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Therapeutic Protein Drug Products

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Therapeutic Protein Drug Products

Therapeutic Protein Drug Products Book
Author : Brian K Meyer
Publisher : Elsevier
Release : 2012-01-02
ISBN : 1908818107
Language : En, Es, Fr & De

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Book Description :

Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches. A brief section on biophysical and analytical analysis is also provided. Properties of therapeutic protein formulations are described and include opalescence, phase separation, color, and subvisible particles. An emphasis is placed on material and process testing to ensure success during manufacturing. The drug product manufacturing process, which includes the process of compounding to filling, is also covered. Methods of delivery in the clinic are addressed, as well as delivery strategies. Finally, a perspective on the regulatory requirements for therapeutic protein formulations is discussed. Provides a list and description of commercially available therapeutic drug products and their formulations A comprehensive and practical overview of protein formulation in the laboratory, manufacturing, and the clinic Discusses recent topics including high protein concentration, phase separation, opalescence, and subvisible particles

Aggregation of Therapeutic Proteins

Aggregation of Therapeutic Proteins Book
Author : Wei Wang,Christopher J. Roberts
Publisher : John Wiley & Sons
Release : 2010-12-28
ISBN : 9781118043585
Language : En, Es, Fr & De

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Book Description :

This book gives pharmaceutical scientists an up-to-date resource on protein aggregation and its consequences, and available methods to control or slow down the aggregation process. While significant progress has been made in the past decade, the current understanding of protein aggregation and its consequences is still immature. Prevention or even moderate inhibition of protein aggregation has been mostly experimental. The knowledge in this book can greatly help pharmaceutical scientists in the development of therapeutic proteins, and also instigate further scientific investigations in this area. This book fills such a need by providing an overview on the causes, consequences, characterization, and control of the aggregation of therapeutic proteins.

Biophysics for Therapeutic Protein Development

Biophysics for Therapeutic Protein Development Book
Author : Linda O. Narhi
Publisher : Springer Science & Business Media
Release : 2013-02-26
ISBN : 1461443164
Language : En, Es, Fr & De

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Book Description :

This book can be used to provide insight into this important application of biophysics for those who are planning a career in protein therapeutic development, and for those outside this area who are interested in understanding it better. The initial chapters describe the underlying theory, and strengths and weaknesses of the different techniques commonly used during therapeutic development. The majority of the chapters discuss the applications of these techniques, including case studies, across the product lifecycle from early discovery, where the focus is on identifying targets, and screening for potential drug product candidates, through expression and purification, large scale production, formulation development, lot-to-lot comparability studies, and commercial support including investigations.

Therapeutic Proteins

Therapeutic Proteins Book
Author : Vladimir Voynov,Justin A. Caravella
Publisher : Humana Press
Release : 2016-05-01
ISBN : 9781493959495
Language : En, Es, Fr & De

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Book Description :

Emphasizing the newest developments in the field, this volume presents detailed methodswith added emphasison therapeutic protein discovery. It features key tips and valuable implementation advice to ensure successful results."

Therapeutic Proteins

Therapeutic Proteins Book
Author : C. Mark Smales,David C. James
Publisher : Springer Science & Business Media
Release : 2008-02-04
ISBN : 1592599222
Language : En, Es, Fr & De

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Book Description :

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.

Particles in Therapeutic Protein Formulations

Particles in Therapeutic Protein Formulations Book
Author : Pinaki Basu
Publisher : Unknown
Release : 2014
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Therapeutic protein drug products are used in the treatment and mitigation of human diseases for which no or very few alternative therapies are available e.g. Factor VIII, insulin, erythropoietin, interferon alpha, bevacizumab, etanercept etc. Siliconized prefilled syringes are often utilized as a primary container for therapeutic protein drug products. Despite efforts to maintain high product quality, the formation of unwanted particles is occasionally observed in therapeutic protein formulations in siliconized prefilled syringes. During the last few years, interest in sub-visible particles in therapeutic protein drug products has significantly increased due to its potential of eliciting an adverse immunogenic response. Consequently, evaluating the source and level of sub-visible particles in therapeutic protein drug products is important. In the studies that comprise my thesis, it was found that agitation of therapeutic protein formulations in the presence of siliconized beads accelerated the formation of sub-visible particles. Perturbation of the tertiary structure of therapeutic protein resulted from adsorption at the silicone oil-water interface. The addition of excipients, such as sucrose and sodium chloride, reduced tertiary structural changes. Lastly we found that rupturing the therapeutic protein layer at the air-water or silicone oil-water interface(s) accelerated the formation of sub-visible particles in therapeutic protein formulations. Overall, the work described in this thesis demonstrates that assessment of sub-visible particles in therapeutic protein formulations advances our understanding of therapeutic protein stability in the presence of silicone oil droplets/siliconized interfaces.

