Recombinant Protein Drugs

Therefore, this book represents an exciting documentation of the beginning of a new era in the pharmaceutical industry. In addition, scientists from basic research, clinic and industry actively involved in new developments discuss.

Recombinant Protein Drugs

Recombinant protein drugs are intimately associated with the impressive success story of the Biotech Industry during the past thirty years, some of them belonging to the most successful pharmaceutical products. More than thirty different proteins are available for a variety of clinical applications, over 300 proteins are presently being evaluated in clinical trials. In this new volume of the MDT series, historical, technical and clinical aspects of recombinant protein drug discovery and development are presented, covering past, present and future highlights. Leading scientists and co-founders of early Biotech companies describe technical breakthroughs and the fascinating story of pioneering discoveries, as well as the long way of translating them into products and business. Therefore, this book represents an exciting documentation of the beginning of a new era in the pharmaceutical industry. In addition, scientists from basic research, clinic and industry actively involved in new developments discuss...

Interferon The Dawn of Recombinant Protein Drugs

Let us go back more than 40 years. In 1956 Isaacs was in charge of the Wodd Influenza Centre. Andrewes was head of the division of bac teriology and virology, and deputy director of the National Institute for Medical Research in London.

Interferon  The Dawn of Recombinant Protein Drugs

Forty years of Interferon I wish to dedicate this short introduction to the memory of Alick Isaacs (1921-1967), and to that of Sir Christopher Andrewes (1896-1988). Let us go back more than 40 years. In 1956 Isaacs was in charge of the Wodd Influenza Centre. Andrewes was head of the division of bac teriology and virology, and deputy director of the National Institute for Medical Research in London. When researchers are faced with a seemingly new phenomenon, ex planations are easy to come by. These explanations fall into two broad categories: the phenomenon in question is either due to something or to the lack of something. I apologize for the primitive way in which I ex press this, but I am going to give three examples, scattered over 100 years, of what I mean. First example: in 1880 the great French microbiologist Louis Pas teur was involved in work on chicken cholera. He was struck by the following observation: if a suitable chicken broth was inoculated with the bacterium, the organism grew profusely and the liquid became tur bid. If he now freed the fluid, by sedimentation or filtration, from the bulk of the organisms and re-inoculated it with the same bacterium, no growth occurred.

Therapeutic Proteins

This volume contains contributions from leaders in the field of therapeutic protein expression, purification, characterization, f- mulation, and viral inactivation.

Therapeutic Proteins

With the recent completion of the sequencing of the human genome, it is widely anticipated that the number of potential new protein drugs and targets will escalate at an even greater rate than that observed in recent years. However, identification of a potential target is only part of the process in developing these new next generation protein-based “drugs” that are increasingly being used to treat human disease. Once a potential protein drug has been identified, the next rate-limiting step on the road to development is the production of sufficient authentic material for testing, charact- ization, clinical trials, and so on. If a protein drug does actually make it through this lengthy and costly process, methodology that allows the production of the protein on a scale large enough to meet demand must be implemented. Furthermore, large-scale production must not compromise the authenticity of the final product. It is also nec- sary to have robust methods for the purification, characterization, viral inactivation and continued testing of the authenticity of the final protein product and to be able to formulate it in a manner that retains both its biological activity and lends itself to easy administration. Therapeutic Proteins: Methods and Protocols covers all aspects of protein drug production downstream of the discovery stage. This volume contains contributions from leaders in the field of therapeutic protein expression, purification, characterization, f- mulation, and viral inactivation.

Interferon The Dawn of Recombinant Protein Drugs

The transformation of interleukin-2 into a drug is also related to the loss of its status as a “different” cure for ... in the status of cytokines is reflected in the subtitle of this symposium: “the dawn of recombinant protein drugs”.

