This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch a lyophilized biologics or vaccine product, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fused), complex biologics (e.g., antibody drug conjugate, PEGylated proteins), and vaccines (e.g., recombinant-protein based). The authors adeptly guide the reader through all crucial aspects, from biophysical and chemical stability considerations of proteins, analytical methods, advances in controlled ice nucleation and quality-by-design approaches, alternate drying technology, to latest regulatory, packaging and technology transfer considerations to develop a stable, safe and effective therapeutic protein, vaccine and biotechnology products. Lyophilized Biologics and Vaccines: Modality-Based Approaches is composed of four sections with a total of 17 chapters. It serves as a reference to all critical assessments and steps from early pre-formulation stages to product launch: Provides recent understanding of heterogeneity of protein environment and selection of appropriate buffer for stabilization of lyophilized formulations Details the latest developments in instrumental analysis and controlled ice nucleation technology Explains in-depth lyophilized (or dehydrated) formulation strategies considering diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics Details an exhaustive update on quality-by-design and process analytical technology approaches, illustrated superbly by case studies and FDA perspective Provides the latest detailed account of alternate drying technologies including spray drying, bulk freeze-drying and crystallization, supported exceptionally by case studies Provides a step-by-step guide through critical considerations during process scale-up, technology transfer, packaging and drug delivery device selection, for a successful lyophilization process validation, regulatory submission and product launch Chapters are written by one or more world-renowned leading authorities from academia, industry or regulatory agencies, whose expertise cover lyophilization of the diverse modalities of biopharmaceuticals. Their contributions are based on the exhaustive review of literature coupled with excellent hands-on experiences in laboratory or GMP setup, making this an exceptional guide to all stages of lyophilized or dehydrated product development.

A comprehensive overview of the current research on inflammation and immunopharmacology, with particular attention to the use of anti-inflammatory drugs, this book discusses future trends in this area of pharmacological research. It addresses an audience with basic knowledge in the inflammatory process, immune system and pharmacology. The book meets the needs of graduate students, junior and senior researchers and is useful as a source of the most current information for those already working in these fields.

Quality Determinants In Coffee Production presents a comprehensive overview of the main determinants of coffee quality during processing. Authored by members of the Laboratory for Analysis and Research in Coffee at the Federal Institute of Espirito Santo, the chapters in this text explain how coffee quality can be affected through each step of the main processing methods. The first section explores the history of coffee processing, covering how the processes and techniques of sensorial analysis have developed. The second section covers the evolution of these techniques and how various complexities can affect their use, plus the statistical tools that are used to increase test accuracy. Another section focuses on the relationship between fruit microbiology and coffee quality, promoting an understanding of how yeasts, fungi and bacteria effect the quality of coffee during processing. Another section is dedicated to the biotechnological processes used in coffee production, including the applicability of induced and spontaneous routes from the manipulation of raw material, the relationship between wet processing and spontaneous fermentation and the construction of sensorial routes. A final section explores volatile coffee compounds and gas chromatography techniques, including chemical and sensory maps. The majority of the reference works published on coffee processing have a pragmatic approach covering production, harvesting, post-harvesting and marketing. This work goes beyond these subjects, covering the factors that impact quality and how they lead to either qualitative reduction or gains during processing. New technological and scientific indicators for the modification and the creation of sensory routes are extensively covered, as are the international protocols used in the sensorial analysis of coffee. With its broad approach, this text presents a multidisciplinary perspective connecting areas such as statistics, biochemistry, analytical chemistry and microbiology to the results of sensory analysis using different technologies and processes. A direct relationship between these factors is established in order to help researchers understand their combined effect on coffee quality during processing.

This book focuses on the assessment of different coal gasification technologies for the utilization of Russian coals with analyses of economically feasible process chains for preparation of marketable products from high-ash coals. The work presented is important in view of the general competitiveness that marks the future of coal in the world. As the cheapest form of fuel (in comparable terms) coal will undoubtedly be in demand resources in the world. The book consists of parts which include an overview about the major coal characteristics, detailed discussion of fundamental aspects of gasification technologies and gasifiers, an introduction into annex concepts, an overview about different technologies of syngas utilization, technical and economic assessment of several coal-to-liquid and coal-to-chemicals routes, and feasibility demonstration for selected process chains. This book is addressed to the management and engineers of Russian coal companies and scientific staff of Russian research institutions working in the field of coal utilization.

