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.

Development of new-generation vaccines is now more challenging than ever, as identifying, purifying and evaluating vaccine antigens is a complex undertaking. Most importantly, once the relevant antigens have been identified, key focus then shifts to the development of suitable delivery systems and formulations to achieve maximum in vivo potency with minimum potential side effects. These novel formulations-many of which will be nanoparticulates-can deliver the antigens to the desired site, to the relevant antigen presenting cells, and prevent systemic exposure of the immune potentiators. The proposed book will outline all the critical steps that need to be considered for successful development of various types of nanoparticulate delivery systems for vaccine antigens. These contributions from leading experts in the area of vaccine formulation and delivery systems will tie in what is the most current status, including clinical evaluations with these novel vaccine technologies.

This detailed volume provides background on recent new technology developments highlighting the potential of the genomic era in wheat breeding with invaluable instruction on the methodology, which is complemented by overview chapters on the status of new technology application in major wheat production countries. The topics, addressed by internationally renowned scientists active in the field, cover methods underpinning the latest developments in the field of wheat biotechnology. Written for the highly successful Methods in Molecular Biology series, 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. Authoritative and practical, Wheat Biotechnology: Methods and Protocols serves as a vital resource for scientists working to breed future high-yielding wheat varieties to sustain a growing population in an increasingly unpredictable world.

This book presents chemical analyses of our most pressing waste, pollution, and resource problems for the undergraduate or graduate student. The distinctive holistic approach provides both a solid ground in theory, as well as a laboratory manual detailing introductory and advanced experimental applications. The laboratory procedures are presented at microscale conditions, for minimum waste and maximum economy. This work fulfills an urgent need for an introductory text in environmental chemistry combining theory and practice, and is a valuable tool for preparing the next generation of environmental scientists.

This book highlights the proceedings of the International Conference on Atomic, Molecular, Optical and Nano-Physics with Applications (CAMNP 2019), organized by the Department of Applied Physics, Delhi Technological University, New Delhi, India. It presents experimental and theoretical studies of atoms, ions, molecules and nanostructures both at the fundamental level and on the application side using advanced technology. It highlights how modern tools of high-field and ultra-fast physics are no longer merely used to observe nature but can be used to reshape and redirect atoms, molecules, particles or radiation. It brings together leading researchers and professionals on the field to present and discuss the latest finding in the following areas, but not limited to: Atomic and Molecular Structure, Collision Processes, Data Production and Applications Spectroscopy of Solar and Stellar Plasma Intense Field, Short Pulse Laser and Atto-Second Physics Laser Technology, Quantum Optics and applications Bose Einstein condensation Nanomaterials and Nanoscience Nanobiotechnolgy and Nanophotonics Nano and Micro-Electronics Computational Condensed Matter Physics

The book provides an extensive coverage of conjugated polymer based nano-composite coatings with advanced anti-corrosive properties. The book gives detailed explanation of corrosion testing methods and techniques to evaluate the corrosion resistance of the coatings. It includes elaborate discussion on classification of corrosion, electrochemistry of corrosion process, theories explaining the mechanism of corrosion and various corrosion testing standards. Electrochemical studies like open circuit potential (OCP) variation with time, potentiodynamic polarization, Electrochemical Impedance Spectroscopy (EIS) and accelerated corrosion testing are highlighted as important tools to extract information about the behavior of coatings under corrosive conditions. The book discusses epoxy-conjugated polymer based novel composite coating formulations, including aniline and o-toluidine, o-anisidine, phenetidine and pentafluoroaniline with appropriate fillers like SiO2, flyash, ZrO2 nanoparticles, and chitosan for the protection of metallic substrates. A general discussion on the self healing mechanism of epoxy-polypyrrole based biopolymer hybrid composite coatings is included in this book. This book provides a critical review on the conjugated polymer based composite coatings with superior corrosion resistance, good mechanical integrity, better adhesion properties and self healing ability under highly aggressive conditions which can be commercially used for the protection of metal substrates from corrosion.

