Therapeutic Protein Drug Products

Therapeutic Protein Drug Products Book PDF
✏Book Title : Therapeutic Protein Drug Products
✏Author : Brian K Meyer
✏Publisher : Elsevier
✏Release Date : 2012-01-02
✏Pages : 200
✏ISBN : 9781908818102
✏Available Language : English, Spanish, And French

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✏Therapeutic Protein Drug Products Book Summary : 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

📒Therapeutic Proteins ✍ C. Mark Smales

Therapeutic Proteins Book PDF
✏Book Title : Therapeutic Proteins
✏Author : C. Mark Smales
✏Publisher : Springer Science & Business Media
✏Release Date : 2005
✏Pages : 482
✏ISBN : 9781592599226
✏Available Language : English, Spanish, And French

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✏Therapeutic Proteins Book Summary : This volume contains contributions from leaders in the field of therapeutic protein expression, purification, characterization, formulation and viral inactivation who cover all aspects of protein drug production downstream of the discovery stage. Protocols for the production of therapeutic proteins using a variety of sources are covered. including bacterial and yeast expression systems, insect and mammalian cells. Therapeutic Proteins: Methods and Protocols will prove an invaluable resourse to all those working in the field of therapeutic protein production.

Aggregation Of Therapeutic Proteins Book PDF
✏Book Title : Aggregation of Therapeutic Proteins
✏Author : Wei Wang
✏Publisher : John Wiley & Sons
✏Release Date : 2010-12-28
✏Pages : 484
✏ISBN : 1118043588
✏Available Language : English, Spanish, And French

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✏Aggregation of Therapeutic Proteins Book Summary : 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.

Challenges In Protein Product Development Book PDF
✏Book Title : Challenges in Protein Product Development
✏Author : Nicholas W. Warne
✏Publisher : Springer
✏Release Date : 2018-07-22
✏Pages : 599
✏ISBN : 9783319906034
✏Available Language : English, Spanish, And French

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✏Challenges in Protein Product Development Book Summary : 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.

Biophysics For Therapeutic Protein Development Book PDF
✏Book Title : Biophysics for Therapeutic Protein Development
✏Author : Linda O. Narhi
✏Publisher : Springer Science & Business Media
✏Release Date : 2013-02-26
✏Pages : 293
✏ISBN : 9781461443162
✏Available Language : English, Spanish, And French

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✏Biophysics for Therapeutic Protein Development Book Summary : 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.

Pharmaceutical Formulation Development Of Peptides And Proteins Book PDF
✏Book Title : Pharmaceutical Formulation Development of Peptides and Proteins
✏Author : Lars Hovgaard
✏Publisher : CRC Press
✏Release Date : 2012-11-14
✏Pages : 392
✏ISBN : 9781439853894
✏Available Language : English, Spanish, And French

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✏Pharmaceutical Formulation Development of Peptides and Proteins Book Summary : 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 therap

Handbook Of Biogeneric Therapeutic Proteins Book PDF
✏Book Title : Handbook of Biogeneric Therapeutic Proteins
✏Author : Sarfaraz K. Niazi
✏Publisher : CRC Press
✏Release Date : 2002-08-15
✏Pages : 584
✏ISBN : 9781000611328
✏Available Language : English, Spanish, And French

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✏Handbook of Biogeneric Therapeutic Proteins Book Summary : More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products. Even with all the regulato

📒Therapeutic Proteins ✍ Vladimir Voynov

Therapeutic Proteins Book PDF
✏Book Title : Therapeutic Proteins
✏Author : Vladimir Voynov
✏Publisher : Humana Press
✏Release Date : 2016-05-01
✏Pages : 516
✏ISBN : 1493959492
✏Available Language : English, Spanish, And French

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✏Therapeutic Proteins Book Summary : 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."

