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The purpose of this book is to give a concise introduction to development and analysis of pharmaceutical biologics for those in the pharmaceutical industry who are switching focus from small molecules to biologics processing, analysis, and delivery. In order to maintain a limited focus, Introduction to Biologic and Biosimilar Product Development and Analysis, will deal only with peptides, proteins and monoclonal antibodies.

This book addresses the highly relevant and complex subject of research on drugs from natural products, discussing the current hot topics in the field. It also provides a detailed overview of the strategies used to research and develop these drugs. Respected experts explore issues involved in the production chain and when looking for new medicinal agents, including aspects such as therapeutic potential, functional foods, ethnopharmacology, metabolomics, virtual screening and regulatory scenarios. Further, the book describes strategic methods of isolation and characterization of active principles, biological assays, biotechnology of plants, synthesis, clinical trials and the use of tools to identity active principles.

This thesis addresses fundamental scientific questions such as:How are complex natural products synthesized in vivo?Can we replicate these conditions in a laboratory environment?What is the biological function of such secondary metabolites?What are the biological origins of chirality?These issues are explored in an accessible manner using a multidisciplinary approach spanning chemistry, biology and physics to investigate an interesting family of complex natural products isolated from marine molluscs – the tridachiahydropyrones.The work has achieved:Elegant biomimetic syntheses of a number of the tridachiahydropyrone compounds in vitro using organic synthesis techniquesThe characterization of the interactions between these compounds and a range of model membrane systems using a series of fluorescence spectroscopic studiesThe investigation of the antioxidant and photoprotective properties of the compounds by means of biophysical assay techniquesThe synthesis of tridachiahydropyrone utilizing the model membrane systems as biomimetic reaction media.

Volumes are organized topically and provide a comprehensive discussion of developments in the respective field over the past 3-5 years. The series also discusses new discoveries and applications. Special volumes are dedicated to selected topics which focus on new biotechnological products and new processes for their synthesis and purification. In general, special volumes are edited by well-known guest editors. The series editor and publisher will however always be pleased to receive suggestions and supplementary information. Manuscripts are accepted in English.

Martin Stein's thesis describes a novel methodology for natural product discovery. Due to its high degree of reproducibility, robustness and sensitivity, the technique can be utilized to detect even trace amounts of bioactive substances in heterogeneous matrices such as fermentation broths or crude organic extracts. This research is thus relevant for a large number of researchers working in natural product discovery. Applications of this novel NMR-based approach include suitable environmental triggers for the induction of biosynthetic machineries. The author demonstrates the extraordinary value of this approach by the successful isolation of two potent inhibitors of the pharmaceutically relevant proteasome core particle from the insect pathogen photorhabdus luminescens. This thesis has led to a number of publications in high-impact journals.

Biologics have revolutionised the treatment of many severe conditions, delivering exceptional clinical results but also producing exceptionally high prices. As patents expire, copies and price competition are expected throughout the world. However, due to the intrinsic heterogeneity and molecular complexity of biologic medicinal products, their copies cannot simply be authorized under the “generic rule” valid for small chemical entities. In response, a dedicated regulation was issued in the European Union. It is based on the concept of “biological medicinal products similar to a biological reference product”, or “biosimilars”. This book analyses the context of biotechnological production and addresses the European legal framework for biosimilar market approval. It highlights post-market authorisation issues, such as Risk Management Plans and substitution of products, and outlines some other issues, such as cost management and international nomenclature. This book is primarily intended for hospital-based physicians and pharmacists. It will also be a valuable resource for all actors from all countries who want to better understand the emergence of these new medicinal products within the European context.

This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)

This work presents a definitive interpretation of the current status of and future trends in natural products—a dynamic field at the intersection of chemistry and biology concerned with isolation, identification, structure elucidation, and chemical characteristics of naturally occurring compounds such as pheromones, carbohydrates, nucleic acids, and enzymes. With more than 1,800 color figures, Comprehensive Natural Products II features 100% new material and complements rather than replaces the original work (©1999). - Reviews the accumulated efforts of chemical and biological research to understand living organisms and their distinctive effects on health and medicine - Stimulates new ideas among the established natural products research community—which includes chemists, biochemists, biologists, botanists, and pharmacologists - Informs and inspires students and newcomers to the field with accessible content in a range of delivery formats - Includes 100% new content, with more than 6,000 figures (1/3 of these in color) and 40,000 references to the primary literature, for a thorough examination of the field - Highlights new research and innovations concerning living organisms and their distinctive role in our understanding and improvement of human health, genomics, ecology/environment, and more - Adds to the rich body of work that is the first edition, which will be available for the first time in a convenient online format giving researchers complete access to authoritative Natural Products content

