Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts

This book provides the vision of a successful biorefinery—the lignocelluloic biomass needs to be efficiently converted to its constituent monomers, comprising mainly of sugars such as glucose, xylose, mannose and arabinose. Accordingly, the first part of the book deals with aspects crucial for the pretreatment and hydrolysis of biomass to give sugars in high yield, as well as the general aspects of bioprocessing technologies which will enable the development of biorefineries through inputs of metabolic engineering, fermentation, downstream processing and formulation. The second part of the book gives the current status and future directions of the biological processes for production of ethanol (a biofuel as well as an important commodity raw material), solvents (butanol, isobutanol, butanediols, propanediols), organic acids (lactic acid, 3-hydroxy propionic acid, fumaric acid, succinic acid and adipic acid), and amino acid (glutamic acid). The commercial production of some of these commodity bioproducts in the near future will have a far reaching effect in realizing our goal of sustainable conversion of these renewable resources and realizing the concept of biorefinery. Suitable for researchers, practitioners, graduate students and consultants in biochemical/ bioprocess engineering, industrial microbiology, bioprocess technology, metabolic engineering, environmental science and energy, the book offers: Exemplifies the application of metabolic engineering approaches for development of microbial cell factories Provides a unique perspective to the industry about the scientific problems and their possible solutions in making a bioprocess work for commercial production of commodity bioproducts Discusses the processing of renewable resources, such as plant biomass, for mass production of commodity chemicals and liquid fuels to meet our ever- increasing demands Encourages sustainable green technologies for the utilization of renewable resources Offers timely solutions to help address the energy problem as non-renewable fossil oil will soon be unavailable

Sets the stage for large-scale production of biofuels and bio-based chemicals In response to diminishing supplies as well as the environmental hazards posed by fossil fuels and petrochemicals, interest and demand for green, sustainable biofuels and bio-based chemicals are soaring. Biomass may be the solution. It is an abundant carbon-neutral renewable feedstock that can be used for the production of fuels and chemicals. Currently, biorefineries use corn, soybeans, and sugarcane for bioethanol and biodiesel production; however, there are many challenges facing biorefineries, preventing biomass from reaching its full potential. This book provides a comprehensive review of bioprocessing technologies that use lignocellulosic biomass for the production of biofuels, biochemicals, and biopolymers. It begins with an overview of integrated biorefineries. Next, it covers: Biomass feedstocks, including sugar, starch, oil, and energy crops as well as microalgae Pretreatment technologies for lignocellulosic biomass Hydrolytic enzymes used in biorefineries for the hydrolysis of starch and lignocelluloses Bioconversion technologies for current and future biofuels such as ethanol, biodiesel, butanol, hydrogen, and biogas Specialty chemicals, building block chemicals, and biopolymers produced via fermentation Phytochemicals and functional food ingredients extracted from plant materials All the chapters have been written and edited by leading experts in bioprocessing and biorefining technologies. Contributions are based on a thorough review of the literature as well as the authors' firsthand experience developing and working with bioprocessing technologies. By setting forth the current state of the technology and pointing to promising new directions in research, Bioprocessing Technologies in Biorefinery for Sustainable Production of Fuels, Chemicals, and Polymers will enable readers to move towards large-scale, sustainable, and economical production of biofuels and bio-based chemicals.

With contributions from leading, international academics and industrial practitioners, Bioprocessing for Cell-Based Therapies explores the very latest techniques and guidelines in bioprocess production to meet safety, regulatory and ethical requirements, for the production of therapeutic cells, including stem cells. An authoritative, cutting-edge handbook on bioprocessing for the production of therapeutic cells with extensive illustrations in full colour throughout An authoritative, cutting-edge handbook on bioprocessing for the production of therapeutic cells with extensive illustrations in full colour throughout In depth discussion of the application of cell therapy including methods used in the delivery of cells to the patient Includes contributions from experts in both academia and industry, combining a practical approach with cutting edge research The only handbook currently available to provide a state of the art guide to Bioprocessing covering the complete range of cell-based therapies, from experts in academia and industry

The only comprehensive and authoritative reference guide to the ASME Bioprocessing Piping and Equipment (BPE) standard This is a companion guide to the ASME Bioprocessing Piping and Equipment (BPE) Standard and explains what lies behind many of the requirements and recommendations within that industry standard. Following an introductory narrative to the Standard's early history, industry related codes and standards are explained; the design and engineering aspects cover construction materials, both metallic and nonmetallic; then components, fabrication, assembly and installation of piping systems are explored. Examination, Inspection and Testing then precede the ASME BPE certification process, concluding with a discussion on system design. The author draws on many years' experience and insights from first-hand involvement in the field of industrial piping design, engineering, construction, and management, which includes the bioprocessing industry. The reader will learn why dimensions and tolerances, process instrumentation, and material selection play such an integral part in the manufacture of components and instrumentation. This easy to understand and navigate guide will assist engineers (design, piping, chemical, etc.) who need to understand the basis for much of the Standard’s content, as do the contractors and inspectors who have to meet and validate compliance with the BPE Standard.