Biological Drug Products Book PDF
✏Book Title : Biological Drug Products
✏Author : Wei Wang
✏Publisher : John Wiley & Sons
✏Release Date : 2013-08-29
✏Pages : 744
✏ISBN : 9781118695227
✏Available Language : English, Spanish, And French

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✏Biological Drug Products Book Summary : Tested and proven solutions to the challenges of biologicaldrug product development Biological drug products play a central role in combating humandiseases; however, developing new successful biological drugspresents many challenges, including labor intensive productionprocesses, tighter regulatory controls, and increased marketcompetition. This book reviews the current state of the science,offering readers a single resource that sets forth the fundamentalsas well as tested and proven development strategies for biologicaldrugs. Moreover, the book prepares readers for the challenges thattypically arise during drug development, offering straightforwardsolutions to improve their ability to pass through all theregulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with generalconsiderations for the development of any biological drug productand then explores the strategies and challenges involved in thedevelopment of specific types of biologics. Divided into fiveparts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts inbiological drug development. Contributions are based on acomprehensive review and analysis of the current literature as wellas the authors' first-hand experience developing and testing newdrugs. References at the end of each chapter serve as a gateway tooriginal research papers and reviews in the field. By incorporating lessons learned and future directions forresearch, Biological Drug Products enables pharmaceuticalscientists and students to improve their success rate in developingnew biologics to treat a broad range of human diseases.

Peptide And Protein Drug Analysis Book PDF
✏Book Title : Peptide and Protein Drug Analysis
✏Author : Ronald Reid
✏Publisher : CRC Press
✏Release Date : 1999-11-12
✏Pages : 904
✏ISBN : 1420001337
✏Available Language : English, Spanish, And French

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✏Peptide and Protein Drug Analysis Book Summary : 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.

Monitoring Polymerization Reactions Book PDF
✏Book Title : Monitoring Polymerization Reactions
✏Author : Wayne F. Reed
✏Publisher : John Wiley & Sons
✏Release Date : 2013-12-02
✏Pages : 488
✏ISBN : 9781118733974
✏Available Language : English, Spanish, And French

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✏Monitoring Polymerization Reactions Book Summary : Offers new strategies to optimize polymer reactions With contributions from leading macromolecular scientists and engineers, this book provides a practical guide to polymerization monitoring. It enables laboratory researchers to optimize polymer reactions by providing them with a better understanding of the underlying reaction kinetics and mechanisms. Moreover, it opens the door to improved industrial-scale reactions, including enhanced product quality and reduced harmful emissions. Monitoring Polymerization Reactions begins with a review of the basic elements of polymer reactions and their kinetics, including an overview of stimuli-responsive polymers. Next, it explains why certain polymer and reaction characteristics need to be monitored. The book then explores a variety of practical topics, including: Principles and applications of important polymer characterization tools, such as light scattering, gel permeation chromatography, calorimetry, rheology, and spectroscopy Automatic continuous online monitoring of polymerization (ACOMP) reactions, a flexible platform that enables characterization tools to be employed simultaneously during reactions in order to obtain a complete record of multiple reaction features Modeling of polymerization reactions and numerical approaches Applications that optimize the manufacture of industrially important polymers Throughout the book, the authors provide step-by-step strategies for implementation. In addition, ample use of case studies helps readers understand the benefits of various monitoring strategies and approaches, enabling them to choose the best one to match their needs. As new stimuli-responsive and "intelligent" polymers continue to be developed, the ability to monitor reactions will become increasingly important. With this book as their guide, polymer scientists and engineers can take full advantage of the latest monitoring strategies to optimize reactions in both the lab and the manufacturing plant.

Therapeutic Monoclonal Antibodies Book PDF
✏Book Title : Therapeutic Monoclonal Antibodies
✏Author : Zhiqiang An
✏Publisher : John Wiley & Sons
✏Release Date : 2011-09-20
✏Pages : 896
✏ISBN : 9781118210260
✏Available Language : English, Spanish, And French

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✏Therapeutic Monoclonal Antibodies Book Summary : 70-chapter authoritative reference that covers therapeutic monoclonal antibody discovery, development, and clinical applications while incorporating principles, experimental data, and methodologies. First book to address the discovery and development of antibody therapeutics in their entirety. Most chapters contain experimental data to illustrate the principles described in them. Authors provide detailed methodologies that readers can take away with them and use in their own laboratories.

📒Therapeutic Proteins ✍ Roland Kontermann

Therapeutic Proteins Book PDF
✏Book Title : Therapeutic Proteins
✏Author : Roland Kontermann
✏Publisher : John Wiley & Sons
✏Release Date : 2012-01-31
✏Pages : 372
✏ISBN : 9783527644780
✏Available Language : English, Spanish, And French

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✏Therapeutic Proteins Book Summary : For this ready reference, the internationally renowned authority in the field, Roland Kontermann, has assembled a team of outstanding contributors from industry and academia to convey the worldwide knowledge on modifying therapeutic proteins in order to optimize their pharmacological potential. The result is a comprehensive work covering all approaches and aspects of the topic in one handy volume, making this indispensable reading for companies and research institutions working on the development of biopharmaceuticals.