Pharmaceutical Formulation Development of Peptides and Proteins Second Edition

Pharmaceutical Formulation Development of Peptides and Proteins  Second Edition Book
Author : Lars Hovgaard,Sven Frokjaer,Marco van de Weert
Publisher : CRC Press
Release : 2012-11-14
ISBN : 1439853886
Language : En, Es, Fr & De

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Book Description :

The rapid advances in recombinant DNA technology and the increasing availability of peptides and proteins with therapeutic potential are a challenge for pharmaceutical scientists who have to formulate these compounds as drug products. Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition discusses the development of therapeutic peptides and proteins, from the production of active compounds via basic pre-formulation and formulation to the registration of the final product. Providing integrated solutions, this book discusses: The synthesis of peptides and the biotechnological production of proteins through recombinant DNA technology The physicochemical characteristics and stability of peptides and proteins The formulation of proteins as suspensions, solutions, and (mostly freeze-dried) solids The opportunities and challenges of non-parenteral delivery of peptides and proteins Risk factors, specifically the development of an unwanted immune response A simulation approach to describe the fate of peptides and proteins upon administration to a biological system The documentation required to register a protein-based drug Scientists in the pharmaceutical industry and academia as well as postgraduate students in pharmaceutical science will find this a valuable resource.

Protein Therapeutics 2 Volume Set

Protein Therapeutics  2 Volume Set Book
Author : Tristan Vaughan,Jane Osbourn,Bahija Jallal,Raimund Mannhold,Gerd Folkers,Helmut Buschmann
Publisher : John Wiley & Sons
Release : 2017-12-04
ISBN : 3527340866
Language : En, Es, Fr & De

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Book Description :

In this practice-oriented handbook, professionals from some of the largest biopharmaceutical companies and top academic researchers address the key concepts and challenges in the development of protein pharmaceuticals for medicinal chemists and other professionals working in drug development. Following an introduction tracing the rapid development of the protein therapeutics market over the last decade, all currently used therapeutic protein scaffolds are surveyed, from human and non-human antibodies to antibody mimetics, bispecific antibodies and antibody-drug conjugates. This ready reference then goes on to review other key aspects such as pharmacokinetics, safety and immunogenicity, manufacture, formulation and delivery. The handbook then takes a look at current key clinical applications for protein therapeutics, from respiratory and inflammation to oncology and immune-oncology, infectious diseases and rescue therapy. Finally, several exciting prospects for the future of protein therapeutics are highlighted and discussed.

Monoclonal Antibodies

Monoclonal Antibodies Book
Author : Steven Shire
Publisher : Woodhead Publishing
Release : 2015-04-24
ISBN : 0081002971
Language : En, Es, Fr & De

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Book Description :

Monoclonal antibodies (MAbs) are currently the major class of protein bio therapeutic being developed by biotechnology and pharmaceutical companies. Monoclonal Antibodies discusses the challenges and issues revolving around development of a monoclonal antibody produced by recombinant DNA technology into a therapeutic agent.This book covers downstream processing which includes design of processes to manufacture the formulation, formulation design, fill and finish into closure systems and routes of administration. The characterization of the final drug product is covered where the use of biophysical methods combined with genetic engineering is used to understand the solution properties of the formulation. The latter has become very important since many indications such as arthritis and asthma require the development of formulations for subcutaneous delivery (SC). The development of formulations for IV delivery is also important and comes with a different set of challenges. The challenges and strategies that can overcome these limitations are discussed in this book, starting with an introduction to these issues, followed by chapters detailing strategies to deal with them. Subsequent chapters explore the processing and storage of mAbs, development of delivery device technologies and conclude with a chapter on the future of mAbs in therapeutic remedies. Discusses the challenges to develop MAbs for intravenous (IV) and subcutaneous delivery (SC) Presents strategies to meet the challenges in development of MAbs for SC and IV administration Discusses the use of biophysical analytical tools coupled with MAb engineering to understand what governs MAb properties at high concentration