Detailed mathematical models are increasingly being used by companies to gain competitive advantage through such applications as model-based process design, control and optimization. Thus, building various types of high quality models for processing systems has become a key activity in Process Engineering. This activity involves the use of several methods and techniques including model solution techniques, nonlinear systems identification, model verification and validation, and optimal design of experiments just to name a few. In turn, several issues and open-ended problems arise within these methods, including, for instance, use of higher-order information in establishing parameter estimates, establishing metrics for model credibility, and extending experiment design to the dynamic situation.
The material covered in this book is aimed at allowing easier development and full use of detailed and high fidelity models. Potential applications of these techniques in all engineering disciplines are abundant, including applications in chemical kinetics and reaction mechanism elucidation, polymer reaction engineering, and physical properties estimation. On the academic side, the book will serve to generate research ideas.
- Contains wide coverage of statistical methods applied to process modelling
- Serves as a recent compilation of dynamic model building tools
- Presents several examples of applying advanced statistical and modelling methods to real process systems problems

Guaranteeing a high system performance over a wide operating range is an important issue surrounding the design of automatic control systems with successively increasing complexity. As a key technology in the search for a solution, advanced fault detection and identification (FDI) is receiving considerable attention. This book introduces basic model-based FDI schemes, advanced analysis and design algorithms, and mathematical and control-theoretic tools.
This second edition of Model-Based Fault Diagnosis Techniques contains:
new material on fault isolation and identification and alarm management;
extended and revised treatment of systematic threshold determination for systems with both deterministic unknown inputs and stochastic noises;
addition of the continuously-stirred tank heater as a representative process-industrial benchmark; and
enhanced discussion of residual evaluation which now deals with stochastic processes.
Model-based Fault Diagnosis Techniques will interest academic researchers working in fault identification and diagnosis and as a text it is suitable for graduate students in a formal university-based course or as a self-study aid for practising engineers working with automatic control or mechatronic systems from backgrounds as diverse as chemical process and power engineering.

The series Topics in Current Chemistry Collections presents critical reviews from the journal Topics in Current Chemistry organized in topical volumes. The scope of coverage is all areas of chemical science including the interfaces with related disciplines such as biology, medicine and materials science. The goal of each thematic volume is to give the non-specialist reader, whether in academia or industry, a comprehensive insight into an area where new research is emerging which is of interest to a larger scientific audience. Each review within the volume critically surveys one aspect of that topic and places it within the context of the volume as a whole. The most significant developments of the last 5 to 10 years are presented using selected examples to illustrate the principles discussed. The coverage is not intended to be an exhaustive summary of the field or include large quantities of data, but should rather be conceptual, concentrating on the methodological thinking that will allow the non-specialist reader to understand the information presented. Contributions also offer an outlook on potential future developments in the field.

Powder technology is a rapidly expanding technology and nowhere more than in particle characterization. There has been an explosion of new particle measuring techniques in the past ten year particularly in the field of on-line measurement. One of the main aims of this book is to bring the reader up-to-date with current practices. One important area of interest is the improvements in on-line light scattering instruments and the introduction of ultrasonic on-line devices. Another is the introduction of on-line microscopy, which permits shape analysis in conjunction with particle sizing.
Schools of powder technology are common in Europe and Japan but the importance of this subject has only recently been recognised in America with the emergence of the Particle Research Centre (PERC) at the University of Florida in Gainsville.
- Details all the latest developments in powder technology
- Written by established authority on powder technology
- A comprehensive text covering all aspects of powder technology and handling of particulate solids including characterization, handling and applications

This book covers nanotechnology based approaches for improving the therapeutic efficacy of natural products. It critically explores lipid nanoarchitectonics, inorganic particles and nanoemulsion based tools for delivering them. With its chapters from eminent experts working in this discipline, it is ideal for researchers and professionals working in the area.

The seafood processing industry produces a large amount of by-products that usually consist of bioactive materials such as proteins, enzymes, fatty acids, and biopolymers. These by-products are often underutilized or wasted, even though they have been shown to have biotechnological, nutritional, pharmaceutical, and biomedical applications. For example, by-products derived from crustaceans and algae have been successfully applied in place of collagen and gelatin in food, cosmetics, drug delivery, and tissue engineering. Divided into four parts and consisting of twenty-seven chapters, this book discusses seafood by-product development, isolation, and characterization, and demonstrates the importance of seafood by-products for the pharmaceutical, nutraceutical, and biomedical industries.

This book discusses the use of microorganisms for improving nutrient quality and producing healthier foods. Conventional roles of microbes in food preservation and in producing more readily digestible nutrients via natural fermentation processes are also examined. Individual chapters explore topics such as bio-preservation, incorporation of lactic acid bacteria, traditional fermented Mongolian foods, fermented fish products of Sudan, probiotics in China, fermented soymilk, food colorants, and the effect of food on gut microbiota. Readers will gain insights into current trends and future prospects of functional foods and nutraceuticals. This volume will be of particular interest to scientists working in the fields of food sciences, microbiology, agriculture and public health.