This book is Volume 2 which is published to complement "Environmental Processes and Management: Tools and Practices" (https://link.springer.com/book/10.1007/978-3-030-38152-3), 2020 This book provides an in-depth, well-researched and science-based approach to applying key project management and spatial tools and practices in environmental projects. This book is an important read for leaders considering projects that balance social-economic growth against minimizing its ill effects on Planet Earth. This book brings together several aspects of groundwater engineering, as well as the formula and analytical approaches required for more informed decision-making. It also highlights the vital importance of understanding the technological, economic and social dimensions of environmental studies explained through dynamic approaches and illustrative figures that have short-term results and long-term impacts. This book emphasizes on encouraging the modern and vibrant research works conducted by young researchers across the world. This book clearly details the general application of fundamental groundwater processes, the character of the different types of systems in which they occur and the way in which these factors influence process dynamics, environmental systems and their possible remedies. The book sets a possible recommendation for the professionalism with which environmental research should be planned, executed, monitored, assessed and delivered. While primarily intended for professionals responsible for the management of groundwater projects or interested in improving the overall efficiency of such projects, it is also useful for managers in the private, public and not-for-profit sectors. The book is a valuable resource for students at both undergraduate and postgraduate levels. In addition, this book serves as an indispensable guide for anyone willing to develop their skills in modern groundwater / environmental management and related techniques

During the upgrading of heavy petroleum, asphaltene is the most problematic impurity since it is the main cause of catalyst deactivation and sediments formation. Exploring many aspects related to asphaltenes composition and conversion, Asphaltenes: Chemical Transformation during Hydroprocessing of Heavy Oils highlights the various changes that these heavy and complex molecules undergo during catalytic hydroprocessing. After defining and characterizing asphaltene structure, the book examines the composition of petroleum and the processes and catalysts for upgrading heavy oils. It then details the characterization of asphaltenes after hydroprocessing and the effect of reaction conditions on their structures. The authors also analyze the deactivation and characterization of spent hydroprocessing catalysts as well as the role played by asphaltenes. They cover sediments formation during hydroprocessing and the role of asphaltenes on it. The final chapters describe the hydrocracking and kinetics of asphaltenes and the fractionation of heavy crudes and asphaltenes. Due to the increasing production of heavy crude oils, asphaltene has become one of the most studied molecules. This book provides a deep understanding of how asphaltenes transform during hydroprocessing, offering insight on designing catalysts and processing for the upgrading of heavy oils.

During the upgrading of heavy petroleum, asphaltene is the most problematic impurity since it is the main cause of catalyst deactivation and sediments formation. Exploring many aspects related to asphaltenes composition and conversion, Asphaltenes: Chemical Transformation during Hydroprocessing of Heavy Oils highlights the various changes that these heavy and complex molecules undergo during catalytic hydroprocessing. After defining and characterizing asphaltene structure, the book examines the composition of petroleum and the processes and catalysts for upgrading heavy oils. It then details the characterization of asphaltenes after hydroprocessing and the effect of reaction conditions on their structures. The authors also analyze the deactivation and characterization of spent hydroprocessing catalysts as well as the role played by asphaltenes. They cover sediments formation during hydroprocessing and the role of asphaltenes on it. The final chapters describe the hydrocracking and kinetics of asphaltenes and the fractionation of heavy crudes and asphaltenes. Due to the increasing production of heavy crude oils, asphaltene has become one of the most studied molecules. This book provides a deep understanding of how asphaltenes transform during hydroprocessing, offering insight on designing catalysts and processing for the upgrading of heavy oils.

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.

Development of new-generation vaccines is now more challenging than ever, as identifying, purifying and evaluating vaccine antigens is a complex undertaking. Most importantly, once the relevant antigens have been identified, key focus then shifts to the development of suitable delivery systems and formulations to achieve maximum in vivo potency with minimum potential side effects. These novel formulations-many of which will be nanoparticulates-can deliver the antigens to the desired site, to the relevant antigen presenting cells, and prevent systemic exposure of the immune potentiators. The proposed book will outline all the critical steps that need to be considered for successful development of various types of nanoparticulate delivery systems for vaccine antigens. These contributions from leading experts in the area of vaccine formulation and delivery systems will tie in what is the most current status, including clinical evaluations with these novel vaccine technologies.