Interferon  The Dawn of Recombinant Protein Drugs

Forty years of Interferon I wish to dedicate this short introduction to the memory of Alick Isaacs (1921-1967), and to that of Sir Christopher Andrewes (1896-1988). Let us go back more than 40 years. In 1956 Isaacs was in charge of the Wodd Influenza Centre. Andrewes was head of the division of bac teriology and virology, and deputy director of the National Institute for Medical Research in London. When researchers are faced with a seemingly new phenomenon, ex planations are easy to come by. These explanations fall into two broad categories: the phenomenon in question is either due to something or to the lack of something. I apologize for the primitive way in which I ex press this, but I am going to give three examples, scattered over 100 years, of what I mean. First example: in 1880 the great French microbiologist Louis Pas teur was involved in work on chicken cholera. He was struck by the following observation: if a suitable chicken broth was inoculated with the bacterium, the organism grew profusely and the liquid became tur bid. If he now freed the fluid, by sedimentation or filtration, from the bulk of the organisms and re-inoculated it with the same bacterium, no growth occurred.

Cell Culture Engineering

Since the introduction of recombinant human growth hormone and insulin a quarter century ago, protein therapeutics has greatly broadened the ho- zon of health care.

Cell Culture Engineering

Since the introduction of recombinant human growth hormone and insulin a quarter century ago, protein therapeutics has greatly broadened the ho- zon of health care. Many patients suffering with life-threatening diseases or chronic dysfunctions, which were medically untreatable not long ago, can attest to the wonder these drugs have achieved. Although the ?rst generation of p- tein therapeutics was produced in recombinant Escherichia coli, most recent products use mammalian cells as production hosts. Not long after the ?rst p- duction of recombinant proteins in E. coli, it was realized that the complex tasks of most post-translational modi?cations on proteins could only be ef?ciently carried out in mammalian cells. In the 1990s, we witnessed a rapid expansion of mammalian-cell-derived protein therapeutics, chie?y antibodies. In fact, it has been nearly a decade since the market value of mammalian-cell-derived protein therapeutics surpassed that of those produced from E. coli. A common characteristic of recent antibody products is the relatively large dose required for effective therapy, demanding larger quantities for the treatment of a given disease. This, coupled with the broadening repertoire of protein drugs, has rapidly expanded the quantity needed for clinical applications. The increasing demand for protein therapeutics has not been met exclusively by construction of new manufacturing plants and increasing total volume capacity. More - portantly the productivity of cell culture processes has been driven upward by an order of magnitude in the past decade.

Interferon The Dawn of Recombinant Protein Drugs

Let us go back more than 40 years. In 1956 Isaacs was in charge of the Wodd Influenza Centre. Andrewes was head of the division of bac teriology and virology, and deputy director of the National Institute for Medical Research in London.

Interferon  The Dawn of Recombinant Protein Drugs

Forty years of Interferon I wish to dedicate this short introduction to the memory of Alick Isaacs (1921-1967), and to that of Sir Christopher Andrewes (1896-1988). Let us go back more than 40 years. In 1956 Isaacs was in charge of the Wodd Influenza Centre. Andrewes was head of the division of bac teriology and virology, and deputy director of the National Institute for Medical Research in London. When researchers are faced with a seemingly new phenomenon, ex planations are easy to come by. These explanations fall into two broad categories: the phenomenon in question is either due to something or to the lack of something. I apologize for the primitive way in which I ex press this, but I am going to give three examples, scattered over 100 years, of what I mean. First example: in 1880 the great French microbiologist Louis Pas teur was involved in work on chicken cholera. He was struck by the following observation: if a suitable chicken broth was inoculated with the bacterium, the organism grew profusely and the liquid became tur bid. If he now freed the fluid, by sedimentation or filtration, from the bulk of the organisms and re-inoculated it with the same bacterium, no growth occurred.

Biotechnology and Biopharmaceuticals

The essential single source on drug discovery and biotechnology products newly revised and updated Since the first edition of Biotechnology and Biopharmaceuticals was published, biotechnology has continued to drive therapeutic product ...

Biotechnology and Biopharmaceuticals

Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.

Introduction to Biological and Small Molecule Drug Research and Development

Throughout human history, the morbidity and mortality associated with human disease has driven medical science into an ever-expanding quest for treatment and cure.