This book presents two main sets of paper-based analytical systems. The first set is a platform for the analysis of glucose, cholesterol and uric acid in biological samples, and the second set is a cutting-edge electronic tongue system for the analysis of beverages (mineral water, beer, wine). This thesis also provides an extensive review of 33 methods of enzyme immobilization on paper which have been evaluated to enhance the storage stability of the proposed system for biomarker detection. From a practical perspective, this thesis covers a diverse set of topics related to paper-based sensing, including colorimetric and electrochemical detection methods, different sets of architecture (spot-tests, lateral and tangential flow assays), methods of fabrication (wax printing, cutting, impregnation with polymers), measurements in stationary and flow conditions as well computer modeling of proposed systems and sophisticated data analysis using chemometric techniques. This book is useful for PhD students working in this or a related field who require detailed information about methodology and background to this research.

This book explores the use of recent advanced multiple stage conversion technologies. These applications combine conventional fluidised bed systems with new plasma technologies to efficiently generate different energy outputs from waste materials with minimum cleaning effort. Using a mix of modelling and experimental approaches, the author provides fundamental insights into how the key operating variables of the two-stage process may impact the final quality of syngas. This thesis serves as a useful reference guide on the modelling and design of single and multiple-stage systems for thermal waste treatment. Its extended section on plant configuration and operation of waste gasification plants identifies the main technical challenges, and is of use to researchers entering the field.

The purpose of this publication is to introduce a new, simpler and more effective way in which to interpret pharmaceutical aerosol particle size data from orally inhaled products (OIPs). Currently, the compendial and regulatory requirements dictate the need for measurements by full resolution multi-stage cascade impactor (CI), a process that is demanding for the operator, time consuming, prone to experimental error, and challenging for method transfers from one laboratory to another. Furthermore, we shall show that the current practice of reducing information from mass-weighted aerodynamic particle size distribution (APSD) measurements through the use of CI stage groupings is not the most effective decision-making tool for OIP quality control (QC) in comparison with newly introduced, mutually-independent efficient data analysis (EDA) metrics that can be derived either from full resolution or abbreviated impactor measurements (AIM).

This book demonstrates how imaging techniques, applying different frequency bands from the electromagnetic spectrum, are used in scientific research. Illustrated with numerous examples this book is structured according to the different radiation bands: From Gamma-rays over UV and IR to radio frequencies. In order to ensure a clear understanding of the processing methodologies, the text is enriched with descriptions of how digital images are formed, acquired, processed and how to extract information from them. A special emphasis is given to the application of imaging techniques in food and agriculture research.

This book investigates geopolymers and geopolymer-based composites, with a focus on their preparation, geopolymerization mechanisms, microstructures, mechanical properties, and fracture behaviors. Geopolymers are inorganic materials consisting of tetrahedral units (such as [SiO4] and [AlO4]) linked by shared oxygens and forming long-range, covalently bonded and amorphous frameworks. Geopolymers have the advantages of low-temperature preparation, low cost, high heat and corrosion resistance, and being environmentally friendly. Using the preparation methods for epoxy-based composite, they can easily be formed into complex shapes or structures. Intended for researchers investigating geopolymers and their matrix composite materials, this book is also a valuable resource for engineers from various fields, such as materials, mechanical, civil and structural engineering, as well as students interested in other kinds of inorganic materials or even cementitious materials in general.

This book covers several aspects of the synthesis of composites by the pressureless infiltration technique. It describes the methods used to obtain green preforms, such as cold pressed and hot sintering, describing the heating time, load, and time required for pressing the preforms. Additionally, wettability phenomena, which is directly related on infiltration, is extensively described. Wettability process and interfacial reactions are analyzed in many ceramic-metal systems prior to fabricate the composites. A complete description of fabrication processes for Metal Matrix Composites is included. An extensive section on structural, chemical, and mechanical characterization of composites fabricated with aluminum and magnesium alloys as matrices reinforced with titanium carbide (TiC), aluminum nitride (AlN), silicon carbide (SiC) and alumina (Al2O3) is included. Relevant techniques for joining composites, such as welding and brazing are addressed. As well as issues pertaining to the corrosion and wear of composites are discussed as well. Corrosion behavior of some composites exposed to aqueous media was analyzed. Corrosion of composites using TiC and SiC like reinforcement and Al, Ni, and some Al-Cux, Al-Mgx and Al-Cu-Li alloys like matrix is discussed extensively. The structural characterization techniques addressed include: scanning electron microscopy (SEM), X-ray diffraction (XRD), transmission electron microscopy (TEM), optical microscopy (OM), differential thermal analysis (DTA), high resolution transmission electron microscopy (HRTEM), and thermogravimetry analysis (TGA). Mechanical testing including hardness, elastic modulus, tension tests, and impact tests were used in the characterization of composites. Theoretical models for prediction of some mechanical properties are included too.