Supercritical Fluid Technology For Drug Product Development Book PDF
✏Book Title : Supercritical Fluid Technology for Drug Product Development
✏Author : Peter York
✏Publisher : CRC Press
✏Release Date : 2004-03-23
✏Pages : 632
✏ISBN : 9780824751029
✏Available Language : English, Spanish, And French

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✏Supercritical Fluid Technology for Drug Product Development Book Summary : Interconnecting the fundamentals of supercritical fluid (SCF) technologies, their current and anticipated utility in drug delivery, and process engineering advances from related methodological domains and pharmaceutical applications, this volume unlocks the potential of supercritical fluids to further the development of improved pharmaceutical products-from drug powders for respiratory delivery to drug delivery systems for controlled release.

📒Sterile Drug Products ✍ Michael J. Akers

Sterile Drug Products Book PDF
✏Book Title : Sterile Drug Products
✏Author : Michael J. Akers
✏Publisher : CRC Press
✏Release Date : 2016-04-19
✏Pages : 516
✏ISBN : 9781420020564
✏Available Language : English, Spanish, And French

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✏Sterile Drug Products Book Summary : Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This book is based on the courses he has delivered for over three decades, to over 3000 participants, and is intended to remain relevant for the indefinite future even as new technologies and new applications of old technologies become common. This is an ideal reference book for those working directly and indirectly with sterile dosage forms, be it product development (formulation, package, process, analytical), manufacturing, quality control, quality assurance, regulatory, purchasing, or project management. This book is also intended as an educational resource for the pharmaceutical and biopharmaceutical industry and pharmacy schools, providing basic knowledge and principles in four main areas of parenteral science and technology: Product development, including formulation, packaging, and process development. Manufacturing, including basic teaching on all the primary unit operations involved in preparation of sterile products and the underlying importance of contamination control. Quality and regulatory, including the application of good manufacturing practice regulations, aseptic processing guidelines, and unique quality control testing methods for the sterile dosage form Clinical aspects, including administration, potential hazards, and biopharmaceutics of sterile products in a clinical setting.

Therapeutic Peptides And Proteins Book PDF
✏Book Title : Therapeutic Peptides and Proteins
✏Author : Ajay K. Banga
✏Publisher : CRC Press
✏Release Date : 1997-07-01
✏Pages : 317
✏ISBN : 1566763290
✏Available Language : English, Spanish, And French

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✏Therapeutic Peptides and Proteins Book Summary : From the Preface At the time of this writing, the American biotechnology and pharmaceutical industry has more than two dozen biotechnology-derived therapeutic proteins on the market, while several hundred are in various stages of human clinical trials or at the FDA for review. Today, more than a thousand companies are involved in biotechnology research, with a total revenue of $7.7 billion for 1993. Therapeutic peptides and proteins are expected to mitigate suffering in coming years as anticancer agents, hormones, growth factors, analgesics, anti-hypertensives, and thrombolytics, among others. However, 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, and microbiology, and needs to keep abreast with the latest research in the published literature. This book presents these principles in a simple, interesting and practically useful manner for the benefit of scientists working in this area and to further research in this area. This book will also provide useful information for students and academic researchers and add to their interest in this area. The book should also be useful in a hospital setting to understand potential physicochemical stability problems that may result during reconstitution or administration of the new recombinant proteins. Since this field is relatively new and rapidly evolving, efforts were made to include very recent literature in the book. As a result, over 40% of the literature citations in the book are for the work published in the last two years.

📒Polypeptide Protein Drugs ✍ Robert Charles Hider

Polypeptide Protein Drugs Book PDF
✏Book Title : Polypeptide Protein Drugs
✏Author : Robert Charles Hider
✏Publisher : CRC Press
✏Release Date : 1991-04-01
✏Pages : 281
✏ISBN : 0136772536
✏Available Language : English, Spanish, And French

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✏Polypeptide Protein Drugs Book Summary : 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.

Biotechnology And Biopharmaceuticals Book PDF
✏Book Title : Biotechnology and Biopharmaceuticals
✏Author :
✏Publisher : John Wiley & Sons
✏Release Date : 2013-09-19
✏Pages : 744
✏ISBN : 9781118659984
✏Available Language : English, Spanish, And French

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✏Biotechnology and Biopharmaceuticals Book Summary : 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.