Natural products present in the plant and animal kingdom offer a huge diversity of chemical structures which are the result of biosynthetic processes that have been modulated over the millennia through genetic effects. With the rapid developments in spectroscopic techniques and accompanying advances in high-throughput screening techniques, it has become possible to isolate, determine the structures and biological activity of natural products rapidly, thus opening up exciting new opportunities in the field of new drug development to the pharmaceutical industry. The present volume contains 22 articles written by leading experts in natural product chemistry on biologically active natural products. It includes research on a variety of different classes of natural products including sesquiterpenes, quassinoids, diterpenoids, lignans, oligostilbenes, phenylethanoids, phenylpropanoid glycosides, curcumin analogues, glycosphingolipids etc. Many of these have been found to be active in a number of different disease conditions.• Timely reviews written by international authorities in the field• Topics ranging from purely chemical to very biological• The 13th volume in the series to be devoted to bioactive natural products

Bioactive Marine Natural Products is the first book available that covers all aspects of bioactive marine natural products. It fills the void in the literature for bioactive marine natural products. The book covers various aspects of marine natural products and it is hoped that all the major classes of bioactive compounds are included. Different classes of marine organisms and the separation and isolation techniques are discussed. The chemistry and biology of marine toxins, peptides, alkaloids, nucleosides and prostanoids are discussed in detail. Biological, toxicological and clinical evaluations are also dealt with to ensure that the book may be adopted at any stage by any practicing organic chemist or biologist, working in academia or in R and D divisions of pharmaceutical companies. Each chapter in the book includes an abstract to highlight the major points discussed in the text and concluding remarks are given. References to books, monographs, review articles and original papers are provided at the end of each chapter.

The Studies in Natural Products Chemistry series is a valuable source for researchers and engineers working in natural product and medicinal chemistry. Studies in Natural Products Chemistry Volume 31: Indices Part A encompasses the contents of the previous 30 volumes published in the Studies in Natural Products series. To make searching easier, the book is divided into four separate indices: Cumulative General Subject Index; Cumulative Organic Synthesis Index; Cumulative Pharmacological Activity Index and; Cumulative Biological Source Index, allowing readers to easily locate required information. This volume and the series remain an important addition to any library.• Encompasses the contents of the previous 30 volumes published in the Studies in Natural Products series • The book is divided into four separate indices: Cumulative General Subject Index; Cumulative Organic Synthesis Index; Cumulative Pharmacological Activity Index and; Cumulative Biological Source Index • An important addition to any library

Specialist Periodical Reports provide systematic and detailed review coverage of progress in the major areas of chemical research. Written by experts in their specialist fields the series creates a unique service for the active research chemist, supplying regular critical in-depth accounts of progress in particular areas of chemistry. For over 80 years the Royal Society of Chemistry and its predecessor, the Chemical Society, have been publishing reports charting developments in chemistry, which originally took the form of Annual Reports. However, by 1967 the whole spectrum of chemistry could no longer be contained within one volume and the series Specialist Periodical Reports was born. The Annual Reports themselves still existed but were divided into two, and subsequently three, volumes covering Inorganic, Organic and Physical Chemistry. For more general coverage of the highlights in chemistry they remain a'must'. Since that time the SPR series has altered according to the fluctuating degree of activity in various fields of chemistry. Some titles have remained unchanged, while others have altered their emphasis along with their titles; some have been combined under a new name whereas others have had to be discontinued. The current list of Specialist Periodical Reports can be seen on the inside flap of this volume.

Specialist Periodical Reports provide systematic and detailed review coverage of progress in the major areas of chemical research. Written by experts in their specialist fields the series creates a unique service for the active research chemist, supplying regular critical in-depth accounts of progress in particular areas of chemistry. For over 80 years the Royal Society of Chemistry and its predecessor, the Chemical Society, have been publishing reports charting developments in chemistry, which originally took the form of Annual Reports. However, by 1967 the whole spectrum of chemistry could no longer be contained within one volume and the series Specialist Periodical Reports was born. The Annual Reports themselves still existed but were divided into two, and subsequently three, volumes covering Inorganic, Organic and Physical Chemistry. For more general coverage of the highlights in chemistry they remain a'must'. Since that time the SPR series has altered according to the fluctuating degree of activity in various fields of chemistry. Some titles have remained unchanged, while others have altered their emphasis along with their titles; some have been combined under a new name whereas others have had to be discontinued.