Novel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies takes a look at the current strategies, successes and challenges involved with the development of novel formulations of biologics, vaccines and cancer therapy. This thorough reference on the latest trends in the development of diverse modalities will appeal to a broad community of scientists, students and clinicians. Written by leading authors across academia and industry, this book covers important topics such as unique drug delivery devices, non-parenteral delivery trends, novel approaches to the treatment of cancer, immunotherapy and more. It includes real-world cases and examples which highlight formulations with therapeutic proteins, monoclonal antibodies, peptides and biobetters, as well as cases on novel vaccines formulations including evolving pathogens, novel modalities of vaccines, universal vaccines. This book is a thorough and useful resource on the development of novel biologics, vaccines and cancer therapies.

This book presents chemical analyses of our most pressing waste, pollution, and resource problems for the undergraduate or graduate student. The distinctive holistic approach provides both a solid ground in theory, as well as a laboratory manual detailing introductory and advanced experimental applications. The laboratory procedures are presented at microscale conditions, for minimum waste and maximum economy. This work fulfills an urgent need for an introductory text in environmental chemistry combining theory and practice, and is a valuable tool for preparing the next generation of environmental scientists.

Mahatma Gandhi's humane philosophy and inherent spirituality had a profound influence not only on the people of India but the freedom loving people worldwide. 11th of September 2006 marked the centenary of the Satyagraha movement launched by Mahatma Gandhi in South Africa for peaceful resistance against discriminatory and unjust laws. ""Satyagraha - the firmness of the force Truth"" became a powerful mass movement of peaceful resistance and civil disobedience. Over the years, it evolved into a dynamic mass movement of effective action.Commemorating 100 years of 'Satyagraha' in a befitting manner, the Indian National Congress convened a two day international conference: ""Peace, Non-violence and Empowerment: Gandhian Philosophy in the 21st Century"". Over 300 international delegates from 91 countries comprising world leaders, Nobel laureates, leading peace and human rights activists and Gandhian scholars reflected on the essence and the enduring relevance of Mahatma Gandhi's philosophy. The conference deliberated on subjects and issues which represent the core of Gandhian thought. The discussion touched upon a wide range of Gandhian principles and values including Mahatma Gandhi's concern for the poor and his abiding commitment to non-violence and people's empowerment. Emerging from the discussions amongst the luminaries was the collective affirmation to renew people's commitment to Mahatma's noble mission of building a world that is in peace and harmony with itself.Based on the deliberations of this conference, together with precious archival material, this volume - a book for the future - endeavours to reach out and connect the people, especially the younger generation, to the 'Gandhian way' and to carry forward his legacy into the 21st century.

The book provides an extensive coverage of conjugated polymer based nano-composite coatings with advanced anti-corrosive properties. The book gives detailed explanation of corrosion testing methods and techniques to evaluate the corrosion resistance of the coatings. It includes elaborate discussion on classification of corrosion, electrochemistry of corrosion process, theories explaining the mechanism of corrosion and various corrosion testing standards. Electrochemical studies like open circuit potential (OCP) variation with time, potentiodynamic polarization, Electrochemical Impedance Spectroscopy (EIS) and accelerated corrosion testing are highlighted as important tools to extract information about the behavior of coatings under corrosive conditions. The book discusses epoxy-conjugated polymer based novel composite coating formulations, including aniline and o-toluidine, o-anisidine, phenetidine and pentafluoroaniline with appropriate fillers like SiO2, flyash, ZrO2 nanoparticles, and chitosan for the protection of metallic substrates. A general discussion on the self healing mechanism of epoxy-polypyrrole based biopolymer hybrid composite coatings is included in this book. This book provides a critical review on the conjugated polymer based composite coatings with superior corrosion resistance, good mechanical integrity, better adhesion properties and self healing ability under highly aggressive conditions which can be commercially used for the protection of metal substrates from corrosion.