Drug Product Development For The Back Of The Eye Book PDF
✏Book Title : Drug Product Development for the Back of the Eye
✏Author : Uday B. Kompella
✏Publisher : Springer Science & Business Media
✏Release Date : 2011-08-03
✏Pages : 592
✏ISBN : 9781441999207
✏Available Language : English, Spanish, And French

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✏Drug Product Development for the Back of the Eye Book Summary : This comprehensive volume discusses approaches for a systematic selection of delivery systems for various classes of therapeutic agents including small molecule, protein, and nucleic acid drugs. Specific topics covered in this book include: Solution, suspension, gel, nanoparticle, microparticle, and implant dosage forms Refillable and microneedle devices Intravitreal, suprachoroidal, intrascleral, transscleral, systemic, and topical routes of delivery Physical methods including iontophoresis for drug delivery Rational selection of routes of administration and delivery systems Noninvasive and continuous drug monitoring Regulatory path to drug product development Clinical endpoints for drug product development Emerging and existing drugs and drug targets Drug Product Development for the Back of the Eye is authored by renowned ocular drug delivery experts, representing academic, clinical, and industrial organizations and serves as indispensable resource for ophthalmic researchers, drug formulation scientists, drug delivery and drug disposition scientists, as well as clinicians involved in designing and developing novel therapeutics for the back of the eye diseases. This book is also relevant for students in various disciplines including ophthalmology, pharmaceutical sciences, drug delivery, and biomedical engineering. Refillable and microneedle devices Intravitreal, suprachoroidal, intrascleral, transscleral, systemic, and topical routes of delivery Physical methods including iontophoresis for drug delivery Rational selection of routes of administration and delivery systems Noninvasive and continuous drug monitoring Regulatory path to drug product development Clinical endpoints for drug product development Emerging and existing drugs and drug targets Drug Product Development for the Back of the Eye is authored by renowned ocular drug delivery experts, representing academic, clinical, and industrial organizations and serves as indispensable resource for ophthalmic researchers, drug formulation scientists, drug delivery and drug disposition scientists, as well as clinicians involved in designing and developing novel therapeutics for the back of the eye diseases. This book is also relevant for students in various disciplines including ophthalmology, pharmaceutical sciences, drug delivery, and biomedical engineering. Refillable and microneedle devices Intravitreal, suprachoroidal, intrascleral, transscleral, systemic, and topical routes of delivery Physical methods including iontophoresis for drug delivery Rational selection of routes of administration and delivery systems Noninvasive and continuous drug monitoring Regulatory path to drug product development Clinical endpoints for drug product development Emerging and existing drugs and drug targets Drug Product Development for the Back of the Eye is authored by renowned ocular drug delivery experts, representing academic, clinical, and industrial organizations and serves as indispensable resource for ophthalmic researchers, drug formulation scientists, drug delivery and drug disposition scientists, as well as clinicians involved in designing and developing novel therapeutics for the back of the eye diseases. This book is also relevant for students in various disciplines including ophthalmology, pharmaceutical sciences, drug delivery, and biomedical engineering.

📒Drugs From Natural Products ✍ Alan L. Harvey

Drugs From Natural Products Book PDF
✏Book Title : Drugs From Natural Products
✏Author : Alan L. Harvey
✏Publisher : Pearson Education
✏Release Date : 1993-06
✏Pages : 171
✏ISBN : 0130965464
✏Available Language : English, Spanish, And French

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✏Drugs From Natural Products Book Summary : This book reviews the potential of drug compounds obtained from plant and animal, as well as microbial and fungal origin. Drug design and computer-aided structural analysis are covered in detail, reviewing approaches to the production of therapeutic protein drugs, the biological control of weeds, and specific examples of natural-product drugs such as relaxants and immunomodulators.

