3D video Provides a discussion of advanced research topics and future technologies Reviews relevant standardization efforts Addresses applications and implementation issues Includes contributions from leading researchers The book is a comprehensive guide to 3D video systems and services suitable for all those involved in this field, including engineers, practitioners, researchers as well as professors, graduate and undergraduate students, and managers making technological decisions about 3D video.