This third edition volume expands on the previous editions both by presenting more detailed protocols for the techniques described in the first and second editions of High Throughput Screening: Methods and Protocols and by covering important new procedures. The first chapter of this book provides an overview of important assay development techniques, while the rest of the chapters detail how to develop and execute screens at whatever throughput the user needs. Some chapter examples are: structure-based virtual screening, high throughput screening using mass spectrometry, identification of state-dependent blockers for voltage gated calcium channels, bioluminescence resonance energy transfer platform to monitor protein-protein interactions in live cells, high throughput flow cytometry, and application of imaging-based assays in microplate formats for high content screening. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Cutting edge and thorough, High Throughput Screening: Methods and Protocols, Third Edition, is a valuable resource for anyone who is interested in HTS research.

3D printing is forecast to revolutionise the pharmaceutical sector, changing the face of medicine development, manufacture and use. Potential applications range from pre-clinical drug development and dosage form design through to the fabrication of functionalised implants and regenerative medicine. Within clinical pharmacy practice, printing technologies may finally lead to the concept of personalised medicines becoming a reality. This volume aims to be the definitive resource for anyone thinking of developing or using 3D printing technologies in the pharmaceutical sector, with a strong focus on the translation of printing technologies to a clinical setting. This text brings together leading experts to provide extensive information on an array of 3D printing techniques, reviewing the current printing technologies in the pharmaceutical manufacturing supply chain, in particular, highlighting the state-of-the-art applications in medicine and discussing modern drug product manufacture from a regulatory perspective. This book is a highly valuable resource for a range of demographics, including academic researchers and the pharmaceutical industry, providing a comprehensive inventory detailing the current and future applications of 3D printing in pharmaceuticals. Abdul W. Basit is Professor of Pharmaceutics at the UCL School of Pharmacy, University College London. Abdul's research sits at the interface between pharmaceutical science and gastroenterology, forging links between basic science and clinical outcomes. He leads a large and multidisciplinary research group, and the goal of his work is to further the understanding of gastrointestinal physiology by fundamental research. So far, this knowledge has been translated into the design of new technologies and improved disease treatments, many of which are currently in late-stage clinical trials. He has published over 350 papers, book chapters and abstracts and delivered more than 250 invited research presentations. Abdul is also a serial entrepreneur and has filed 25 patents and founded 3 pharmaceutical companies (Kuecept, Intract Pharma, FabRx). Abdul is a frequent speaker at international conferences, serves as a consultant to many pharmaceutical companies and is on the advisory boards of scientific journals, healthcare organisations and charitable bodies. He is the European Editor of the International Journal of Pharmaceutics. Abdul was the recipient of the Young Investigator Award in Pharmaceutics and Pharmaceutical Technology from the American Association of Pharmaceutical Scientists (AAPS) and is the only non-North American scientist to receive this award. He was also the recipient of the Academy of Pharmaceutical Sciences (APS) award. Simon Gaisford holds a Chair in Pharmaceutics and is Head of the Department of Pharmaceutics at the UCL School of Pharmacy, University College London. He has published 110 papers, 8 book chapters and 4 authored books. His research is focused on novel technologies for manufacturing medicines, particularly using ink-jet printing and 3D printing, and he is an expert in the physico-chemical characterisation of compounds and formulations with thermal methods and calorimetry.

Food safety and quality are primary concerns in the food manufacturing industry. Written by an author with more than 35 years' experience in the food industry, Food Plant Sanitation: Design, Maintenance, and Good Manufacturing Practices, Second Edition provides completely updated practical advice on all aspects of food plant sanitation and sanitation-related food safety issues. It offers readers the tools to establish a food safety system to help control microbiological, physical, and chemical hazards. Understanding that sanitation is integral to food safety is the foundation for an effective food safety system. Beginning with that premise, this book presents some of the key components for such a system. The chapters address testing for and control of microorganisms in food manufacturing, including recent challenges in the industry due to pathogens such as Listeria monocytogenes. They also offer discussions on biofilms, regulatory requirements from the European Union, allergens, sanitary facility design, and describe proven best practices for sanitation as well as current sanitary requirements and regulatory changes from the FDA and USDA. In addition, the author presents methods for verifying sanitation. The final chapters identify good manufacturing practices for employees and present a comprehensive pest management plan, including control measures and chemical interventions. The book concludes with strategies for preventing chemical and physical food safety hazards. This reference provides a practical perspective for implementing food plant sanitation and safety processes. The author has included, wherever possible, examples of procedures, forms, and documents to help novice food safety and quality professionals develop effective food safety systems.