Introduction to Biological and Small Molecule Drug Research and Development

Throughout human history, the morbidity and mortality associated with human disease has driven medical science into an ever-expanding quest for treatment and cure. Over the past century, a therapeutic approach complementing chemical drugs has been developing which uses proteins and peptides in the treatment of disease. Many innovative protein therapeutic platforms are currently being employed and continue to be developed to attain cures in areas of unmet medical need; these include direct copies of natural protein structure and function as well as proteins with completely novel functionality. Today, protein therapeutics represents the fastest growing sector in the pharmaceutical industry and comprises 16% of prescription drug sales in 2011.

Therapeutic Peptides and Proteins

Upon publication of the first edition of Therapeutic Peptides and Proteins ten years ago there were only 19 biotechology medicines on the market.

Therapeutic Peptides and Proteins

Upon publication of the first edition of Therapeutic Peptides and Proteins ten years ago there were only 19 biotechology medicines on the market. Currently there are more than 100, with at least 400 more in various stages of development. That alone would be grounds for a new edition. Add to that the fact that it is still difficult to find up

Excipient Development for Pharmaceutical Biotechnology and Drug Delivery Systems

Along with the scientific and technical advances in the production of recombinant proteins, the principal reason for the success of protein drugs is their high specificity towards targets and superior safety profiles when compared to ...

Excipient Development for Pharmaceutical  Biotechnology  and Drug Delivery Systems

To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new excipients to be developed and approved continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge new avenue

Formulation Characterization and Stability of Protein Drugs

An invaluable aid in the rapid identification of potential `hot spots' in proteins, this accessible compilation allows for inspection of the protein's primary structure and preparation of a hydroflex plot.

Formulation  Characterization  and Stability of Protein Drugs

Leading scientists offer detailed profiles of ten protein drugs currently in development. The case histories of these important new compounds are described from the perspective of their formulation, characterization, and stability. This ready reference also features recent data and an abundance of previously unpublished information. The in-depth coverage includes a highly useful compendium of degradation sites occurring in over 70 proteins. An invaluable aid in the rapid identification of potential `hot spots' in proteins, this accessible compilation allows for inspection of the protein's primary structure and preparation of a hydroflex plot.

Biological Barriers to Protein Delivery

In response to the tremendous increase in the number of protein and peptide drugs, this treatise critically reviews transport and metabolism mechanisms relating to the delivery of endogenous and recombinant proteins to mammalian organs, ...

Biological Barriers to Protein Delivery

In response to the tremendous increase in the number of protein and peptide drugs, this treatise critically reviews transport and metabolism mechanisms relating to the delivery of endogenous and recombinant proteins to mammalian organs, tissues, and cells. It will promote fruitful collaboration among academic and industrial scientists in the fields of pharmacology, cell biology, biochemistry, physiology, and immunology.

Protein Therapeutics

Therefore, the topic-related series Topics in Medicinal Chemistry covers all relevant aspects of drug research, e.g. pathobiochemistry of diseases, identification and validation of (emerging) drug targets, structural biology, drugability of ...

Protein Therapeutics

Medicinal chemistry is both science and art. The science of medicinal chemistry offers mankind one of its best hopes for improving the quality of life. The art of medicinal chemistry continues to challenge its practitioners with the need for both intuition and experience to discover new drugs. Hence sharing the experience of drug research is uniquely beneficial to the field of medicinal chemistry. Drug research requires interdisciplinary team-work at the interface between chemistry, biology and medicine. Therefore, the topic-related series Topics in Medicinal Chemistry covers all relevant aspects of drug research, e.g. pathobiochemistry of diseases, identification and validation of (emerging) drug targets, structural biology, drugability of targets, drug design approaches, chemogenomics, synthetic chemistry including combinatorial methods, bioorganic chemistry, natural compounds, high-throughput screening, pharmacological in vitro and in vivo investigations, drug-receptor interactions on the molecular level, structure-activity relationships, drug absorption, distribution, metabolism, elimination, toxicology and pharmacogenomics. In general, special volumes are edited by well known guest editors

Cell Culture Engineering

Since the introduction of recombinant human growth hormone and insulin a quarter century ago, protein therapeutics has greatly broadened the ho- zon of health care.