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.

This book highlights the processes of biomass thermochemical conversion, covering topics from combustion and gasification, to pyrolysis and liquefaction. Heat, power, biofuels and green chemicals can all be produced by these thermochemical processes. The different scales of investigation are presented: from the bioenergy chains, to the reactors and molecular mechanisms. The author uses current research and data to present bioenergy chains from forest to final use, including the biomass supply chains, as well as the life cycle assessment of different process chains. Biomass conversion reactors are also presented, detailing their technologies for combustion, gasification and syngas up-grading systems, pyrolysis and bio-oil upgrading. The physical-chemical mechanisms occurring in all these reactors are presented highlighting the main pathways for gas, char and bio-oil formation from biomass. This book offers an overview of biomass valorization for students, engineers or developers in chemistry, chemical, environmental or mechanical engineering.

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.

Sets forth the state of the science and technology in plasma protein production With contributions from an international team of eighty leading experts and pioneers in the field, Production of Plasma Proteins for Therapeutic Use presents a comprehensive overview of the current state of knowledge about the function, use, and production of blood plasma proteins. In addition to details of the operational requirements for the production of plasma derivatives, the book describes the biology, development, research, manufacture, and clinical indications of essentially all plasma proteins with established clinical use or therapeutic potential. Production of Plasma Proteins for Therapeutic Use covers the key aspects of the plasma fractionation industry in five sections: Section 1: Introduction to Plasma Fractionation initially describes the history of transfusion and then covers the emergence of plasma collection and fractionation from its earliest days to the present time, with the commercial and not-for-profit sectors developing into a multi-billion dollar industry. Section 2: Plasma Proteins for Therapeutic Use contains 24 chapters dedicated to specific plasma proteins, including coagulation factors, albumin, immunoglobulin, and a comprehensive range of other plasma-derived proteins with therapeutic indications. Each chapter discusses the physiology, biochemistry, mechanism of action, and manufacture of each plasma protein including viral safety issues and clinical uses. Section 3: Pathogen Safety of Plasma Products examines issues and procedures for enhancing viral safety and reducing the risk of transmissible spongiform encephalopathy transmission. Section 4: The Pharmaceutical Environment Applied to Plasma Fractionation details the requirements and activities associated with plasma collection, quality assurance, compliance with regulatory requirements, provision of medical affairs support, and the manufacture of plasma products. Section 5: The Market for Plasma Products and the Economics of Fractionation reviews the commercial environment and economics of the plasma fractionation industry including future trends, highlighting regions such as Asia, which have the potential to exert a major influence on the plasma fractionation industry in the twenty-first century.

The book addresses the basics, applications, and manufacturing of plasmid biopharmaceuticals. The survey of the most relevant characteristics of plasmids provides the basics for designing plasmid products (applications) and processes (manufacturing). Key features that the authors include in the book are: i) consistency and clear line of direction, ii) an extensive use of cross-referencing between the individual chapters, iii) a rational integration of chapters, iv) appellative figures, tables and schemes, and v) an updated, but selected choice of references, with a focus on key papers.

About the book The book covers all aspects of fermentation technology such as principles, reaction kinetics, scaling up of processes, and applications. The 20 chapters written by subject matter experts are divided into two parts: Principles and Applications. In the first part subjects covered include: • Modelling and kinetics of fermentation technology; • Sterilization techniques used in fermentation processes; • Design and types of bioreactors used in fermentation technology. • Recent advances and future prospect of fermentation technology, The second part subjects covered incude: • Lactic acid and ethanol production using fermentation technology; • Various industrial value-added product biosynthesis using fermentation technology; • Microbial cyp450 production and its industrial application; • Polyunsaturated fatty acid production through solid state fermentation; • Application of oleaginous yeast for lignocellulosic biomass based single cell oil production; • Utilization of micro-algal biomass for bioethanol production; • Poly-lactide production from lactic acid through fermentation technology; • Bacterial cellulose and its potential impact on industrial applications.