Pharmaceutical Dosage Forms And Drug Delivery Second Edition Book PDF
✏Book Title : Pharmaceutical Dosage Forms and Drug Delivery Second Edition
✏Author : Ram I. Mahato
✏Publisher : CRC Press
✏Release Date : 2011-10-25
✏Pages : 512
✏ISBN : 9781439849187
✏Available Language : English, Spanish, And French

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✏Pharmaceutical Dosage Forms and Drug Delivery Second Edition Book Summary : In the second edition of Pharmaceutical Dosage Forms and Drug Delivery the authors integrate aspects of physical pharmacy, biopharmaceuticals, drug delivery, and biotechnology, emphasizing the increased attention that the recent spectacular advances in dosage form design and drug delivery, gene therapy, and nanotechnology have brought to the field. Highlights of the Second Edition: Additional author Ajit S. Narang brings an industrial practitioner perspective with increased focus on pharmacy math and statistics, and powders and granules Reorganized into three parts: Introduction, Physicochemical Principles, and Dosage Forms Chapters on pharmaceutical calculations, compounding principles, and powders and granules provide a complete spectrum of application of pharmaceutical principles Expansion of review questions and answers clarifies concepts for students and adds to their grasp of key concepts covered in the chapter Coverage of complexation and protein binding aspects of physical pharmacy includes the basic concepts as well as recent progress in the field Although there are numerous books on the science of pharmaceutics and dosage form design, most cover different areas of the discipline and do not provide an integrated approach to the topics. This book not only provides a singular perspective of the overall field, but it supplies a unified source of information for students, instructors, and professionals.

📒Pharmaceutical Biotechnology ✍ Daan J. A. Crommelin

Pharmaceutical Biotechnology Book PDF
✏Book Title : Pharmaceutical Biotechnology
✏Author : Daan J. A. Crommelin
✏Publisher : Springer Science & Business Media
✏Release Date : 2013-10-22
✏Pages : 544
✏ISBN : 9781461464860
✏Available Language : English, Spanish, And French

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✏Pharmaceutical Biotechnology Book Summary : This introductory text explains both the basic science and the applications of biotechnology-derived pharmaceuticals, with special emphasis on their clinical use. It serves as a complete one-stop source for undergraduate/graduate pharmacists, pharmaceutical science students, and for those in the pharmaceutical industry. The Fourth Edition will completely update the previous edition, and will also include additional coverage on the newer approaches such as oligonucleotides, siRNA, gene therapy and nanotech.

Biophysical Methods For Biotherapeutics Book PDF
✏Book Title : Biophysical Methods for Biotherapeutics
✏Author : Tapan K. Das
✏Publisher : John Wiley & Sons
✏Release Date : 2014-02-27
✏Pages : 376
✏ISBN : 9781118354681
✏Available Language : English, Spanish, And French

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✏Biophysical Methods for Biotherapeutics Book Summary : With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development. • Helps formulation and analytical scientists in pharma and biotech better understand and use biophysical methods • Chapters organized according to the sequential nature of the drug development process • Helps formulation, analytical, and bioanalytical scientists in pharma and biotech better understand and usestrengths and limitations of biophysical methods • Explains how to use biophysical methods, the information obtained, and what needs to be presented in a regulatory filing, assess impact on quality and immunogenicity • With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development.

Characterization Of Protein Therapeutics Using Mass Spectrometry Book PDF
✏Book Title : Characterization of Protein Therapeutics using Mass Spectrometry
✏Author : Guodong Chen
✏Publisher : Springer Science & Business Media
✏Release Date : 2014-07-08
✏Pages : 404
✏ISBN : 9781441978622
✏Available Language : English, Spanish, And French

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✏Characterization of Protein Therapeutics using Mass Spectrometry Book Summary : This book highlights current approaches and future trends in the use of mass spectrometry to characterize protein therapies. As one of the most frequently utilized analytical techniques in pharmaceutical research and development, mass spectrometry has been widely used in the characterization of protein therapeutics due to its analytical sensitivity, selectivity, and specificity. This book begins with an overview of mass spectrometry techniques as related to the analysis of protein therapeutics, structural identification strategies, quantitative approaches, followed by studies involving characterization of process related protein drug impurities/degradants, metabolites, higher order structures of protein therapeutics. Both general practitioners in pharmaceutical research and specialists in analytical sciences will benefit from this book that details step-by-step approaches and new strategies to solve challenging problems related to protein therapeutics research and development.