Cell Culture Engineering

Since the introduction of recombinant human growth hormone and insulin a quarter century ago, protein therapeutics has greatly broadened the ho- zon of health care. Many patients suffering with life-threatening diseases or chronic dysfunctions, which were medically untreatable not long ago, can attest to the wonder these drugs have achieved. Although the ?rst generation of p- tein therapeutics was produced in recombinant Escherichia coli, most recent products use mammalian cells as production hosts. Not long after the ?rst p- duction of recombinant proteins in E. coli, it was realized that the complex tasks of most post-translational modi?cations on proteins could only be ef?ciently carried out in mammalian cells. In the 1990s, we witnessed a rapid expansion of mammalian-cell-derived protein therapeutics, chie?y antibodies. In fact, it has been nearly a decade since the market value of mammalian-cell-derived protein therapeutics surpassed that of those produced from E. coli. A common characteristic of recent antibody products is the relatively large dose required for effective therapy, demanding larger quantities for the treatment of a given disease. This, coupled with the broadening repertoire of protein drugs, has rapidly expanded the quantity needed for clinical applications. The increasing demand for protein therapeutics has not been met exclusively by construction of new manufacturing plants and increasing total volume capacity. More - portantly the productivity of cell culture processes has been driven upward by an order of magnitude in the past decade.

Peptide and Protein Drug Analysis

Protein and peptide C - terminal sequence analyses can be used to determine the precise processing sites . In the case of rat stem cell factor ( SCF ) produced naturally ( 132 ) or recombinant human SCF produced in Chinese hamster ovary ...

Peptide and Protein Drug Analysis

Furthering efforts to simulate the potency and specificity exhibited by peptides and proteins in healthy cells, this remarkable reference supplies pharmaceutical scientists with a wealth of techniques for tapping the enormous therapeutic potential of these molecules-providing a solid basis of knowledge for new drug design. Provides a broad, comprehensive overview of peptides and proteins as mediators of cell movement, proliferation, differentiation, and communication. Written by more than 50 leading international authorities, Peptides and Protein Drug Analysis discusses strategies for dealing with the complexity of peptides and proteins in conformational flexibility and amino acid sequence variability analyzes drug formulations facilitated by solid-phase peptide synthesis and recombinant DNA technology examines chemical purity analysis by high-pressure chromatographic, capillary electrophoretic, gel electrophoretic, and isoelectric focusing methods highlights drug design elements derived from protein folding, bioinformatics, and computational chemistry demonstrates uses of unnatural mutagenesis and combinatorial chemistry explores mass spectrometry, protein sequence, and carbohydrate analysis illustrates bioassays and other new functional analysis methods surveys spectroscopic techniques such as ultraviolet, fluorescence, Fourier transform infrared, and nuclear magnetic resonance (NMR) addresses ways of distinguishing between levels of therapeutic and endogenous agents in cells reviews structural analysis tools such as ultracentrifugation and light, X-ray, and neutron scattering and more! Featuring over 3400 bibliographic citations and more than 500 tables, equations, and illustrations, Peptide and Protein Drug Analysis is a must-read resource for pharmacists; pharmacologists; analytical, organic, and pharmaceutical chemists; cell and molecular biologists; biochemists; and upper-level undergraduate and graduate students in these disciplines.

Analytical Methods for Studying the Stability of Protein Molecules

In this book we establish the HPLC methods for analysis of lenograstim and the products resulting from the chemical and physical instability of its molecule.

Analytical Methods for Studying the Stability of Protein Molecules

During the past two decades, recombinant DNA technology brought about a significant increase in the number of protein drugs. The development of analytical techniques enables a high degree of clarification of the recombinant proteins, which in turn, brings about a significant decrease of the adverse effects. In spite of that, one of the capital problems, and challenges in the development of protein pharmaceuticals remains unsolved: the physical and chemical instability/degradation of proteins, which is in close connection with the appearance of toxicity through the stimulation of immune and/or allergic reactions, only to result with a decrease or a complete loss of the biological activity in the end. In this book we establish the HPLC methods for analysis of lenograstim and the products resulting from the chemical and physical instability of its molecule. These methods allow for the detection of the oxidized forms and aggregates of lenograstim at the very beginning of their formation that would signalize any changes in the stability of the molecule. The book would be of great value for scientists and practitioners working in research, development and production of protein drugs.