Peptide and Protein Delivery

Peptide and Protein Delivery Book
Author : Chris Van Der Walle
Publisher : Academic Press
Release : 2011-05-12
ISBN : 9780123849366
Language : En, Es, Fr & De

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Book Description :

The growing area of peptide and protein therapeutics research is of paramount importance to medical application and advancement. A needed reference for entry level researchers and researchers working in interdisciplinary / collaborative projects, Peptide and Protein Delivery addresses the current and emerging routes for delivery of therapeutics. Covering cerebral delivery, pulmonary delivery, transdermal delivery, intestinal delivery, ocular delivery, parenteral delivery, and nasal delivery, this resource offers an overview of the main routes in therapeutics. Researchers across biochemistry, pharmaceutical, molecular biology, cell biology, immunology, chemistry and biotechnology fields will find this publication invaluable for peptide and protein laboratory research. Discusses the most recent data, ideas and concepts Presents case studies and an industrial perspective Details information from the molecular level to bioprocessing Thought provoking, for the novice to the specialist Timely, for today's biopharmaceuticals market

ADME and Translational Pharmacokinetics Pharmacodynamics of Therapeutic Proteins

ADME and Translational Pharmacokinetics   Pharmacodynamics of Therapeutic Proteins Book
Author : Honghui Zhou,Frank-Peter Theil
Publisher : John Wiley & Sons
Release : 2015-10-26
ISBN : 111889880X
Language : En, Es, Fr & De

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Book Description :

With an emphasis on the fundamental and practical aspects of ADME for therapeutic proteins, this book helps readers strategize, plan and implement translational research for biologic drugs. • Details cutting-edge ADME (absorption, distribution, metabolism and excretion) and PKPD (pharmacokinetic / pharmacodynamics) modeling for biologic drugs • Combines theoretical with practical aspects of ADME in biologic drug discovery and development and compares innovator biologics with biosimilar biologics and small molecules with biologics, giving a lessons-learned perspective • Includes case studies about leveraging ADME to improve biologics drug development for monoclonal antibodies, fusion proteins, pegylated proteins, ADCs, bispecifics, and vaccines • Presents regulatory expectations and industry perspectives for developing biologic drugs in USA, EU, and Japan • Provides mechanistic insight into biodistribution and target-driven pharmacokinetics in important sites of action such as tumors and the brain

Protein Therapeutics

Protein Therapeutics Book
Author : Zuben E. Sauna,Chava Kimchi-Sarfaty
Publisher : Springer
Release : 2017-07-19
ISBN : 3319418181
Language : En, Es, Fr & De

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Book Description :

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

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals Book
Author : Feroz Jameel,Susan Hershenson
Publisher : John Wiley & Sons
Release : 2010-07-13
ISBN : 0470595876
Language : En, Es, Fr & De

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Book Description :

A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase–appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

Challenges in Protein Product Development

Challenges in Protein Product Development Book
Author : Nicholas W. Warne,Hanns-Christian Mahler
Publisher : Springer
Release : 2018-06-20
ISBN : 3319906038
Language : En, Es, Fr & De

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Book Description :

In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.

Analysis of Aggregates and Particles in Protein Pharmaceuticals

Analysis of Aggregates and Particles in Protein Pharmaceuticals Book
Author : Hanns-Christian Mahler,Wim Jiskoot
Publisher : John Wiley & Sons
Release : 2011-12-20
ISBN : 1118150562
Language : En, Es, Fr & De

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Book Description :

This book describes how to address the analysis of aggregates and particles in protein pharmaceuticals, provides a comprehensive overview of current methods and integrated approaches used to quantify and characterize aggregates and particles, and discusses regulatory requirements. Analytical methods covered in the book include separation, light scattering, microscopy, and spectroscopy.

Pharmaceutical Biotechnology

Pharmaceutical Biotechnology Book
Author : Gary Walsh
Publisher : John Wiley & Sons
Release : 2013-04-25
ISBN : 111868575X
Language : En, Es, Fr & De

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Book Description :

Pharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals. With a particular focus on the subject taken from a pharmaceutical perspective, initial chapters offer a broad introduction to protein science and recombinant DNA technology- key areas that underpin the whole subject. Subsequent chapters focus upon the development, production and analysis of these substances. Finally the book moves on to explore the science, biotechnology and medical applications of specific biotech products categories. These include not only protein-based substances but also nucleic acid and cell-based products. introduces essential principles underlining modern biotechnology- recombinant DNA technology and protein science an invaluable introduction to this fast-moving subject aimed specifically at pharmacy and medical students includes specific ‘product category chapters’ focusing on the pharmaceutical, medical and therapeutic properties of numerous biopharmaceutical products. entire chapter devoted to the principles of genetic engineering and how these drugs are developed. includes numerous relevant case studies to enhance student understanding no prior knowledge of protein structure is assumed

Protein Therapeutics

Protein Therapeutics Book
Author : Tristan Vaughan,Jane Osbourn,Bahija Jallal
Publisher : John Wiley & Sons
Release : 2017-07-28
ISBN : 3527699139
Language : En, Es, Fr & De

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Book Description :

In this practice-oriented two volume handbook, professionals from some of the largest biopharmaceutical companies and top academic researchers address the key concepts and challenges in the development of protein pharmaceuticals for medicinal chemists and drug developers of all trades. Following an introduction tracing the rapid development of the protein therapeutics market over the last decade, all currently used therapeutic protein scaffolds are surveyed, from human and non-human antibodies to antibody mimetics, bispecific antibodies and antibody-drug conjugates. This ready reference then goes on to review other key aspects such as pharmacokinetics, safety and immunogenicity, manufacture, formulation and delivery. The handbook then takes a look at current key clinical applications for protein therapeutics, from respiratory and inflammation to oncology and immune-oncology, infectious diseases and rescue therapy. Finally, several exciting prospects for the future of protein therapeutics are highlighted and discussed.

Fusion Protein Technologies for Biopharmaceuticals

Fusion Protein Technologies for Biopharmaceuticals Book
Author : Stefan R. Schmidt
Publisher : John Wiley & Sons
Release : 2013-01-28
ISBN : 1118354583
Language : En, Es, Fr & De

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Book Description :

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.

Therapeutic Peptides and Proteins

Therapeutic Peptides and Proteins Book
Author : Ajay K. Banga
Publisher : CRC Press
Release : 2015-04-23
ISBN : 1466566078
Language : En, Es, Fr & De

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Book Description :

There are more than 500 biopharmaceuticals on the market, including more than 200 therapeutic proteins, making biologics the fastest growing sector in the biopharmaceutical market. These products include more than 40 monoclonal antibodies, for indications ranging from treatment or mitigation of various types of cancer to rheumatoid arthritis. The clinical application of these therapeutic peptides and proteins is limited by several problems, such as lack of physical and chemical stability or the lack of desirable attributes for adequate absorption or distribution. Thus, as these therapeutic peptides and proteins are made available, it will be essential to formulate these drugs into safe, stable, and efficacious delivery systems. The pharmaceutical scientist involved in this effort needs to call upon the knowledge of several disciplines, such as pharmaceutics, medicinal chemistry, biochemistry, microbiology, and chemical engineering and needs to keep abreast with the latest research in the published literature. Therapeutic Peptides and Proteins: Formulation, Processing, and Delivery Systems, Third Edition provides a comprehensive overview of the field for scientists in industry and academia and for students, while also providing practical information on the challenges facing the formulation and delivery aspects of these unique macromolecules. In particular, the book: Explains how recombinant DNA techniques now allow us to produce therapeutic proteins in a commercially viable form Discusses the physical and chemical pathways of peptide and protein degradation Includes a detailed discussion of protein formulation and lyophilization Overviews the pharmacokinetic aspects of therapeutic peptides and proteins and discusses controlled delivery systems for parenteral administration, including microsphere formulations Discusses research progress on oral, transdermal, mucosal, and topical delivery systems discusses transdermal and topical delivery

PEGylated Protein Drugs Basic Science and Clinical Applications

PEGylated Protein Drugs  Basic Science and Clinical Applications Book
Author : Francesco M. Veronese
Publisher : Springer Science & Business Media
Release : 2009-12-30
ISBN : 3764386797
Language : En, Es, Fr & De

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Book Description :

PEGylation technology and key applications are introduced by this topical volume. Basic physical and chemical properties of PEG as basis for altering/improving in vivo behaviour of PEG-conjugates such as increased stability, improved PK/PD, and decreased immunogenicity, are discussed. Furthermore, chemical and enzymatic strategies for the coupling and the conjugate characterization are reported. Following chapters describe approved and marketed PEG-proteins and PEG-oligonucleotides as well as conjugates in various stages of clinical development.