Mammary Gland Transgenesis Therapeutic Protein Production Book PDF
✏Book Title : Mammary Gland Transgenesis Therapeutic Protein Production
✏Author : Fidel O. Castro
✏Publisher : Springer Science & Business Media
✏Release Date : 1998-02-12
✏Pages : 222
✏ISBN : 3540637125
✏Available Language : English, Spanish, And French

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✏Mammary Gland Transgenesis Therapeutic Protein Production Book Summary : This book presents the latest in mammary gland transgenesis, the exploitation of transgenic technology for the production of therapeutic proteins by routine or conventional methods. Following a section with an overview of all relevant methodologies, readers will find relevant information on the regulation of milk gene expression and bioreactor species such as cattle, rabbits and pigs.

Delivery Technologies For Biopharmaceuticals Book PDF
✏Book Title : Delivery Technologies for Biopharmaceuticals
✏Author : Lene Jorgensen
✏Publisher : John Wiley & Sons
✏Release Date : 2009-10-23
✏Pages : 442
✏ISBN : 9780470688403
✏Available Language : English, Spanish, And French

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✏Delivery Technologies for Biopharmaceuticals Book Summary : Advances in biotechnology have provided scientists with an increasing number of biopharmaceuticals such as novel peptide and protein drugs as well as nucleic acid based drugs for gene therapy. However, successful delivery of these biopharmaceuticals is a major challenge because their molecular properties lead to poor physical and chemical stability in the body and limited membrane permeability. Therefore researchers are developing a range of new delivery technologies and materials to enable these new drugs to be delivered intact to their target sites. Delivery Technologies for Biopharmaceuticals describes strategies to overcome the main barriers for successful delivery of therapeutic peptides, proteins, and nucleic acid-based drugs or vaccines related to the site of administration and the target site. Many of the approaches described are reported in formulations in current clinical trials as well as in marketed products. Contents include: challenges in delivery of biopharmaceuticals novel formulation approaches for peptide and protein injectables non-viral chemical vectors and viral technology for delivery of nucleic acid based drugs immune response, adjuvants and delivery systems for vaccines several examples of delivery systems for different biopharmaceuticals a critical assessment of delivery technologies for biopharmaceuticals Delivery Technologies for Biopharmaceuticals is an essential single-volume introduction to the technologies used by researchers to ensure efficient delivery of this exciting new class of drugs. It will be of value to researchers and students working in drug delivery, formulation, biopharmaceuticals, medicinal chemistry, and new materials development.

Protein Formulation And Delivery Second Edition Book PDF
✏Book Title : Protein Formulation and Delivery Second Edition
✏Author : Eugene J. McNally
✏Publisher : CRC Press
✏Release Date : 2007-10-26
✏Pages : 376
✏ISBN : 0849379520
✏Available Language : English, Spanish, And French

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✏Protein Formulation and Delivery Second Edition Book Summary : This title is intended to assist pharmaceutical scientists in the development of stable protein formulations during the early stages of the product development process, providing a comprehensive review of mechanisms and causes of protein instability in formulation development, coverage of accelerated stability testing methods and relevant analytical methods, and an overview of the drug substance manufacturing process. Preformulation and the development of traditional solutions and lyophilized formulations frequently used for intravenous delivery and non-traditional formulations are also addressed. Because many developments in the field have emerged since the publication of the First Edition, this Second Edition addresses important new patient-friendly developments in the field, such as formulation for implantable devices, needle-free formulation and delivery approaches, and oral delivery of proteins.

📒Monoclonal Antibodies ✍ Steven Shire

Monoclonal Antibodies Book PDF
✏Book Title : Monoclonal Antibodies
✏Author : Steven Shire
✏Publisher : Woodhead Publishing
✏Release Date : 2015-04-24
✏Pages : 224
✏ISBN : 9780081002971
✏Available Language : English, Spanish, And French

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✏Monoclonal Antibodies Book Summary : 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

Approved Prescription Drug Products Book PDF
✏Book Title : Approved Prescription Drug Products
✏Author :
✏Publisher :
✏Release Date : 1981
✏Pages :
✏ISBN : UOM:39015072931572
✏Available Language : English, Spanish, And French

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✏Approved Prescription Drug Products Book Summary : Accompanied by supplements.

📒Basic Biotechnology ✍ Colin Ratledge

Basic Biotechnology Book PDF
✏Book Title : Basic Biotechnology
✏Author : Colin Ratledge
✏Publisher : Cambridge University Press
✏Release Date : 2001-04-19
✏Pages : 568
✏ISBN : 0521779170
✏Available Language : English, Spanish, And French

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✏Basic Biotechnology Book Summary : Biotechnology: what it is, how it's used, and how you do it!