Fusion Protein Technologies for Biopharmaceuticals

The book covers the major types of fusion proteins—receptor-traps, immunotoxins, Fc-fusions and peptibodies—while also detailing the approaches for developing, delivering, and improving the stability of fusion proteins.

Fusion Protein Technologies for Biopharmaceuticals

The state of the art in biopharmaceutical FUSION PROTEINDESIGN Fusion proteins belong to the most lucrative biotechdrugs—with Enbrel® being one of the best-sellingbiologics worldwide. Enbrel® represents a milestone of moderntherapies just as Humulin®, the first therapeutic recombinantprotein for human use, approved by the FDA in 1982 andOrthoclone® the first monoclonal antibody reaching the marketin 1986. These first generation molecules were soon followed by aplethora of recombinant copies of natural human proteins, and in1998, the first de novo designed fusion protein was launched. Fusion Protein Technologies for Biopharmaceuticalsexamines the state of the art in developing fusion proteins forbiopharmaceuticals, shedding light on the immense potentialinherent in fusion protein design and functionality. A widepantheon of international scientists and researchers deliver acomprehensive and complete overview of therapeutic fusion proteins,combining the success stories of marketed drugs with the dynamicpreclinical and clinical research into novel drugs designed for asyet unmet medical needs. The book covers the major types of fusionproteins—receptor-traps, immunotoxins, Fc-fusions andpeptibodies—while also detailing the approaches fordeveloping, delivering, and improving the stability of fusionproteins. The main body of the book contains three large sectionsthat address issues key to this specialty: strategies for extendingthe plasma half life, the design of toxic proteins, and utilizingfusion proteins for ultra specific targeting. The book concludeswith novel concepts in this field, including examples of highlyrelevant multifunctional antibodies. Detailing the innovative science, commercial realities, andbrilliant potential of fusion protein therapeutics, FusionProtein Technologies for Biopharmaceuticals is a must forpharmaceutical scientists, biochemists, medicinal chemists,molecular biologists, pharmacologists, and genetic engineersinterested in determining the shape of innovation in the world ofbiopharmaceuticals.

Stability and Characterization of Protein and Peptide Drugs

This is the first volume to make available specific case histories of therapeutic proteins and peptides that have been marketed or are currently under clinical testing.

Stability and Characterization of Protein and Peptide Drugs

This is the first volume to make available specific case histories of therapeutic proteins and peptides that have been marketed or are currently under clinical testing. The editors have selected a wide range of molecules derived from monoclonal antibodies, recombinant DNA, and natural and chemical sources to provide formulation scientists with practical examples of the deveopment of pharmaceutical products.

Rational Design of Stable Protein Formulations

This book describes the current level of understanding of protein instability and the strategies for stabilizing proteins under a variety of stressful conditions.

Rational Design of Stable Protein Formulations

Recombinant proteins and polypeptides continue to be the most important class of biotechnology-derived agents in today's pharmaceutical industry. Over the past few years, our fundamental understanding of how proteins degrade and how stabilizing agents work has made it possible to approach formulation of protein pharmaceuticals from a much more rational point of view. This book describes the current level of understanding of protein instability and the strategies for stabilizing proteins under a variety of stressful conditions.

Polypeptide Protein Drugs

A review of recent developments in polypeptide and protein chemistry and biology relevant to their exploitation as pharmaceuticals.

Polypeptide Protein Drugs

A review of recent developments in polypeptide and protein chemistry and biology relevant to their exploitation as pharmaceuticals. Topics covered include the structure and folding of proteins, polypeptide function, the current status of polypeptide pharmaceuticals, quality control and safety.